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Rule2022-17230

Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids

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Published

August 17, 2022

Effective

October 17, 2022

Issuing agencies

Health and Human Services DepartmentFood and Drug Administration

Abstract

The Food and Drug Administration (FDA, we, or the Agency) is establishing a regulatory category for over-the-counter (OTC) hearing aids and making related amendments to update the regulatory framework for hearing aids. Specifically, we define OTC hearing aids and establish applicable requirements; amend existing rules for consistency with the new OTC category; repeal the conditions for sale applicable to hearing aids; amend the existing labeling requirements for hearing aids; and update regulations relating to decisions on applications for exemption from Federal preemption that will become obsolete as a result of changes to the hearing aid requirements. In creating a regulatory category for OTC hearing aids and amending existing rules, we intend to provide reasonable assurance of safety and effectiveness for these devices as well as foster access to, and innovation in, hearing aid technology, thereby protecting and promoting the public health.

Full Text

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[Federal Register Volume 87, Number 158 (Wednesday, August 17, 2022)]
[Rules and Regulations]
[Pages 50698-50762]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-17230]

[[Page 50697]]

Vol. 87

Wednesday,

No. 158

August 17, 2022

Part II

Department of Health and Human Services

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Food and Drug Administration

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21 CFR Parts 800, 801, et al.

Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-
Counter Hearing Aids; Final Rule

Federal Register / Vol. 87 , No. 158 / Wednesday, August 17, 2022 /
Rules and Regulations

[[Page 50698]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 800, 801, 808, and 874

[Docket No. FDA-2021-N-0555]
RIN 0910-AI21

Medical Devices; Ear, Nose, and Throat Devices; Establishing
Over-the-Counter Hearing Aids

AGENCY: Food and Drug Administration, Department of Health and Human
Services (HHS).

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA, we, or the Agency) is
establishing a regulatory category for over-the-counter (OTC) hearing
aids and making related amendments to update the regulatory framework
for hearing aids. Specifically, we define OTC hearing aids and
establish applicable requirements; amend existing rules for consistency
with the new OTC category; repeal the conditions for sale applicable to
hearing aids; amend the existing labeling requirements for hearing
aids; and update regulations relating to decisions on applications for
exemption from Federal preemption that will become obsolete as a result
of changes to the hearing aid requirements. In creating a regulatory
category for OTC hearing aids and amending existing rules, we intend to
provide reasonable assurance of safety and effectiveness for these
devices as well as foster access to, and innovation in, hearing aid
technology, thereby protecting and promoting the public health.

DATES:
Effective date: This rule is effective October 17, 2022.
Compliance dates: For hearing aids that have been legally offered
for sale prior to October 17, 2022, including hearing aids that already
have a 510(k) clearance, compliance with the new or revised
requirements must be achieved by April 14, 2023. For hearing aids that
have not been offered for sale prior to October 17, 2022, or have been
offered for sale but are required to submit a new 510(k) due to changes
unrelated to this rule, compliance with the new or revised requirements
applicable to the hearing aid, and obtaining 510(k) clearance if
applicable, must be achieved before marketing the device on or after
October 17, 2022.
Incorporation by reference: The incorporation by reference of
certain material listed in this rule is approved by the Director of the
Federal Register as of October 17, 2022.

ADDRESSES: For access to the docket to read background documents or
comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the
docket number, found in brackets in the heading of this final rule,
into the ``Search'' box and follow the prompts and/or go to the Dockets
Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852,
240-402-7500.

FOR FURTHER INFORMATION CONTACT:
With regard to the final rule: Srinivas Nandkumar, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Silver Spring, MD 20993, 301-796-6480,
<a href="/cdn-cgi/l/email-protection#c390b1aaadaab5a2b0ed8da2ada7a8b6aea2b183a5a7a2edababb0eda4acb5">[email&#160;protected]</a>.
With regard to the information collection: Amber Sanford, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867,
<a href="/cdn-cgi/l/email-protection#d585879486a1b4b3b395b3b1b4fbbdbda6fbb2baa3">[email&#160;protected]</a>.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary
Purpose of the Final Rule
Summary of the Major Provisions of the Final Rule
Legal Authority
Costs and Benefits
II. Table of Abbreviations and Acronyms Commonly Used in this
Document
III. Background
A. Need for the Regulation
B. History of this Rulemaking and Public Participation
C. Summary of Changes Between Proposed and Final Rules
D. Incorporation by Reference
IV. Legal Authority
V. Comments on the Proposed Rule and FDA's Responses
A. Device Classification and Marketing
B. Scope (Sec. 800.30(a))
C. Definitions (Sec. Sec. 800.30(b) and 801.422(b))
D. Labeling (Sec. 800.30(c))
E. Output Limits (Sec. 800.30(d))
F. Other Device Requirements (Sec. 800.30(e) and (f))
G. Conditions for OTC Sale (Sec. 800.30(g))
H. Preemption Provisions (Sec. 800.30(h))
I. Repeal of Restrictions and Modifications for Prescription
Labeling (Sec. Sec. 801.420, 801.421, 801.422)
J. Other Amendments
VI. Effective and Compliance Dates
A. Effective Date
B. Compliance Dates for Hearing Aids Not Legally Offered for
Sale Prior to the Effective Date
C. Compliance Dates for Hearing Aids Legally Offered for Sale
Prior to the Effective Date
VII. Economic Analysis of Impacts
VIII. Analysis of Environment Impact
IX. Paperwork Reduction Act of 1995
X. Federalism
XI. Consultation and Coordination with Indian Tribal Governments
XII. References

I. Executive Summary

A. Purpose of the Final Rule

B. Summary of the Major Provisions of the Final Rule

FDA is establishing a regulatory category for OTC hearing aids to
improve access to hearing aid technology for Americans. OTC hearing
aids are intended to address perceived mild to moderate hearing loss in
people aged 18 or older. Along with the OTC category, we are finalizing
multiple related changes to the overall regulatory framework for
hearing aids to harmonize existing rules with the new OTC category. We
have determined that the requirements set forth in this rulemaking will
protect the public health by providing reasonable assurance of safety
and effectiveness for hearing aids, as well as promote the hearing
health of Americans by lowering barriers to access and fostering
innovation in hearing aid technology.
Among other things, FDARA amended the Federal Food, Drug, and
Cosmetic Act (FD&C Act) by defining OTC hearing aids and providing the
authorities to establish the OTC category of hearing aids among
provisions that are, by definition, general controls. We are finalizing
general controls for OTC hearing aids consistent with FDARA.

[[Page 50699]]

We are finalizing lower output limits than we proposed but have not
substantially changed the other electroacoustic performance
requirements for OTC hearing aids. We have simplified the phrasing
throughout the required labeling and have restated the maximum
insertion depth for OTC hearing aids in terms of a fixed measurement.
However, we are not realigning the air-conduction hearing aid
classification regulations as proposed.
This rulemaking also affects other regulations that applied to
hearing aids. FDA had established device restrictions for hearing aids
that included labeling requirements as well as conditions for sale. We
are removing these device restrictions for hearing aids and
establishing a new regulation for prescription hearing aid labeling.
Further, FDA had by regulation granted or denied exemptions from
Federal preemption for State requirements pertaining to hearing aids.
The removal of the device restrictions on hearing aids, as well as
certain provisions of FDARA, impact most of these previous exemption
decisions, for example, by altering their scope. We are removing the
regulations codifying these decisions and establishing other
regulations clarifying some of the effects of statutory preemption
under FDARA.

C. Legal Authority

The FD&C Act establishes a comprehensive system for the regulation
of devices intended for human use. Hearing aids are devices intended
for human use and so are subject to, among other requirements, the
device provisions of the FD&C Act. FDA has authority to establish
regulatory controls needed to provide reasonable assurance of safety
and effectiveness for these devices. As such, FDA is establishing
regulatory controls for OTC hearing aids and amending regulatory
controls for prescription hearing aids. Moreover, the FD&C Act directs
the establishment of an electronic radiation control program, and
hearing aids and personal sound amplification products (PSAPs) are
electronic products, subject to the electronic radiation control
requirements.
Specific to OTC hearing aids, the FD&C Act and FDARA authorize
multiple controls, including authority for FDA to establish
requirements for device labeling, output limits, conditions for sale
and distribution, and other requirements that provide reasonable
assurance of safety and effectiveness of OTC hearing aids. FDARA
specifically directs FDA to establish a category of OTC hearing aids by
regulation that must include the aforementioned requirements.
More generally, the FD&C Act further provides for labeling
requirements as general controls such that devices (and other medical
products) will not be misbranded. The FD&C Act also authorizes FDA to
issue regulations for the efficient enforcement of the FD&C Act. We are
establishing the following regulations pursuant to these authorities
and to fulfill the directive under FDARA.
Additionally, both the FD&C Act and FDARA include preemption
provisions applicable to hearing aids.

D. Costs and Benefits

This rule to establish OTC hearing aids and align other regulations
generates potential cost savings for consumers with perceived mild to
moderate hearing impairment who wish to buy lower cost hearing aids not
bundled with professional services and not requiring professional
advice, fitting, adjustment, or maintenance but who are currently
unable to buy such products online because of State regulations or
because they do not shop online. This rule also generates costs for
hearing aid manufacturers for changing labeling of existing hearing
aids as well as for reading the rule and revising internal standard
operating procedures in response to the rule. We estimate benefits of
between $6 million and $147 million per year based on 5th and 95th
percentile Monte Carlo results with a mean of $63 million per year. We
estimate annualized costs of between $1 million and $2 million per year
based on 5th and 95th percentile Monte Carlo results with a mean of $1
million per year. Combining benefits and costs, we used Monte Carlo
analysis to estimate annualized net benefits of between $5 million and
$145 million per year based on the 5th and 95th Monte Carlo percentile
results with a mean of $62 million per year at both 3 percent and 7
percent discount rates.

II. Table of Abbreviations and Acronyms Commonly Used in This Document

------------------------------------------------------------------------
Abbreviation/acronym What it means
------------------------------------------------------------------------
510(k)....................... A premarket notification for certain
devices.
ANSI......................... American National Standards Institute.
APA.......................... Administrative Procedure Act.
ASA.......................... Acoustical Society of America.
ASHA......................... American Speech-Language-Hearing
Association.
CDRH......................... Center for Devices and Radiological
Health.
CFR.......................... Code of Federal Regulations.
cm\3\........................ Centimeter cubed (cubic centimeter).
CTA.......................... Consumer Technology Association.
dB........................... Decibel.
dBA.......................... A-weighted decibel.
EA........................... Environmental assessment.
ENT.......................... Ear-Nose-Throat.
FDA.......................... Food and Drug Administration.
FD&C Act..................... Federal Food, Drug, and Cosmetic Act.
FDARA........................ FDA Reauthorization Act of 2017.
FONSI........................ Finding of no significant impact.
FR........................... Federal Register.
FRIA......................... Final Regulatory Impact Analysis.
IQA.......................... Information Quality Act.
ISO.......................... International Organization for
Standardization.
ITU.......................... International Telecommunication Union.
mm........................... Millimeter.
ms........................... Millisecond.

[[Page 50700]]

MSW.......................... Municipal solid waste.
NASEM........................ National Academies of Sciences,
Engineering, and Medicine.
NIOSH........................ National Institute for Occupational
Safety and Health.
OMB.......................... Office of Management and Budget.
OSPL90....................... Output sound pressure level with 90-dB
input.
OTC.......................... Over-the-counter.
PRA.......................... Paperwork Reduction Act of 1995.
PSAP......................... Personal sound amplification product.
Pub. L....................... Public Law.
RMS.......................... Root mean square.
SPL.......................... Sound pressure level.
U.S.C........................ United States Code.
WHO.......................... World Health Organization.
------------------------------------------------------------------------

III. Background

FDA is defining and establishing general controls for an OTC
category of hearing aids. We intend these controls to provide for
reasonable assurance of safety and effectiveness for these devices,
thereby protecting the public health. We also intend these controls to
help improve access to and foster innovation in hearing aid technology
for Americans, thereby promoting the public health. We are making
various other revisions, as described in this document, to align
existing regulations with statutory requirements and the new OTC
category.
For brevity, we will use the following terms as shorthand in this
document: ``Over-the-Counter Hearing Aid Controls'' for the general
controls for OTC hearing aids that we are finalizing under Sec. 800.30
(21 CFR 800.30).
``Commercial activity involving OTC hearing aids'' to refer to any
or all of the following activities: servicing, marketing, sale,
dispensing, use, customer support, or distribution of OTC hearing aids
through in-person transactions, by mail, or online.
``Customizable'' or ``customization,'' unless otherwise noted, to
refer to the elements of the statutory definition for OTC hearing aids
described in section 520(q)(1)(A)(iii) and (iv) of the FD&C Act (21
U.S.C. 360j(q)(1)(A)(iii) and (iv)). That is, for the purposes of this
document, a customizable hearing aid is one that, through tools, tests,
or software, allows the user to control the hearing aid and customize
it to the user's hearing needs. To do so, the hearing aid may use
wireless technology or include tests for self-assessment of hearing
loss. (See also the response to Comment 1 explaining customization in
more technical terms.)
``Involvement of a licensed person'' to refer to the supervision,
prescription, or other order, involvement, or intervention of a
licensed person.
``State or local requirement'' to refer to any State or local law,
regulation, order, or other requirement.

A. Need for the Regulation

Hearing loss affects an estimated 30 million people in the United
States and can have a significant impact on communication, social
participation, and overall health and quality of life (Refs. 1 and 2).
Despite the high prevalence and public health impact of hearing loss,
only about one-fifth of people who could benefit from a hearing aid
seek intervention (Ref. 3). The use of hearing aids has been linked to,
among other health benefits, reductions in the incidence or severity of
cognitive decline, depression, and other health problems in older
adults (Refs. 2, 4, and 5). Additionally, benefits of hearing aid use
can include improved social participation and a better quality of life.
Besides health benefits for individuals, more-widespread adoption
of hearing aids could have broader effects. By increasing social
participation, hearing aids could help to improve inclusion of
individuals in family, economic, civic, and religious life. Thus,
reducing barriers to hearing aid access might contribute to such
improvements. This could be particularly true for people of color,
rural Americans, low-income individuals, and others for whom barriers
to hearing aid access may be especially burdensome.
Several barriers likely impede the use of hearing aids in hearing-
impaired individuals such as high cost, stigma of being perceived as
old or debilitated, and value (perceived hearing benefit relative to
price) (Ref. 6). FDA is finalizing rules to address some of these
concerns.
Moreover, section 709 of FDARA directs FDA to establish a category
of OTC hearing aids through rulemaking, and sets forth various
requirements for OTC hearing aids, including for reasonable assurance
of safety and effectiveness, as well as Federal preemption provisions.
In addition to protecting and promoting the public health, these rules
establish the OTC category and implement the requirements of FDARA.

B. History of This Rulemaking and Public Participation

On October 20, 2021, in the Federal Register, FDA proposed multiple
regulatory changes, including proposing requirements for OTC hearing
aids, that would serve to provide reasonable assurance of safety and
effectiveness of hearing aids, address barriers to access to hearing
aids, and effectuate the requirements of section 709 of FDARA (86 FR
58150). Although the October 2021 proposal was the first step in this
rulemaking, the proposal followed other steps FDA had already taken to
initiate an update of the regulatory framework for hearing aids. Please
refer to the aforementioned issue of the Federal Register for further
details on the proposal and other steps taken by FDA.
We received more than 1,000 comments on the proposed rule by the
close of the comment period, which was January 18, 2022. Commenters
included consumers, professionals, professional associations, hearing
aid manufacturers, public health organizations, public advocacy groups,
members of Congress, and State agencies. We describe and respond to the
comments in section V of this document. We have grouped similar
comments together under the same number, and in some cases, we have
separated different issues discussed in the same comment and designated
them as distinct comments for purposes of our responses. The number
assigned to each comment or comment topic is purely for organizational
purposes and does not signify the comment's value or importance or the
order in which we received comments.

[[Page 50701]]

C. Summary of Changes Between Proposed and Final Rules

In response to comments, we have made (and declined) a number of
changes for the final rule. The following summarizes the outcomes that
may be of greatest interest to readers:
Output limits. We are finalizing lower output limits than we
proposed. The general limit will be 111 decibels of sound pressure
level (dB SPL), with 117 dB SPL allowable for devices while input-
controlled compression is activated.
Gain limit. We did not propose, and are not finalizing, a separate
gain limit.
Design requirements. We have revised the allowable insertion depth.
The most medial (innermost) component of an OTC hearing aid must be
reasonably expected to remain at least 10 millimeters (mm) from the
tympanic membrane (eardrum). We are also requiring that all OTC hearing
aids have a user-adjustable volume control.
Labeling. We have improved phrasing throughout the labeling to make
it more understandable for hearing aid users (non-experts).
Conditions for sale. We are not requiring age verification for the
sale of OTC hearing aids. Prescription hearing aid sales will be
subject to the requirements in Sec. 801.109 (21 CFR 801.109),
including that they be sold only to or on the prescription or other
order of a practitioner licensed by law to use or order the use of
(prescribe) the devices (which is as proposed).
Scope and definitions. Perceived mild to moderate hearing
impairment remains the scope of the intended use of OTC hearing aids,
and we are declining to require measurements of hearing loss to
establish prospective users' qualification to purchase OTC hearing
aids.
OTC category and self-fitting air-conduction hearing aid
classification. We are not requiring that OTC hearing aids be self-
fitting devices, and we have provided clarification on the difference
between customization and fitting.
Quality System requirements. OTC hearing aids will be subject to
the requirements under part 820 (21 CFR part 820), which describes a
quality management system appropriate for medical devices.
We explain those decisions and others, as well as provide our
thinking on other topics in the sections that follow.

D. Incorporation by Reference

FDA is incorporating by reference ANSI/CTA-2051, ``Personal Sound
Amplification Performance Criteria,'' dated January 2017, which was
approved by the Office of the Federal Register. You may obtain a copy
from the Consumer Technology Association (CTA), 1919 S. Eads St.,
Arlington, VA 22202; <a href="https://www.cta.tech">https://www.cta.tech</a>, 703-907-7600. Among other
things, it describes how to measure frequency response and includes
technical data for adaptations for different circumstances and provides
a standardized way to quantify frequency response for OTC hearing aids
and to meet the related electroacoustic performance requirements.
FDA is also incorporating by reference ANSI/ASA S3.22-2014 (R2020),
``Specification of Hearing Aid Characteristics,'' dated June 5, 2020,
which was approved by the Office of the Federal Register. You may
obtain a copy from the Acoustical Society of America (ASA), 1305 Walt
Whitman Road, Suite 300, Melville, NY 11747 Telephone: 1 (631) 390-
0215, Fax: 1 (631) 923-2875, Email: <a href="/cdn-cgi/l/email-protection#6b0a180a181f0f182b0a08041e181f02080a07180408020e1f124504190c">[email&#160;protected]</a> or
the American National Standards Institute (ANSI), 1889 L Street NW,
11th Floor, Washington, DC 20036; <a href="https://www.ansi.org">https://www.ansi.org</a>, 202-293-8020.
ANSI/ASA S3.22-2014 (R2020) describes tolerances and test methods used
for certain measurements of hearing aid performance. The application of
ANSI/ASA S3.22-2014 (R2020) provides professional hearing instrument
specialists with standardized technical information to help them select
the correct hearing aid and ensure optimal fit and performance for
hearing aid users.

IV. Legal Authority

The FD&C Act establishes a comprehensive system for the regulation
of devices, as defined in section 201(h) of the FD&C Act (21 U.S.C.
321(h)), intended for human use. Section 513 of the FD&C Act (21 U.S.C.
360c) defines three classes of devices, reflecting the regulatory
controls needed to provide reasonable assurance of their safety and
effectiveness. The three classes of devices are class I (general
controls), class II (special controls), and class III (premarket
approval) (see 21 U.S.C. 360c). Hearing aids are devices intended for
human use and are subject to the FD&C Act. Currently, air-conduction
hearing aids are generally either class I or class II devices.
The FD&C Act also directs the establishment of an electronic
product radiation control program under section 532(a) to protect the
public health and safety (see 21 U.S.C. 360ii(a)), and requires, among
other things, that manufacturers of electronic products provide
notification of certain defects (see 21 U.S.C. 360ll). Section
531(1)(B) of the FD&C Act defines electronic product radiation as,
among other phenomena, any sonic, infrasonic, or ultrasonic wave
emitted from an electronic product as the result of the operation of an
electronic circuit (see 21 U.S.C. 360hh(1)(B)). In turn, any
manufactured or assembled product which, when in operation, contains or
acts as part of an electronic circuit and emits (or in the absence of
effective shielding or other controls would emit) electronic product
radiation would be an electronic product (see 21 U.S.C. 360hh(2)(A)).
As such, hearing aids and PSAPs emit electronic product radiation and
are electronic products, meaning they are subject to the electronic
product radiation control requirements.
FDARA amended the FD&C Act to apply requirements specific to
certain hearing aids and defined the term ``over-the-counter hearing
aid'' (see 21 U.S.C. 360j(q)). We are issuing these requirements for
OTC hearing aids pursuant to section 709(b) of FDARA, which authorizes
FDA to establish requirements for labeling, output limits, conditions
for sale and distribution of OTC hearing aids, and other requirements
that provide for reasonable assurance of safety and effectiveness of
these devices.
In addition, the FD&C Act provides that a device is misbranded
unless, among other requirements, its labeling bears adequate
directions for use (see section 502(f)(1) of the FD&C Act (21 U.S.C.
352(f)(1)). Consistent with section 502 of the FD&C Act, FDA has issued
regulations that exempt certain kinds of devices from the requirement
for adequate directions for use. Section 502(f)(2) further requires
adequate warnings against use of a device in those pathological
conditions, or by children, where use of the device may be dangerous to
health. The labeling must also bear adequate warnings against unsafe
dosage or methods or duration of administration or application (see
section 502(f)(2) of the FD&C Act). Such warnings must be in such
manner and form as are necessary for the protection of the users (see
section 502(f)(2) of the FD&C Act).
A device is also misbranded if its labeling is false or misleading
in any particular (see section 502(a) of the FD&C Act). Section 201(n)
of the FD&C Act states that in determining whether labeling or
advertising is misleading, there shall be taken into account not only
representations made or suggested but also the extent to which labeling
or advertising fails to reveal material facts.
Other misbranding provisions under the FD&C Act would apply as
well,

[[Page 50702]]

including section 502(c), which deems a device to be misbranded if any
word, statement, or other information required by or under authority of
the FD&C Act to appear on the label or labeling is not prominently
placed thereon with such conspicuousness and in such terms as to render
it likely to be read and understood by the ordinary individual under
customary conditions of purchase and use.
Additionally, section 701(a) of the FD&C Act authorizes FDA to
issue regulations for the efficient enforcement of the FD&C Act (21
U.S.C. 371(a)). The regulations established in this rulemaking are for
the efficient enforcement of the FD&C Act because they will provide
standards for the legal marketing of safe and effective hearing aids.
Violations of any final rules from this rulemaking, once in effect,
would render the hearing aids adulterated and/or misbranded under
sections 501 and/or 502 of the FD&C Act, and subject to enforcement
action, for example, seizure (see section 304 of the FD&C Act (21
U.S.C. 334)), injunction (see section 302 of the FD&C Act (21 U.S.C.
332)), and criminal prosecution (see section 303 of the FD&C Act (21
U.S.C. 333)). Prohibited acts include, among others, introducing an
adulterated or misbranded device into interstate commerce (see section
301 of the FD&C Act (21 U.S.C. 331)). Sections 538 and 539 of the FD&C
Act additionally set forth prohibited acts and provisions for
enforcement for electronic product radiation control (see 21 U.S.C.
360oo and 360pp, respectively).
Under section 521 of the FD&C Act, no State or political
subdivision of a State may establish or continue in effect with respect
to a device intended for human use any requirement that is different
from, or in addition to, any requirement applicable under the FD&C Act
to the device and that relates to the safety or effectiveness of the
device or to any other matter included in a requirement applicable to
the device under the FD&C Act (21 U.S.C. 360k). Section 521 of the FD&C
Act also provides that FDA may grant an exemption from preemption under
certain circumstances. Section 709(b) of FDARA also includes a
preemption provision with respect to requirements for OTC hearing aids.

V. Comments on the Proposed Rule and FDA's Responses

In the proposed rule, FDA welcomed comments on all aspects of the
proposal, and we specifically requested comments on certain topics to
encourage more-targeted feedback. Such topics included:

the clarity of the definitions and ways to improve them;
labeling requirements;
equitable access to hearing aids and information about them;
whether State or local requirements for returns would promote or
restrict or interfere with commercial activities involving OTC
hearing aids;
design requirements to limit insertion depth;
proposals for modification of, or alternatives to, the current
applicable Quality System requirements for OTC hearing aids;
conditions for sale of OTC hearing aids to prevent sale to or
for people younger than 18;
the removal of regulations in 21 CFR part 808 (part 808)
regarding exemptions from Federal preemption for State and local
requirements respecting hearing aids;
possible effects of the rule on small manufacturers;
data concerning the environmental assessment and our proposal
for a finding of no significant impact (FONSI);
topics related to the Paperwork Reduction Act of 1995 (PRA) and
associated estimates for recordkeeping burdens; and
potential impacts on Indian Tribes from this rulemaking.

As appropriate, we summarize such comments that we received, along
with other pertinent comments, and respond to them in the corresponding
subsections that follow. As we indicated in the proposal, we considered
only comments submitted to the docket for this rulemaking that were
timely and pertinent (see 86 FR 58150-58161).
The vast majority of comments that we received supported rulemaking
to encourage wider adoption of safe and effective hearing aids for
people who could benefit from them. FDA agrees that rulemaking can
encourage wider adoption of such devices, and we expect this final rule
to do so. Many commenters conveyed enthusiasm for affordable hearing
aids and/or wider availability without the involvement of a licensed
person, telling us that they expect the difference to make hearing aids
accessible to them--in some cases, for the first time. Some comments
observed that hearing impairment often correlates with lower income,
suggesting that lower prices may be particularly helpful for people who
may want to use hearing aids and that OTC hearing aids could serve an
important role in achieving equitable health outcomes.
Still, many commenters voiced both support and concern for the role
of licensed persons and the value of professional services for hearing
health. In finalizing this rule, FDA is not suggesting that licensed
persons or their professional services are unimportant or not valuable.
Indeed, we recommend consulting licensed persons in several
circumstances, including for the diagnosis of hearing impairment and in
the fitting and continued use of OTC hearing aids when consumers choose
to seek such services. Many commenters asserted that the professional
services are worth the cost. In that vein, one comment suggested that,
like providing alternative distribution channels, increasing the number
of audiologists and other hearing health care providers would also
improve accessibility. This final rule, however, focuses on subjects
within FDA's purview, establishing device requirements that provide
reasonable assurance of safety and effectiveness for OTC hearing aids
without the involvement of a licensed person, as directed by FDARA.
As for specific provisions, the comments generally supported
establishing requirements for labeling, output (volume) limits,
electroacoustic performance requirements, and other design requirements
for OTC hearing aids. However, individual comments varied on the extent
to which they supported specific proposals or proffered alternatives.
Comments that provided a rationale and/or evidence generally lent more
insight for FDA's consideration.
We acknowledge that some comments did not support this rulemaking,
many of them stating that hearing aids are medical devices and should
not be regulated as consumer electronics. We interpret such comments to
mean that OTC hearing aids should not have a relaxed standard for
safety or effectiveness, nor should OTC hearing aids be subject to less
stringent requirements for product quality than other medical devices.
We agree that OTC hearing aids must meet the same standard as other
devices for having reasonable assurance of safety and effectiveness,
consistent with the FD&C Act and section 709 of FDARA, and that OTC
hearing aids be subject to the quality system requirements applicable
to other devices. However, we note that different device types and
categories will raise different issues related to safety and
effectiveness. Thus, while devices must meet the same standard of
having reasonable assurance of safety and effectiveness, different
device types and categories can engender different regulatory
requirements to achieve the same standard. This final rule establishes
requirements specific to hearing aids and although the requirements for
OTC and prescription hearing aids are not the same, these requirements,
along with other applicable requirements under the FD&C Act, provide
for reasonable assurance of safety and effectiveness for

[[Page 50703]]

both categories of hearing aids (we note that in this document when we
describe the requirements in Sec. 800.30 (21 CFR 800.30) or Sec.
801.422 (21 CFR 801.422) as providing reasonable assurance of safety
and effectiveness, we mean in conjunction with other applicable
requirements under the FD&C Act).

A. Device Classification and Marketing

We received several comments about the interplay among device
classification regulations, the OTC Hearing Aid Controls, and premarket
notification requirements. Generally, we agree that clarification on
such issues will help ensure that manufacturers identify and follow the
appropriate regulatory requirements for their devices.
(Comment 1) Multiple comments requested clarification on the
difference between self-fitting hearing aids classified under Sec.
874.3325 (21 CFR 874.3325) and hearing aids that, through tools, tests,
or software allow users to control the hearing aids and customize them
to the users' hearing needs. Many such comments pointed out that the
clarification will help manufacturers determine the applicability of
premarket notification requirements and special controls.
(Response) Under section 520(q)(1)(A) of the FD&C Act, an OTC
hearing aid must be controllable by the user and customizable to the
user's hearing needs. We interpret the requirement for customization to
hearing needs to mean that the device must allow the user to cause
frequency-dependent changes based on the user's preference. This is
because a single profile for gain versus frequency is unlikely to
accommodate the majority of hearing needs for perceived mild to
moderate impairment. For example, a flat gain profile across frequency
is unlikely to meet the hearing needs of users with sloping hearing
loss, the kind of impairment often associated with aging, as well as a
non-flat gain profile across frequency would. However, a flat gain
profile across frequency may be preferable for some people with a
different kind of hearing loss. In short, to have reasonable assurance
of safety and effectiveness of OTC hearing aids, the devices must offer
capabilities for a variety of perceived mild to moderate hearing
impairments, and customization is the method or process that allows the
user to match the device output to individual preference.
We interpret the requirement for user control to mean that the user
can access or select the output characteristics most significant to the
user's hearing perception. For an OTC hearing aid, we consider these
characteristics to include the frequency-dependent output profile and
the output volume. The controls must allow the user to select the
output volume and profile according to preference. The user may control
the output profile, for example, with a physical toggle switch, a
selection through a software interface, or providing preferences for
software to select the optimal profile dynamically.
FDA views customization as a more-general concept than self-
fitting. Fitting is a customization process that instills in the device
frequency-dependent settings for the specific user. A self-fitting
process instills frequency-dependent settings through the user
interacting with the device or an accessory to the device. Self-fitting
hearing aids incorporate technology, including software, that
integrates user input with a self-fitting strategy and enables users to
independently derive and customize their hearing aid fitting and
settings (see Sec. 874.3325(a)). A self-fitting strategy is a fitting
process, with the selected output profile intended to correspond to the
user's audiogram more closely than a hearing aid that is not fitted.
Many hearing aids that are customizable but not fitted have a limited
set of standardized output profiles, often called ``presets.''
In considering whether a hearing aid is self-fitting, FDA takes
into account, among other things, the device's design and labeling. For
purposes of distinguishing fitting a hearing aid from selecting among
standardized output profiles, we focus on the determination and
configuration of device settings that would be appropriate for the
specific user, especially the frequency-dependent settings. (However,
this focus does not exclude other factors that would still be relevant
to determining intended use.) For example, a hearing aid outputting a
preset likely would not be self-fitting, but a hearing aid that allowed
the user to make frequency-dependent modifications to a preset to suit
the user's preferences likely would be self-fitting.
FDA recognizes that, because a preset may approach a user's ideal
fitting, a device with several presets may be difficult to distinguish
from a self-fitting device. However, we note that devices with a small
number of presets, for example, three, are not ordinarily considered
self-fitting when the user chooses the profile. However, a hearing aid
with a greater number of profiles would more closely resemble a fitting
process, with the selected output profile intended to correspond to the
user's audiogram more closely, in which case the hearing aid likely
would be considered self-fitting. Similarly, toggling between a small
number of programs, for example, for noise reduction or scene
selection, would generally not indicate self-fitting, but setting or
adjusting compression knee points in frequency sub-bands, would tend to
indicate self-fitting. Moreover, FDA would likely consider a device
that includes self-fitting functionality to be self-fitting, regardless
of whether the individual user takes advantage of the functionality.
In sum, customization need not entail self-fitting, though self-
fitting is a kind of customization. Whether a hearing aid is self-
fitting depends on its intended use, which may be shown by, among other
things, the device's design and labeling (see Sec. 801.4 (21 CFR
801.4)). Some limited feature sets would not ordinarily cause a device
to be a self-fitting hearing aid, while more advanced adjustment
capability, especially for frequency-dependent settings, would tend to
indicate that the device is a self-fitting hearing aid. FDA has made a
minor revision to the requirement to provide specific instructions for
use of tools, tests, or software to clarify that such instructions need
not always refer to self-fitting; such instructions must include
instructions for self-fitting only when the OTC hearing aid is a self-
fitting device (see final Sec. 800.30(c)(2)(vii)(B)).
(Comment 2) Many comments urged FDA: to clarify that the definition
of OTC hearing aids under section 520(q)(1)(A) of the FD&C Act is
synonymous with the identification for self-fitting air-conduction
hearing aids under Sec. 874.3325(a); to declare that self-fitting
hearing aids are OTC devices; to declare that OTC hearing aids must be
self-fitting; and/or to require that OTC hearing aid labeling bear the
description ``self-fitting'' or a similar description.
(Response) Although FDA expects that many OTC hearing aids will be
self-fitting, we do not agree with these comments. As explained in the
response to Comment 1, a hearing aid may be customizable in the manner
required under section 520(q)(1)(A)(iii) of the FD&C Act yet not be
intended to entail fitting. Thus, we are not requiring that OTC hearing
aids be self-fitting devices.
By extension, we are not requiring in this final rule that OTC
hearing aids bear labeling that describes the devices as ``self-
fitting'' or a similar description. However, Sec. 801.61 (21 CFR
801.61) still applies, and this provision requires, among other things,
a statement of identity on the principal display panel of an OTC
device. (See also the responses to Comment 21, regarding other
considerations for self-fitting

[[Page 50704]]

capabilities of OTC hearing aids, and Comment 18, regarding identifying
and selling OTC hearing aids.)
Moreover, FDA intends that any hearing aid that uses the same
fundamental scientific technology as those defined under Sec. Sec.
874.3300(a) (21 CFR 874.3300(a)), 874.3305 (21 CFR 874.3305), and
874.3325 (21 CFR 874.3325) qualify as an OTC hearing aid (provided it
satisfies all other applicable requirements). Some future hearing aid
device types may also meet the statutory definition (and satisfy all
other applicable requirements) to be available over the counter.
Requiring that OTC hearing aids be a currently classified air-
conduction hearing aid could have the effect of limiting the OTC
category to current technologies rather than allowing the category to
extend to new types of hearing aids.
(Comment 3) Some comments requested clarification on what would
qualify as ``tools, tests, or software'' for the purposes of
controlling an OTC hearing aid and customizing it to the user's hearing
needs. Similar comments requested that FDA clarify which legacy and
wireless air-conduction hearing aids would satisfy the customization
requirement but not be a self-fitting hearing aid.
(Response) FDA interprets the requirement for tools, tests, or
software broadly. We would, for example, consider a device that allows
the user to cycle through output profiles with a push-button selector
switch and to set the volume with a knob to meet the requirement.
Should such a hearing aid be sufficiently customizable, and should it
not incorporate wireless or self-fitting technology, then it would
presumably be an air-conduction (``legacy'') hearing aid classified
under Sec. 874.3300 and could be made available OTC. (See the response
to Comment 1 for more about distinguishing customization and fitting.)
(Comment 4) Comments expressed concerns about the potential to
bypass premarket notification requirements and special controls if non-
self-fitting hearing aids could be later configured or modified, for
example, if the manufacturer ``unlocks'' self-fitting software or
provides the user with options for ``advanced settings'' or the like.
They urged FDA to finalize rules to prevent such an outcome.
(Response) Existing requirements already address modifications to
devices, including hearing aids. Under Sec. 807.81(a)(3) (21 CFR
807.81(a)(3)), a 510(k) is required if the device is about to be
significantly changed or modified, namely, a major change or
modification in the intended use or other kind of change or
modification that could significantly affect the safety or
effectiveness of the device. For example, a change or modification that
causes a device to fall within a different classification regulation
would be considered significant. Additionally, as explained in the
response to Comment 1, aspects of the device's design and labeling can
demonstrate the device's intended use (see Sec. 801.4). If a wireless
air-conduction hearing aid later incorporates self-fitting technology
(for example, by downloading software) or such technology is later made
accessible to the user (for example, by ``unlocking'' after an
additional purchase), such a change would almost certainly demonstrate
that the modified device was a self-fitting air-conduction hearing aid
classified under Sec. 874.3325 (assuming it was not a new device
type). As such, it would be subject to the premarket notification
requirements and special controls that apply to self-fitting air-
conduction hearing aids.
In sum, a change in intended use or other aspect can cause a change
in applicable requirements, and a device must comply with applicable
regulatory requirements. As such, if a manufacturer intends to unlock
or similarly upgrade its hearing aid with self-fitting technology such
that it would fall within the self-fitting air-conduction hearing aid
classification regulation, then prior to initial introduction into
interstate commerce of the device, the manufacturer must comply with
applicable requirements, including 510(k) requirements and compliance
with the special controls. (See also the response to Comment 6 about
the information a 510(k) should include.)
(Comment 5) Several comments requested clarification on when
manufacturers of OTC hearing aids would need to submit a premarket
notification, also called a 510(k). Many of these comments urged FDA to
require 510(k)s for all OTC hearing aids.
(Response) FDA's existing requirements and related policies for
submitting 510(k)s apply to hearing aids intended for OTC availability
and use. We are not imposing additional general requirements for
510(k)s.
For manufacturers that have already legally introduced self-fitting
air-conduction hearing aids into interstate commerce, changes to their
devices to satisfy the OTC Hearing Aid Controls may require submission
of a 510(k). However, in certain situations FDA intends not to enforce
the requirement for a 510(k), as discussed in section VI on effective
and compliance dates.
This policy also applies to non-self-fitting devices (wireless air-
conduction and legacy air-conduction hearing aids). However,
manufacturers of non-self-fitting devices may wish to consider the
implications of using a test for somebody besides the user to fit the
device. For devices intended for fitting based off of a user-supplied
audiogram, a requirement for the involvement of a licensed person to
produce the audiogram may cause the device not to be an OTC hearing aid
as defined in section 520(q)(1)(A) of the FD&C Act.
Further, if a manufacturer or other non-licensed person obtains
hearing ability data to customize (or even fit) a hearing aid, the
manufacturer should consider whether the instrument used to obtain the
data is a diagnostic (or other) device. Using a hearing aid with a
diagnostic device may implicate changes to a hearing aid concerning the
compatibility or interoperability with other devices, including other
components or accessories, that could significantly affect the hearing
aid's risk profile, necessitating a 510(k).
Notwithstanding these general principles, in each case,
manufacturers should evaluate any changes in light of FDA's guidance,
``Deciding When to Submit a 510(k) for a Change to an Existing
Device,'' issued October 25, 2017, which describes specific changes
that generally do or do not require premarket notification.\1\
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\1\ The document is available online at: <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-510k-change-existing-device">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-510k-change-existing-device</a>.
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To illustrate: If a manufacturer of a wireless air-conduction
hearing aid updates device labeling and adds a user self-assessment
test intending the test to enable the user to independently customize
and derive the fitting and settings (the device is intended to entail
fitting), then FDA would anticipate the manufacturer would need to
submit a 510(k). FDA's guidance document lists several considerations
that would likely apply. In this example, the changes included:
the directions for use, including the use and application of the
self-test to the device settings (see A4 of the aforementioned guidance
on deciding when to submit a 510(k), ``Could the change affect the
directions for use of the device?'');
the control mechanism and/or operating principle (see B2 of the
same guidance, ``Is it a control mechanism, operating principle, or
energy type change?'');
the device's design, specifically changes to its performance,
components

[[Page 50705]]

or accessories, and human factors of the interface (see B5 of the same
guidance, ``Is it any other change in design (e.g., dimensions,
performance specifications, wireless communication, components or
accessories, or the patient/user interface)?''); and
those that significantly affect its use, potentially necessitating
clinical validation data (see B5.1 and B5.3 of the same guidance,
``Does the change significantly affect the use of the device?'' and
``Are clinical data necessary to evaluate safety or effectiveness for
purposes of design validation?'').
Each of those changes in this example could require a 510(k),
depending on the specifics of the changes. In deciding whether to
submit a 510(k), manufacturers may want to review the guidance in its
entirety since the considerations for the example are not exhaustive
and may or may not be applicable, depending on the specific device.
Manufacturers may also want to review FDA's guidance, ``Deciding When
to Submit a 510(k) for a Software Change to an Existing Device,''
issued October 25, 2017.\2\
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\2\ The document is available online at: <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-510k-software-change-existing-device">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-510k-software-change-existing-device</a>.
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Note that, although a wireless air-conduction hearing aid
classified under Sec. 874.3305, or a legacy air-conduction hearing aid
classified under Sec. 874.3300, is exempt from requirements for
premarket notification, some changes could exceed the limitations of
exemption under Sec. 874.9 (21 CFR 874.9), depending on the specifics.
(Comment 6) Commenters requested clear guidance on the specific
information manufacturers would need to submit in a 510(k) to bring
devices to market quickly, avoiding unnecessary delays or unnecessarily
hindering innovation.
(Response) In addition to the required information specified in the
510(k) procedures under 21 CFR part 807, subpart E, the specific
information that a manufacturer should submit will vary based on the
new device or specific changes made to an existing device. Therefore,
providing specific guidance for all manufacturers in this final rule is
not feasible. However, FDA's usual policies on the content and format
of 510(k)s apply to submissions for hearing aids, including for
modifications made to satisfy applicable special controls and the OTC
Hearing Aid Controls. Manufacturers may wish to review publicly
available information regarding the De Novo classification of self-
fitting air-conduction hearing aids. (See the response to Comment 5
regarding when to submit a 510(k).)
In the case of OTC hearing aids, we anticipate that many
manufacturers that submit a 510(k) could avail themselves of the
Abbreviated 510(k) Program, as described in FDA's guidance of that
name, issued on September 13, 2019.\3\ Should a manufacturer
incorporate self-fitting (or other) technology into one of its existing
legacy or wireless devices and need to submit a 510(k), we would expect
that the manufacturer could leverage the similarity with exempt devices
as a least-burdensome way to obtain marketing authorization for the
device that is not exempt from premarket notification requirements.
Manufacturers of existing devices may not need to re-address questions,
for example, related to electromagnetic compatibility (EMC), provided
the manufacturer has not made changes that would affect EMC and require
a 510(k) under our usual policies. Further, summary reports describing
how the hearing aid complies with applicable special controls may be
especially useful in addressing clinical data that support the
effectiveness of the self-fitting strategy, usability testing, and
software verification, validation, and hazard analysis.
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\3\ The document is available online at: <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/abbreviated-510k-program">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/abbreviated-510k-program</a>.
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Moreover, manufacturers that have decided to submit a 510(k),
whether traditional or abbreviated, may wish to review FDA's guidance,
``Format for Traditional and Abbreviated 510(k)s,'' issued on September
13, 2019.\4\ The guidance provides a general framework for the format
and content of a 510(k).
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\4\ The document is available online at: <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/format-traditional-and-abbreviated-510ks">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/format-traditional-and-abbreviated-510ks</a>.
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(Comment 7) Commenters requested that FDA exempt certain kinds of
hearing aids, including self-fitting devices, from premarket
notification requirements. Some posited that FDA would accrue
sufficient experience with self-fitting air-conduction hearing aids to
evaluate the potential for 510(k) exemption 2 years after the effective
date of this final rule. Others requested that FDA explain how OTC
hearing aids will become 510(k)-exempt.
(Response) FDA's usual policies for exempting devices from
premarket notification requirements apply to self-fitting air-
conduction hearing aids. Stakeholders may wish to review FDA's
guidance, ``Procedures for Class II Device Exemptions from Premarket
Notification,'' issued February 19, 1998.\5\ The guidance lists several
factors that FDA may consider for exemption, including:
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\5\ The document is available online at: <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/procedures-class-ii-device-exemptions-premarket-notification-guidance-industry-and-cdrh-staff">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/procedures-class-ii-device-exemptions-premarket-notification-guidance-industry-and-cdrh-staff</a>.

The history (if any) of false or misleading claims or of risks
associated with inherent characteristics of the device, such as
device design or materials (FDA considers the risks associated with
false or misleading claims, and the frequency, persistence, cause,
or seriousness of the inherent risks of the device);
How characteristics of the device necessary for its safe and
effectiveness performance are well established;
How changes in the device that could affect safety or
effectiveness will either be readily detectable or not materially
increase the risk of injury, incorrect diagnosis, or ineffective
treatment;
How any changes to the device would not be likely to result in a
change in the device's classification; and
The role of the limitations of exemption.

Although the amount of time that has passed since the
classification of the device in question may affect how FDA views the
factors, for example, the history of false or misleading claims, the
amount of time since classification is not generally directly relevant.
That is, 2 years after the effective date of this final rule may or may
not afford sufficient experience and information to exempt all self-
fitting air-conduction hearing aids from premarket notification
requirements. We did not propose to exempt self-fitting air-conduction
hearing aids and are not doing so now (see 86 FR 58150 at 58171).

B. Scope (Sec. 800.30(a))

We received several comments on which devices should be subject to
the OTC Hearing Aid Controls and, conversely, which devices should be
prescription. Sometimes these comments referred to definitions rather
than scope. In this section, we respond to comments on scope, including
comments where the suggested changes to the definitions affect the
scope. The next section of this document, specifically for definitions,
responds to comments that relate more directly to the clarity of terms
or the usefulness of different terms.
(Comment 8) Comments requested clarification on the applicability
of the OTC Hearing Aid Controls in circumstances in which software
intended for compensation for hearing loss operates or adapts the
output of other hearing products such as earbuds or headphones.

[[Page 50706]]

(Response) To date, FDA has not classified a device that adapts the
output of other hearing products, such as earbuds, to compensate for
perceived mild to moderate hearing impairment, including a device that
accomplishes this through software. Overall, FDA encourages innovation
of hearing products that are safe and effective and, to that end,
intends to consider developing guidance to provide clarification on the
applicability of laws and regulations implemented by FDA in
circumstances where software would operate or adapt the output of
hearing products to compensate for perceived mild to moderate hearing
impairment. However, considering that in such circumstances, the
software might be distributed separately from the hearing product, FDA
has added requirements in the OTC Hearing Aid Controls for software
device labeling. Similar requirements for software device labeling were
also added to Sec. 801.422. (See Additional Revision 3 in section
III.D.6 describing the labeling requirements for hearing aid
software.\6\) The software device labeling requirements take into
consideration certain aspects associated with software not distributed
with the hearing product, including that such software may not be
provided in a package.
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\6\ We refer to ``additional revisions'' to indicate changes
that FDA has made in further consideration of comments and the
issues involved in this rulemaking, but that are additional to the
suggestions made explicitly in comments. We have numbered the
Additional Revisions in the order that they appear in this document,
which depends upon the subject of the revision--definitions, outside
package labeling, etc.--not the order in which the Additional
Revisions are cross-referenced in our responses to comments.
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(Comment 9) A comment questioned whether a software interface for
professionals such as audiologists or hearing instrument specialists
would cause a hearing aid to be a prescription device if the
professional could adjust the output in excess of the applicable limit.
(Response) If a manufacturer markets an OTC hearing aid that meets
the OTC hearing aid definition and complies with all applicable
requirements of the OTC Hearing Aid Controls--but also offers an
additional separate feature, a software interface for professionals
that allows only licensed persons to adjust the device output--FDA
likely would not consider the hearing aid to be a prescription device,
but the software interface for professionals would be a prescription
device and therefore must comply with Sec. Sec. 801.422 and 801.109.
(Note that a software interface for an air-conduction hearing aid,
which is the subject of this response, would be distinct from the
hypothetical hearing-aid software device, described in the response to
Comment 8, that operates or adapts the output of other hearing products
such as earbuds or headphones.)
However, the intended use of a device can change after initial
introduction into interstate commerce (see Sec. 801.4). If a
manufacturer intends prescription uses of a device, the manufacturer
should consider how to ensure the device will satisfy all applicable
requirements, for example, prescription labeling requirements. Should a
manufacturer provide or allow users, and not just licensed persons,
ready access to an interface that allows the user to configure the
device to provide output in excess of that allowed for OTC hearing
aids, this would indicate the device is intended for users (not limited
to licensed persons) to set an excessively high output. FDA would be
more likely to determine that the intended use was not for perceived
mild to moderate hearing impairment. Additionally, such a device would
not meet the required output limits in the OTC Hearing Aid Controls.
Therefore, such a device would be considered a prescription hearing aid
and must meet applicable requirements, including those under Sec. Sec.
801.422 and 801.109; otherwise, it would be in violation of the FD&C
Act.
(Comment 10) Some comments suggested that FDA limit the scope of
the OTC Hearing Aid Controls to devices intended only for people with
perceived mild, but not moderate, hearing impairment. Some of these
comments suggested that perceived moderate hearing impairment requires
the involvement of a licensed person for successful treatment, and as
such, hearing aids intended for perceived moderate hearing impairment
should not be available over the counter.
(Response) FDA disagrees that the involvement of a licensed person
is necessary for hearing aids intended for perceived moderate hearing
impairment. We are retaining perceived moderate hearing impairment
within the scope of the OTC Hearing Aid Controls. The question of
whether the involvement of a licensed person would benefit an
individual's hearing healthcare is separate from whether the individual
would benefit from the use of an OTC hearing aid. In other
circumstances, the availability and use of OTC medical products to
treat an illness or impairment does not imply the illness or impairment
is not serious. Similarly, the availability and use of OTC medical
products does not negate the benefit of a licensed person's
involvement. FDA considers the use of OTC hearing aids, even when
intended for perceived moderate hearing impairment, to be such a set of
circumstances.
Further, by statute, OTC hearing aids include devices that are
intended to compensate for perceived moderate hearing impairment, and
such devices are to be available to consumers over the counter without
the involvement of a licensed person (see 21 U.S.C. 360j(q)(1)(A)(ii)
and (v)). Section 709(b) of FDARA requires FDA to issue regulations
that include, among other requirements, provisions for reasonable
assurance of safety and effectiveness. This rule will provide
reasonable assurance of safety and effectiveness, without the
involvement of a licensed person, for OTC hearing aids, including for
hearing aids intended for perceived moderate hearing impairment.
Thus, while the involvement of a licensed person may benefit people
with perceived hearing impairment, whether of a mild or moderate
degree, FDA does not agree that consumers must attempt to obtain such a
benefit prior to purchasing hearing aids over the counter. FDA is
maintaining perceived moderate hearing impairment within the scope of
the OTC Hearing Aid Controls.
(Comment 11) Some comments objected to the inclusion of
``perceived'' when referring to the kind of hearing impairment for
which OTC hearing aids are intended. The commenters express concern
that a person's perception of hearing loss may be too subjective, and
that the use of OTC hearing aids should be based on more objective
measures. Some of the comments suggested that FDA require prospective
users to obtain audiograms, which are graphs or test results showing
the person's ability to hear different frequencies, from a licensed
person prior to purchasing an OTC hearing aid.
Besides obtaining an audiogram, other comments suggested a more
general testing or examination requirement by a licensed person for
prospective users, prior to purchase. In this way, these commenters
suggested, OTC hearing aid users would have more certainty that OTC
hearing aids would appropriately compensate for their hearing
impairment, and/or the prospective user does not have an underlying,
medically treatable cause of hearing impairment, for example, one of
the ``red flag'' conditions. (A ``red flag'' condition is a sign or
symptom that should prompt a consultation with a doctor, preferably an
ear-nose-throat doctor.)
(Response) FDA disagrees. We are retaining ``perceived'' in
reference to a

[[Page 50707]]

person's degree of hearing impairment and the intended use of OTC
hearing aids for legal and policy reasons. The term ``perceived'' is
used in section 520(q)(1)(A)(ii) of the FD&C Act to describe the
intended use for OTC hearing aids. Moreover, objective measurements of
hearing impairment are not necessary for reasonable assurance of safety
and effectiveness of OTC hearing aids.
Relying on perceptions of hearing impairment is also appropriate
because the type and degree of impairment exist on a continuum, as does
a person's perception and experience of the impairment. A given degree
(quantification) of hearing impairment will not necessarily reflect
whether an OTC hearing aid is likely to benefit a specific individual.
We have therefore focused on communication and other perceptual
experiences (such as listening to music) in which an intended user is
likely to suspect or notice--that is, to perceive--hearing impairment.
FDA expects this approach based on perception to assist users and
prospective users better than an approach that does not.
Additionally, while FDA agrees that an audiogram would provide a
prospective user with an objective measure of hearing impairment, we do
not agree that the scope of the OTC Hearing Aid Controls should include
only hearing aids for objectively measured impairments. Such a
limitation is counter to the objectives of section 709 of FDARA,
including making available hearing aids OTC, without the involvement of
a licensed person, to consumers through in-person transactions, by
mail, or online.
We acknowledge that this places some onus on users and prospective
users. However, this is the case with respect to OTC availability of
many medical products, and we are establishing requirements that will
provide reasonable assurance of safety and effectiveness for such
availability of hearing aids. We also observe that, while an audiogram
might help a user or a licensed person tailor the hearing aid, or
initially select it, even a hearing health care provider would still
ask the user how the device sounds to the user. The user's perception
would help the hearing health care provider make further adjustments. A
person's desire to seek and use hearing aids depends more directly upon
that person's perception of their hearing impairment than the
definitive degree of impairment, and even a licensed person fitting and
adjusting the device would also account for the user's perception. (See
also the response to Comment 24 about defining hearing loss
numerically.)
Further, FDA has included information in the labeling requirements
for OTC hearing aids intended to help users understand whether the
devices are suitable based on their perceptions, realistic expectations
for hearing aid use, and suggestions on when to obtain professional
assistance before and after purchase. Should prospective OTC hearing
aid users still feel uncertain about their perceptions of impairment,
notwithstanding the availability of the aforementioned information,
they may choose to obtain or undergo professional testing prior to
purchase.
(Comment 12) Some commenters suggested that FDA require a
prescription for OTC hearing aids.
(Response) FDA disagrees. Requiring a prescription to purchase an
OTC hearing aid would be contrary to the purposes of this rulemaking,
the definition of OTC hearing aids in the FD&C Act, and FDARA which
includes the mandate to establish requirements for hearing aids to be
available over the counter (see section 520(q)(1)(A)(v) of the FD&C Act
and section 709(b)(1) and (b)(2)(D) of FDARA). It also would negate the
probable health benefits created by wider availability of hearing aids,
as we described in the proposal (see 86 FR 58150 at 58152).
(Comment 13) Multiple comments suggested FDA remove dispensing from
the list of commercial activities that FDA included in the definition
of ``licensed person.'' The definition listed commercial activities
involving OTC hearing aids for which a State or locality could not
require the involvement of a licensed person. For example, a State
could not require a person representing as a dispenser of OTC hearing
aids to undertake special licensing or equivalent activities solely for
that reason.
Such comments cited various reasons, for example, that State
regulatory regimes impose obligations on people representing as
dispensers, so referring to the term in the OTC Hearing Aid Controls
would create an inconsistency with State regulatory requirements. Other
comments pointed out that people expect dispensers to have licenses,
and FDA's regulations would be inconsistent with such expectations.
Still others cited the need for dispensers to acquire and/or
demonstrate qualifications prior to dispensing OTC hearing aids.
Similar comments suggested that FDA instead refer to dispensers as
``sellers,'' ``vendors,'' ``merchants,'' or other such terms. These
terms, the comments assert, would distinguish salespeople from hearing
health care providers.
(Response) FDA is not modifying the scope of the OTC Hearing Aid
Controls or the definition of ``licensed person'' to exclude dispensing
of OTC Hearing Aids. As we explained in the proposed rule, FDARA lists
certain activities that may be undertaken with respect to OTC hearing
aids for which a State or locality cannot require the involvement of a
licensed person (see 86 FR 58150 at 58158). One such activity that
FDARA explicitly lists is the dispensing of OTC hearing aids. This
means that, under Federal law, a State or locality cannot require a
dispenser of OTC hearing aids to undertake special licensing or
equivalent activities because that would in essence require the
involvement of a licensed person, contrary to section 709(b)(2)(D) of
FDARA and section 520(q)(1)(A)(v) of the FD&C Act.
Additionally, in establishing the OTC category for hearing aids, we
have developed requirements to provide reasonable assurance of safety
and effectiveness for OTC hearing aids without the involvement of a
licensed person (see section 709(b)(2) of FDARA). Imposing special
licensing requirements or equivalent activities, therefore, is not
necessary to provide reasonable assurance of safety and effectiveness
of OTC hearing aids. Although not required, a purchaser of OTC hearing
aids can still seek the assistance of a licensed person when selecting
a hearing aid.
Since a person may dispense OTC hearing aids without a specialized
license or the need to involve a licensed person, referring to
dispensers by another term such as ``vendor'' or ``seller'' is not
necessary to distinguish dispensing from activities requiring
specialized licensure or the involvement of a licensed person.
Moreover, we have previously defined dispensers as persons engaged in
the sale, lease, or rental of hearing aids (see prior Sec.
801.420(a)(3)). The regulations we are finalizing in this rulemaking
use essentially the same definition. In sum, using alternative titles
for dispensers may serve to confuse consumers by unnecessarily
establishing another term for a legally permissible activity as well as
incorrectly implying that FDA's interpretation of the term has changed.
FDA recognizes that State and local requirements sometimes
incorporate the term ``dispenser,'' and multiple States impose
requirements on account of dispensing hearing aids. However, FDARA
section 709(b)(4), to summarize, provides that no State or local
government shall continue in effect certain State or local requirements
that are different from, in addition to, or otherwise not identical to
the

[[Page 50708]]

regulations issued under FDARA section 709(b). Thus, regardless of
whether a State or locality amends or otherwise updates its
requirements, it may not continue in effect the inconsistent
requirements prior to their amendment or repeal.
As we explained in the proposal, despite the fact that licensure is
not required for dispensing OTC hearing aids, some persons may
voluntarily identify as a ``licensed dispenser,'' (see 86 FR 58150 at
58168). Although a State or locality could not require dispensers (or
other persons) to undertake special licensing solely on account of
commercial activity involving OTC hearing aids, a State or locality
could still establish licensure criteria that would apply to those
voluntarily identifying as licensed persons. In such a case, the
dispenser's identification as a licensed person would imply that the
dispenser complies with applicable State or local licensing
requirements, albeit voluntarily. (See also the responses to Comment
15, discussing other licensing considerations, and Comment 127,
discussing the involvement of a licensed person for prescription
hearing aids.)
In sum, in light of Federal statutory and other requirements,
including those that provide reasonable assurance of safety and
effectiveness of OTC hearing aids, FDA is not narrowing the scope of
the OTC Hearing Aid Controls to exclude dispensing. This does not,
however, prevent dispensers of OTC hearing aids from voluntarily
subjecting themselves to State or local licensing requirements to
obtain a license (or its equivalent).
(Comment 14) Comments suggested that OTC hearing aids be available
for all degrees of hearing impairment, including degrees greater than
moderate. Some of these comments further noted that Medicare does not
currently pay for or reimburse the cost of hearing aids. As such, the
comments asserted that OTC hearing aids should be usable as lower-cost
alternatives to prescription hearing aids for individuals with more-
profound impairments.
(Response) For the reasons explained in the response to Comment 10,
FDA is establishing requirements for perceived mild to moderate hearing
impairment. Thus, the appropriate device output limit that we are
establishing would not extend to hearing impairment that would require
a greater output than that which is appropriate for perceived moderate
hearing impairment.
However, devices of the same type may generally be intended either
for prescription or OTC use. For example, a manufacturer marketing an
OTC wireless hearing aid could also market another wireless hearing aid
with a higher output than that permitted for OTC hearing aids. This
higher output would render it a prescription device. As with other
products that have differing uses but share manufacturing similarities,
a hearing aid manufacturer may be able to realize economies of scale by
selling an OTC version and a prescription version of hearing aids that
fall within the same type, which in turn could lower the prices for
prescription hearing aids. (See also the response to Comment 17 about
limitations on FDA's authority to require reimbursement for devices.)
(Comment 15) Some comments suggested FDA define which activities
involving hearing aids would require licensure.
(Response) FDA does not generally determine which activities
involving medical products require licensure. However, section
709(b)(4) of FDARA lists several activities for which States or
localities may not require specialized licensure for, or the
involvement of a licensed person in, commercial activity involving OTC
hearing aids. These listed activities are the servicing, marketing,
sale, dispensing, use, customer support, or distribution of OTC hearing
aids through in-person transactions, by mail, or online. As we
explained in the proposal, we interpret the listed activities broadly,
so for example, the term ``sale'' would include leases or rentals (see
86 FR 58150 at 58165).
States usually determine the requirements for licensure or the
involvement of licensed persons. States may still do so with respect to
hearing aids when not prohibited by section 709(b)(4) of FDARA (and
other applicable laws). Where section 709(b)(4) of FDARA does not list
an activity, when construing the terms broadly, a State may require
licensure for that activity as it relates to OTC hearing aids. We note
that the proposal provided a discussion and some examples (see 86 FR
58150 at 58167-58168). Thus, for example, a State may require a license
for a hearing aid fitter, because ``fitting'' is not listed among the
activities in section 709(b)(4) of FDARA, and we do not interpret any
of the listed activities to include fitting. A person could not be a
fitter in that State, even for OTC hearing aids, without a license.
However, the State could not require a hearing aid fitting prior to a
user purchasing an OTC hearing aid because that would restrict or
interfere with commercial activity involving OTC hearing aids. See the
response to Comment 13 for further explanation.
Thus, a State may still establish criteria for licensing dispensers
should a person voluntarily decide to become a licensed dispenser of
OTC hearing aids. In other words, although a State cannot require a
license for dispensing OTC hearing aids, a State can establish what a
person must do to obtain, and claim to have, a license for dispensing
hearing aids. FDA expects that States may wish to continue in effect
licensing requirements to dispense prescription hearing aids, and we
expect that some hearing aid dispensers may wish to obtain a license in
the event they desire to advertise as ``licensed'' and/or to sell
prescription hearing aids in addition to OTC hearing aids.
(Comment 16) Some comments urged FDA to limit the scope of OTC
availability as much as possible, at least in the beginning. These
comments conveyed concerns for the absence of a licensed person in
various roles, including education and counseling. One such comment
suggested that a more-limited scope would be easier to broaden later
than the reverse, limiting a broader scope.
(Response) In the proposed rule, we explained that several barriers
likely impede people's access to hearing aids, including among others,
Federal and State regulatory requirements (see 86 FR 58150 at 58152,
58154). We are undertaking this rulemaking in part to remove or reduce
such barriers to access by establishing requirements that will provide
reasonable assurance of safety and effectiveness while encouraging
broad availability (see 86 FR 58150 at 58158). Moreover, we received a
wealth of thoughtful and nuanced comments about the scope of the OTC
Hearing Aid Controls, including this Comment, and we have determined
that a more-restrictive approach is not necessary for reasonable
assurance of safety and effectiveness of OTC hearing aids. Considering
our purpose to broaden access and our determinations regarding
reasonable assurance of safety and effectiveness, we do not agree that
narrowing the scope of the OTC Hearing Aid Controls, with the intention
of considering a broader scope later, is currently an appropriate
strategy.
(Comment 17) Some comments noted the role of health insurers,
including Medicare, in a person's ability to obtain hearing aids.
Comments suggested that FDA focus on payments or reimbursements for
hearing aids, potentially including financial incentives.
(Response) FDA does not have authority to require payors to pay for
or reimburse the cost of hearing aids or to offer financial incentives
to obtain the

[[Page 50709]]

devices. However, we intend this rule, among other ends, to broaden
access to hearing aids by eliminating certain kinds of requirements
that likely add to the cost of accessing the devices. For example, we
are establishing rules to make OTC hearing aids available without the
involvement of a licensed person.

C. Definitions (Sec. Sec. 800.30(b) and 801.422(b))

This section focuses on explaining the final definitions.
Generally, commenters sought clarity, and we have generally accepted or
declined suggestions with the goal of improving clarity of the
definitions.
(Comment 18) Multiple comments proposed that FDA use another name
to identify OTC hearing aids. For example, some comments proposed
``over-the-counter hearing device,'' ``self-fit over-the-counter
hearing device,'' ``hearing amplifiers,'' and ``hearing devices.''
Generally, these commenters sought to avoid confusion with existing
devices for both consumers and State regulators. Otherwise, commenters
believed, consumers may be misled into believing that OTC hearing aids
are equivalent to prescription hearing aids with respect to
performance, safety, and effectiveness, and there may be regulatory
issues for State licensing boards. Other comments argued that the
availability of OTC devices through retailers such as grocery or
department stores would suggest that these devices are not hearing
aids, so referring to them as such would be inappropriate.
By identifying OTC hearing aids in a different way, consumers,
regulators, and other stakeholders would, the comments argued, have a
clearer indication of devices subject to the new regulatory category.
Many such comments noted that the use of a term other than ``hearing
aid'' was recommended by the National Academies of Sciences,
Engineering, and Medicine (NASEM) in their report, ``Hearing Health
Care for Adults: Priorities for Improving Access and Affordability,''
and by the Hearing Care Associations in their Consensus Paper,
``Regulatory Recommendations for OTC Hearing Aids: Safety &
Effectiveness'' (Ref. 7).
(Response) FDA will continue to use the term ``hearing aids'' to
refer to the OTC and prescription devices subject to this rulemaking
because the use of this term is appropriate. Hearing aids, whether OTC
or prescription, are wearable sound-amplifying devices intended to
compensate for impaired hearing. The term ``hearing aid'' describes
several device types reflected in various classification regulations.
Although OTC hearing aids use air-conduction technology, prescription
hearing aids may do so as well (for example, an air-conduction hearing
aid that provides a higher output than that specified in the OTC
Hearing Aid Controls would be prescription). Therefore, the use of the
term ``hearing aid'' is appropriate to reflect both OTC and
prescription devices that fall within the same device type (for
example, wireless air-conduction hearing aids under Sec. 874.3305).
Moreover, section 520(q)(1)(A) of the FD&C Act explicitly uses and
defines the term ``over-the-counter hearing aid[s],'' and section
709(b)(1) of FDARA requires the establishment of ``a category of over-
the-counter hearing aids.'' Thus, referring to the devices by a
different name would not only be inconsistent with the applicable
classification regulations and statutes, but also FDA expects that
doing so would cause confusion and uncertainty for consumers
considering purchasing an OTC hearing aid.
Further, we expect this rulemaking to broaden the kinds of
retailers that sell OTC hearing aids, helping to increase the
availability of the devices. By extension, the availability of OTC
hearing aids (by that name) in grocery and department stores would help
fulfill one of the purposes of this final rule. Moreover, many
technologically similar products are available and go by several names,
including ``personal amplifier.'' Based on their intended use(s), some
of these may not be devices and/or meet applicable requirements for
devices, yet they may appear to some prospective purchasers to be
suitable alternatives to safe and effective devices.\7\ We expect that
consumers are familiar with the name ``hearing aid,'' and using that
name will better support broadened use of the devices. At the same
time, we expect that introducing yet another name for a similar
technology, albeit regulated as a device, would only serve to increase
confusion in the marketplace because prospective purchasers may think
that a hearing aid could be marketed under other names, including those
used for products that do not meet applicable device requirements.
Thus, we have determined that the best way to indicate whether the
device is subject to this rulemaking is to use the name ``hearing aid''
as used for the device types in the applicable classification
regulations, and the name that is established in the FD&C Act and
FDARA, OTC hearing aids.
---------------------------------------------------------------------------

\7\ FDA is finalizing a guidance alongside this rulemaking to
help stakeholders distinguish hearing aids from PSAPs. To summarize,
a PSAP is an electronic product intended for non-hearing-impaired
people to amplify sounds in certain environments. A PSAP is not
intended to aid with or compensate for impaired hearing.
---------------------------------------------------------------------------

To assist consumers further, as well as ease determining the
applicability of the OTC Hearing Aid Controls, we are modifying the
labeling and conditions for sale for OTC hearing aids. See Additional
Revisions 2 (section III.D.3) and 4 (section III.G), respectively, for
further explanation.
Although the technical specifications are different for OTC hearing
aids and prescription hearing aids, as explained elsewhere in this
document, FDA believes the technical specifications for each category
are appropriate. Additionally, information on the technical
specifications is required to be provided in the device labeling. FDA
believes that OTC hearing aids that comply with Sec. 800.30 and other
applicable requirements (for example, Quality System requirements) will
have reasonable assurance of safety and effectiveness for people aged
18 and older with perceived mild to moderate hearing impairment.
(Comment 19) A comment suggested that the definition of ``hearing
aid'' should include an explicit statement that PSAPs are not hearing
aids. The comment mentioned the draft guidance we are finalizing
concurrently with this final rule, ``Regulatory Requirements for
Hearing Aid Devices and Personal Sound Amplification Products,'' which
is published elsewhere in this issue of the Federal Register and is
also available at: <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/regulatory-requirements-hearing-aid-devices-and-personal-sound-amplification-products">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/regulatory-requirements-hearing-aid-devices-and-personal-sound-amplification-products</a>, and characterized the draft of
the guidance as ``provid[ing] essential distinctions between [hearing
aids] and PSAPs.''
(Response) FDA agrees that distinguishing between hearing aids
(devices) and PSAPs (non-devices) can be an important interest for
purchasers, manufacturers, and other stakeholders. We are finalizing
requirements for the principal display panel on the package of an OTC
hearing aid to bear the marks ``OTC'' and ``hearing aid'' (see
Additional Revision 2 in section III.D.3). We are also finalizing a
corresponding condition for sale that sellers may only make a hearing
aid available OTC when its package bears the requisite marks (see
Additional Revision 4 in section III.G). Moreover, we are finalizing
the aforementioned draft guidance document, intended to describe
hearing aids, PSAPs, their respective intended uses, and the regulatory
requirements that apply to both types of products.

[[Page 50710]]

We are not, however, modifying the definition of ``hearing aid'' to
state that PSAPs are not hearing aids. As we explained in the proposed
rule, the name of a product on its own would not ordinarily demonstrate
intended use (86 FR 58150 at 58154). Thus, merely excluding PSAPs from
the definition of hearing aid does not remove a product from device
regulation under the FD&C Act if, for example, its labeling
demonstrated that the product was intended to compensate for hearing
loss. We think the actions we are taking will better assist
stakeholders to distinguish between products than modifying the
definition of ``hearing aid'' in the OTC Hearing Aid Controls.
(Comment 20) Some comments suggested adding definitions to the
classification regulation for self-fitting hearing aids (Sec.
874.3325). For example, comments suggested FDA define ``programming the
hearing aid'' and ``self-fitting strategy.''
(Response) FDA is not adding definitions for purposes of the self-
fitting air-conduction hearing aid classification at this time. In
considering possible definitions to add, including those suggested in
the comments, we sought to balance clarity with flexibility. The
phrasing of Sec. 874.3325(a) is intended to cover a range of
technologies, both present and future, without unduly constraining
innovation. For example, the regulation refers to a ``self-fitting
strategy,'' rather than a more prescriptive description. Under this
regulation, manufacturers could choose different strategies to achieve
self-fitting by the user while still being substantially equivalent to
other devices of the same type. After considering the comments, we have
decided not to constrain the classification further.
However, we recognize that these commenters desired to clarify the
classification of different types of air-conduction hearing aids,
including the applicability of special controls and premarket
notification requirements. We have provided our thinking and
expectations in section V.A. of this document to address such concerns.
Further, FDA may issue guidance on this subject in the future following
our Good Guidance Practices and inviting additional comments (see 21
CFR 10.115).
(Comment 21) Several comments requested that FDA define self-
fitting hearing aids in such a way as to clarify that the devices must
be manipulable by the general public. Many of these comments showed
concern about predatory business practices, through which manufacturers
might prevent users from customizing device output, because they did
not view self-fitting capability as clearly required for OTC hearing
aids.
(Response) FDA agrees that OTC hearing aids must be somehow
manipulable by lay users; however, we are not adopting these
suggestions.
As explained in the response to Comment 1, not all OTC hearing aids
are self-fitting devices classified under Sec. 874.3325. Thus, FDA
declines to define self-fitting hearing aids in the way suggested by
comments.
Further, modifying the self-fitting hearing aid classification
regulation in the suggested way is not necessary. By definition, self-
fitting air-conduction hearing aids allow users to program their
hearing aids, and the devices integrate user input with a self-fitting
strategy and enable users to independently derive and customize their
hearing aid fitting and settings. Should users themselves be unable to
derive or customize the fitting and settings independently, or program
their hearing aids, FDA likely would not consider it a self-fitting
air-conduction hearing aid.
More generally, section 520(q)(1)(A)(iii) the FD&C Act defines an
OTC hearing aid, in part, as a device that allows the user to control
the hearing aid and customize it to the user's hearing needs. Should
users of a hearing aid be unable to control and customize the device in
the manner required, the hearing aid would not be an OTC hearing aid as
defined in the FD&C Act or final Sec. 800.30, and thus, would be a
prescription device.
FDA also notes that the FD&C Act, the OTC Hearing Aid Controls, and
the classification regulation for self-fitting air-conduction hearing
aids all refer to the ``user'' of the hearing aid. Referring to
manipulation by the general public may not accurately or adequately
represent the intended user(s) of a hearing aid because the intended
user(s) may differ in significant ways from the general population.
However, FDA agrees that manufacturers should generally assume that
users are laypeople (not experts) regarding OTC hearing aids, and we
are finalizing the definition of ``tools, tests, or software'' as
proposed. The definition specifically requires that a lay user be able
to control and customize an OTC hearing aid. Further, because OTC
hearing aids are not prescription devices (and are not otherwise exempt
from certain labeling requirements), the labeling must include adequate
directions for use, which are directions under which a layperson can
use the device safely and for its intended use(s) (see Sec. 801.5 (21
CFR 801.5)).
(Comment 22) A comment suggested that FDA explicitly require that
users have control of the device output to customize the device to
their hearing needs. This comment argued the phrasing of the definition
for ``tools, tests, or software'' that FDA proposed is ambiguous,
potentially allowing manufacturers to restrict control of the device to
physical fit but not the sound output.
(Response) As explained in the response to Comment 21, section
520(q)(1)(A)(iii) of the FD&C Act defines an OTC hearing aid as a
device that, through tools, tests, or software, allows the user to
control the hearing aid and customize it to the user's hearing needs.
In final Sec. 800.30(b), we define ``tools, tests, or software'' as
components that allow lay users to control the device and customize the
device sufficiently. As explained in the response to Comment 1, we
interpret the requirement for customization to hearing needs to mean
that the device must allow the user to cause frequency-dependent
changes based on the user's preference, and the requirement for user
control to mean that the user can access or select the output
characteristics most significant to the user's hearing perception.
These elements sufficiently describe the requisite controllability and
customization without unnecessarily constraining future technologies
that could be available OTC. We are not modifying the OTC Hearing Aid
Controls as suggested. However, as explained elsewhere in this
document, we added a user-adjustable volume control to the design
requirements for OTC hearing aids so users will be able to control this
aspect of the sound output.
(Comment 23) Comments suggested that FDA include in the definition
of ``used hearing aid'' a stipulation that a bona fide hearing aid
evaluation extend through a trial period that might last as long as 90
days. That is, a device would not be considered a ``used hearing aid''
solely because a prospective purchaser wore it for an extended trial
period, without the presence of the dispenser or a hearing health
professional selected by the dispenser.
(Response) FDA is not adopting this suggestion because purchasers
should be aware of use of the device outside of observation to ensure
appropriate operating conditions. This is because a device will be in
contact with the ultimate user's skin for extended periods, and the
device contains sensitive electronics. Without observation, a device
that a prospective

[[Page 50711]]

user is evaluating may be used in a way that would make the device
unsanitary for the ultimate user, or the device could have been
subjected to damaging conditions.
However, we are revising the definitions and labeling requirements
to clarify labeling terms to convey information better. If a
manufacturer inspects and tests a used hearing aid, makes any necessary
modifications to the hearing aid to ensure it satisfies applicable
requirements to be available OTC, including for labeling,
electroacoustic performance, and design, and the manufacturer has
adequately reprocessed the hearing aid for the next user, then the
manufacturer may describe the device as ``rebuilt'' in the required
labeling rather than ``used.''
(Comment 24) Multiple comments proposed that FDA define mild to
moderate hearing impairment in terms of objective criteria. For
example, these comments suggested that FDA adopt thresholds used by the
American Speech-Language-Hearing Association (ASHA) or the World Health
Organization (WHO) to categorize hearing impairment. Others suggested
more generally that labeling describe hearing impairment in detail so
that prospective OTC hearing aid users would ``understand exactly''
their degree of hearing impairment.
(Response) FDA is declining to define hearing impairment for
purposes of the OTC Hearing Aid Controls in terms of objective
measurements because defining hearing impairment in such a way is
neither necessary for, nor consistent with, establishing an OTC
category of hearing aids.
Inconsistency would arise because the requirements to establish the
OTC category focus on the hearing aid user's perception as well as
making devices available without the involvement of a licensed person.
Specifically, section 520(q)(1)(A)(ii) of the FD&C Act refers to
``perceived'' impairment in defining the intended use of OTC hearing
aids. As explained in the response to Comment 11, the subjective nature
of hearing impairment is integral to the regulatory category we must
establish for OTC hearing aids.
Further, an objective definition based on measurement of hearing
impairment would imply the need to involve a licensed person, such as
an audiologist or hearing instrument specialist, to administer a test
or otherwise provide an exact understanding. However, OTC hearing aids
must be available without the involvement of a licensed person (see 21
U.S.C. 360j(q)(1)(A)(v)), and FDA has determined that an objective
measurement of hearing impairment is not necessary for reasonable
assurance of safety and effectiveness of OTC hearing aids. Thus,
defining the degrees of impairment in objective terms, using one of
several available schemes for categorization, would be contrary to the
purposes of this final rule as well as unnecessary.
We acknowledge that many licensed persons use audiometric
threshold-based hearing loss categories to describe hearing loss
severity, and this information may be useful to OTC hearing aid users
should they choose to seek it out. However, the perception of hearing
difficulties is on a continuum that is not confined to specific
audiometric threshold categories. For example, two people with the same
audiometric thresholds may have different subjective perceptions of,
and different personal preferences for addressing, the impairment. The
intended user population will have a broad range of perceptual
difficulties and communicative function because of the wide variability
and overlap in perception of hearing impairment within and across
hearing loss severity.
The ASHA and WHO hearing loss categories each reflect a continuum
while providing high-level clinical guidance. These categories do not
represent discrete perceptual boundaries for the patient or for the
treating professional. Furthermore, these hearing loss categories were
not formulated to determine regulatory questions such as whether an
individual should have access to OTC hearing aids. We are declining to
adapt and apply such a scheme in that way.
Nonetheless, we are establishing labeling requirements to help
consumers recognize perceived mild to moderate hearing impairment. See
the response to Comment 35 for more on this topic. Further, the
labeling encourages users and prospective users to seek professional
services in several circumstances, and people who wish to measure their
degree of hearing impairment objectively or definitively may still
obtain such measurements voluntarily.
(Comment 25) One comment suggested that the definition of
``prescription hearing aid'' be revised to further state that these
devices are dispensed by a State-licensed professional.
(Response) FDA declines to revise the definition of ``prescription
hearing aid'' as suggested because it is unnecessary. Prescription
hearing aids are prescription devices and as such, they are subject to
Sec. 801.109. Under Sec. 801.109(a), a prescription device is a
device that is: (1) either in the possession of a person, or his agents
or employees, regularly and lawfully engaged in the manufacture,
transportation, storage, or wholesale or retail distribution of such
device or in the possession of a practitioner, such as physicians,
dentists, and veterinarians, licensed by law to use or order the use of
such device and (2) is to be sold only to or on the prescription or
other order of such practitioner for use in the course of his
professional practice. Because prescription hearing aids are required
to be in the possession of persons lawfully engaged in the retail
distribution (or certain other activities) of such devices, and must be
sold only to or on the prescription or other order of a licensed
practitioner, the revision suggested in the comment is unnecessary.
(Additional Revision 1) After further consideration, FDA is
modifying the definition of ``dispenser'' for the purposes of
prescription hearing aids under final Sec. 801.422(b). FDA proposed
that the term refer to any person engaged in the sale of prescription
hearing aids. However, we observed a potential for confusion based on
comments we received, because a person engaged in the sale of OTC
hearing aids would also be a dispenser. Thus, while the definition of
the term in Sec. 801.422(b) is for the purposes of prescription
hearing aid labeling, the definition as proposed may have appeared to
create an inconsistency with the use of the term outside of Sec.
801.422. To avoid the potential inconsistency and confusion, we are
removing ``prescription'' from the final definition of ``dispenser.''

D. Labeling (Sec. 800.30(c))

FDA received many comments related to labeling for OTC hearing
aids. Most of these comments focused on ensuring the information would
be easy to understand for most people, that is, people who are not
professionals in a field related to hearing impairment. Commenters
suggested various means to improve the labeling, including different
phrasing, formatting, or positioning. Others provided general feedback
and emphasized Plain Language principles, and a need to avoid jargon or
overly technical phrasing, to help readers understand information in
the labeling. FDA agrees that Plain Language principles apply in the
case of labeling for hearing aid users, and that Plain Language will
help users to understand the information in the device labeling.

[[Page 50712]]

1. User-Friendly Labeling
(Comment 26) Some comments expressed concern that FDA did not
validate the labeling of the OTC hearing aids. Many of these comments
are concerned that without labeling validation, a consumer's ability to
self-diagnose their hearing loss will be hindered. These comments
suggested that a requirement for manufacturers to validate labeling
will help to ensure that users can properly self-diagnose their hearing
loss.
(Response) FDA is declining to adopt labeling validation
requirements for OTC hearing aids at this time. The labeling
requirements we are finalizing benefitted from extensive input from
many sources, including docket comments and public workshops, such as
the one convened by NASEM. Additionally, self-fitting air-conduction
hearings aids under Sec. 874.3325 are subject to a special control
requiring usability testing, which inherently includes testing the
directions for use by the user. Further, any device must have labeling
bearing adequate directions for use unless subject to an exemption (see
section 502(f)(1) of the FD&C Act and Sec. 801.5). This means that the
directions for use for an OTC hearing aid must allow a lay user to use
the device safely and for its intended purposes (see Sec. 801.5).
Given these requirements, and the extensive input we have received for
labeling, a requirement for additional validation is not needed for
reasonable assurance of safety and effectiveness.
(Comment 27) Multiple comments proposed that labeling refer to an
``Ear-Nose-Throat Doctor,'' ``ENT,'' or similar terms instead of
referring to an ``ear specialist.'' These comments suggested that ``ear
specialist'' is not specific enough because it might imply somebody
besides a physician. For example, it could refer to an audiologist or a
hearing aid dispenser, neither of whom need be a physician. As such,
``ear specialist'' may confuse or inadvertently mislead hearing aid
users.
(Response) FDA agrees that ``ear-nose-throat doctor'' and ``ENT''
are more descriptive and likely more common than ``ear specialist.'' We
have revised labeling throughout to adopt this suggestion when
referring to physicians.
(Comment 28) A comment suggested that labeling refer to
``physicians'' rather than ``doctors'' because people who are not
physicians may be doctors, for example, people who hold Ph.D.s
(philosophical doctors) or chiropractors (some of whom are doctors of
chiropractic).
(Response) We are not adopting this suggestion. We are adopting
suggestions to refer to ``ear-nose-throat doctors'' instead of ``ear
specialists'' to provide better guidance to people who may be
unfamiliar with hearing healthcare delivery (see the response to
Comment 27). However, we do not expect that people will seek the
assistance of philosophical doctors or chiropractors for their hearing
needs just because the labeling for OTC hearing aids refers to a
``doctor'' rather than a ``physician.'' Instead, we expect people who
seek the assistance of a doctor for their hearing needs will exercise
reasonable judgment in discerning which kind of doctor might help them
with their hearing needs, in the same way they might exercise
reasonable judgment to find appropriate providers when suggested by OTC
labeling for other health concerns.
(Comment 29) A comment requested that ``doctor'' and ``physician''
in the labeling be revised to ``licensed healthcare practitioner.'' The
comment argued that use of ``licensed healthcare practitioner'' is
consistent with FDARA and would ensure that patients see qualified
individuals, yet not confuse and limit consumers about whom they can
consult.
(Response) FDA is declining to replace all references to ``doctor''
or ``physician'' with ``licensed healthcare practitioner'' because
there are certain aspects of hearing care where it is warranted that a
patient consult a ``doctor.'' As discussed in the response to Comment
27, FDA is updating the term ``ear specialist'' to ``ear-nose-throat
doctor (ENT)'' to avoid confusion as to whom a consumer should consult.
Where FDA now uses the term ``ENT'' it is to clarify who is best
positioned for a patient to consult on a particular matter. For
example, an ENT would generally be the kind of provider who has the
necessary qualifications and expertise to conduct an examination for
the diagnosis of Red Flag conditions. We acknowledge, however, that not
all hearing healthcare providers need to be physicians and there are
many situations, such as consumers continuing to have difficulty
hearing even after beginning use of OTC hearing aids, where consulting
licensed healthcare providers would be necessary or appropriate.
(Comment 30) A few comments recommended rewording the ``red flag''
condition warnings to present the issue first and then the solution.
Comments suggested the warning should be updated to read, ``[p]rior to
purchasing this device, if you have any of the following you should
promptly consult with a licensed physician, preferably, an Ear-Nose-
Throat (ENT) doctor.''
(Response) FDA agrees that a different presentation would more
effectively communicate the warning. In response to comments proposing
rewording to increase readability, we have retitled the warning and
reordered the introduction in the manner suggested and adopted slightly
different phrasing that we think will be more user-friendly.
(Comment 31) A comment expressed concern about the caution that
hearing aids are not hearing protection. Some comments argued that it
is impracticable for hearing aid users to take out their hearing aids
in situations where a loud sound is passing by. Comments recommended
the caution be updated to advise individuals to mute or turn off their
hearing aids when experiencing a loud sound and only recommend removal
of hearing aids if the hearing aid does not provide any hearing
protection.
(Response) FDA is declining to implement this revision. FDA has
included information in the labeling requirements to help users have
realistic expectations when using hearing aids. This particular caution
is intended to assist users in the day-to-day use of their hearing aid
and to notify them that they should not rely on their hearing aid for
hearing protection. Additionally, the labeling includes a caution that
individuals should turn down the volume or remove the device if the
sound is uncomfortably loud or painful. These two cautions provide
appropriate guidance to help ensure safety when experiencing a loud
sound.
(Comment 32) A few comments requested revisions to the note
regarding expectations about what a hearing aid can do to use more
positive framing. Comments argued that the note was more a notice of
what hearing aids cannot do, and a more positive framing would increase
readability and product desirability.
(Response) FDA agrees that it is important for users to read and
understand the labeling easily, and we have updated the note to include
language about the benefits as well as limitations of OTC hearing aids.
The language was further updated to provide notice that users may need
to wait a few weeks to get used to their hearing aids.
(Comment 33) A few comments requested that FDA require a minimum
font size so that consumers can read and understand the particulars of
each OTC hearing aid. Comments recommended requiring font sizes from
12-14 points.
(Response) FDA is declining to implement this suggestion. This rule
applies to a large number of manufacturers and their various hearing
aids so FDA believes some flexibility is

[[Page 50713]]

warranted. Additionally, we do not believe a minimum font size is
necessary to ensure users can read and understand the labeling for OTC
hearing aids because there are requirements that address this. For
example, under section 502(c) of the FD&C Act, a device is misbranded
if any word, statement, or other information required by or under
authority of the FD&C Act to appear on the label or labeling is not
prominently placed thereon with such conspicuousness and in such terms
as to render it likely to be read and understood by the ordinary
individual under customary conditions of purchase and use (see 21
U.S.C. 352(c)). Given this and other requirements, and the need for
some flexibility as the rule applies to a variety of devices, FDA does
not believe a minimum font size is warranted.
(Comment 34) A few comments recommended that the descriptions of
functions of the hearing aids include figures and videos alongside text
to provide additional clarity on how to use hearing aids.
(Response) To help users after purchase, the inside labeling must
include, among other information, a description of accessories;
illustration(s) of the OTC hearing aid that indicates operating
controls, user adjustments, and battery compartment; adequate
directions for use; technical specifications; and a description of
commonly occurring, avoidable events that could adversely affect or
damage the OTC hearing aid. The labeling requirements will allow a lay
user to use the device safely and for its intended purposes (see Sec.
801.5). The additions suggested by comments are not necessary for
reasonable assurance of safety and effectiveness.
2. User Education
(Comment 35) A comment suggested that device package labeling
describe hearing impairment in terms of common perceptual difficulties.
In specific, it proposed that labeling describe mild impairment as
having difficulty hearing soft-spoken people and young children.
According to the comment, people with mild impairment are often able to
hear loud or more-intense vowel sounds but may miss some of the softer
consonant sounds. Thus, they may have to ask people to speak up or
repeat themselves on occasion. The comment further stated that for
someone with typical hearing, this is comparable to placing a finger in
one's ears.
The comment proposed that labeling describe moderate impairment as
having additional difficulty hearing vowel sounds in addition to
missing consonant sounds. According to the comment, this means that
when someone is speaking at a normal volume, a person with moderate
hearing impairment is unable to hear most of the speech sounds.
Accordingly, people with moderate hearing impairment often comment that
they hear sounds but cannot always understand speech.
(Response) To help users determine whether they have perceived mild
to moderate hearing impairment, FDA has revised the package labeling
requirements by simplifying the language and making it less formal.
(See the response to Comment 41 for more about these revisions.)
However, while we agree that the suggested descriptions may also be
useful for prospective users, other factors impact determining the
labeling requirements. These factors include, for example, the limited
space available for the outside package labeling, as many comments
emphasized, and whether the information is necessary to provide
reasonable assurance of safety and effectiveness. The descriptions
suggested in the comment would add to the length of the material on the
outside packaging for OTC hearing aids. Additionally, the required
information under final Sec. 800.30(c)(1)(B) sufficiently helps to
provide reasonable assurance of safety and effectiveness, without the
addition of the suggested text, because it contains enough information
for someone to identify whether an OTC hearing aid may be intended for
their particular hearing impairment. Therefore, we are not revising
this final rule in the way suggested by the comment.
However, as stated above, the additional information described in
the comment may still be useful so we intend to add similar information
to FDA's website, which has pages focused on hearing aids and hearing
loss. You can access the main web page at: <a href="https://www.fda.gov/medical-devices/consumer-products/hearing-aids">https://www.fda.gov/medical-devices/consumer-products/hearing-aids</a>. You may also wish to review
information from the National Institute on Deafness and Other
Communication Disorders. You can access their web pages at: <a href="https://www.nidcd.nih.gov/health/hearing-ear-infections-deafness">https://www.nidcd.nih.gov/health/hearing-ear-infections-deafness</a>. These
websites provide more information for people interested in learning
about hearing aids and hearing loss.
(Comment 36) A few comments expressed concern that, without proper
warnings on the label, purchasers would not be informed on the
limitations of OTC hearing aids with regard to their degree of hearing
impairment.
(Response) FDA agrees and is finalizing the clear statement that we
proposed, with an updated, more user-friendly list of common symptoms
of mild to moderate hearing impairment. We are also finalizing the
requirement, with similarly improved language, that the labeling
describe signs of more severe impairment.
(Comment 37) A few comments expressed concern about the statement
that hearing aids will not restore normal hearing and that training and
counseling from a hearing healthcare professional may increase
satisfaction. Comments argued that these ideas are based upon current
limitations of hearing aids and recommended the statement be removed
because, they argued, future hearing aids may have the capability to
restore hearing to a normal level.
(Response) FDA is declining to remove this statement. The note
informs consumers of the limitations and benefits they should expect
from an OTC hearing aid. Since many purchasers will be selecting and
using OTC hearing aids without the involvement of a licensed person,
FDA has included statements, including the one discussed above, to help
consumers have realistic expectations about OTC hearing aids. This
helps provide reasonable assurance of safety and effectiveness.
(Comment 38) A few comments requested that labeling include a
warning of when to stop use of OTC hearings aids. The comments
expressed concerns that some hearing aid users may be unaware that they
should stop use of OTC hearing aids due to the onset of certain
conditions, for example, ear drainage, pain, and balance issues.
(Response) FDA agrees that certain conditions should suggest that
users consult with a hearing healthcare provider, but we do not agree
that the onset of such conditions necessarily indicates the user should
stop using OTC hearing aids. FDA has revised the labeling to make it
more general so that it warns users to see a doctor, preferably an ear-
nose-throat doctor, if the user experiences any of the listed problems
before or after purchase.
(Comment 39) A few comments recommended an additional warning on
the inside package labeling to alert individuals that there is
potential harm when wearing hearing aids for longer than recommended.
Comments proposed a warning to users to exercise special care in the
use of the device. It would warn against use of the hearing aid for
more than 12 hours a day, for example, and against use if the device
becomes uncomfortable, either due to the loudness of sound or the
physical fit of the device. Such proposed warnings sought to mitigate
the risk of further

[[Page 50714]]

impairment if the device was set to the maximum output level and worn
for periods of time exceeding these recommendations.
(Response) FDA is declining to implement such suggestions. OTC
hearing aids are designed to be worn all waking hours in a variety of
listening environments and situations. The labeling required in this
rule provides reasonable assurance of safety and effectiveness,
including through notices that the hearing aid sound output should be
neither uncomfortable nor painful, and that the hearing aid should not
cause pain or discomfort when inserting or placing it.
(Comment 40) A few comments expressed concern that the labeling
lacked reference to how a hearing healthcare professional can assist
and benefit a person purchasing an OTC hearing aid. Comments
recommended FDA develop labeling that includes guidance that, due to
their specialized knowledge, hearing healthcare professionals are
better at assisting in hearing tests and maximizing the benefits of a
hearing aid.
(Response) FDA declines to make this addition to the labeling. This
rule includes requiring specific language to assist consumers in
determining whether an OTC hearing aid best meets their needs and when
to consult a licensed professional. As mandated by FDARA, this rule
establishes requirements to provide reasonable assurance of safety and
effectiveness of OTC hearing aids without the involvement of a licensed
person; therefore, while FDA agrees that licensed professionals provide
valuable services, FDA will not be incorporating further requirements
to include additional information about the benefit of licensed
professionals in the labeling.
(Comment 41) FDA proposed that the outside package labeling include
a statement that the device may not be useful for more significant
hearing loss or complicated hearing needs. Some comments expressed
concern that the warning used ``significant hearing loss'' without
providing a definition of how to distinguish mild to moderate from
significant hearing loss. These comments suggested that FDA further
delineate mild to moderate from significant hearing loss, some of them
suggesting we use objective criteria rather than more-subjective
perceptual terms.
(Response) The final labeling requirements include the signs
suggestive of both perceived mild to moderate hearing impairment and
more significant hearing impairment. FDA included this information to
assist consumers in determining whether OTC hearing aids can meet their
needs. We have improved the phrasing of this information to be more
understandable to inexperienced hearing aid users, including by
removing the phrases the comments characterized as not defined well
enough. However, as discussed in the response to Comment 24, FDA is
declining to define hearing impairment in terms of objective criteria
for the reasons explained in that response. We are continuing to
delineate the different degrees of severity with perceptual terms as we
believe this will be most useful to the intended users.
(Comment 42) Comments expressed concern that the symptoms
suggesting perceived mild to moderate hearing impairment can also be
indications of more significant hearing loss.
(Response) FDA infers these comments are concerned that consumers
may mistake their degree of hearing loss due to the commonality of
symptoms. FDA disagrees. FDA has specified some listening scenarios
that represent some of the most common perceptual difficulties a user
with perceived mild to moderate hearing impairment may experience.
Although these symptoms may apply to multiple types and degrees of
impairments, they are most common to perceived mild to moderate hearing
impairment and therefore helpful to prospective users of OTC hearing
aids. Further, FDA is also requiring that the symptoms commonly
experienced by individuals with more significant impairment, with a
recommendation to consult with a hearing healthcare professional, be
included on the outside package labeling. Although FDA is finalizing
more user-friendly language, we are declining to modify the symptoms
for perceived mild to moderate hearing impairment. We believe that this
information, along with the information required in the labeling to
assist people with more severe impairment, will help prospective users
determine whether an OTC hearing aid is a good choice for them.
(Comment 43) A few comments suggested labeling requirements include
notice to individuals younger than 18 years old who are experiencing
hearing issues that they should visit a hearing healthcare provider
prior to using hearing aids due to complications that can cause
auditory impairment and developmental issues.
(Response) FDA agrees with the concerns expressed by these comments
and believes the labeling requirements address these concerns. For
example, the labeling requirements in the proposed rule, which are
being finalized here, include language that individuals under the age
of 18 should consult with a doctor and refrain from using OTC hearing
aids. It emphasizes the possible need for medical testing and the
potential for hearing impairment in younger people to affect speech and
learning.
(Comment 44) A few comments recommended that labeling include an
explanation on the differences between prescription hearing aids, OTC
hearing aids, and PSAPs to help consumers to select the appropriate
device.
(Response) FDA is declining to require in the labeling an
explanation of the differences between OTC hearing aids, prescription
hearing aids, and PSAPs. Although this information may be helpful to
know, it is not necessary for reasonable assurance of safety and
effectiveness of OTC or prescription hearing aids. The labeling
requirements for OTC hearing aids include common symptoms of those with
mild to moderate hearing impairment and symptoms of more significant
hearing loss to help consumers decide whether an OTC hearing aid is a
good choice for them. Further, as discussed elsewhere in this document,
prescription hearing aids must be sold only to or on the prescription
or other order of a licensed practitioner (see Sec. 801.109).
Therefore, a licensed practitioner will be involved in determining
whether a prescription hearing aid is appropriate for an individual
with hearing impairment. Additionally, FDA is issuing a guidance with
this final rule that will provide additional clarification of the
differences between hearing aids and PSAPs. The notification of
availability for the guidance appears elsewhere in this issue of the
Federal Register.
(Comment 45) A few comments requested that OTC hearing aid labeling
include a warning that people should not use OTC hearing aids if they
have tinnitus. Comments expressed concern that tinnitus can be an
indicator of serious medical conditions requiring proper management
from a hearing healthcare professional, and failure to seek immediate
treatment could cause further harm.
(Response) In the labeling requirements, FDA has included tinnitus
in one ear as a condition for which users should seek medical
evaluation. FDA is declining to expand upon this labeling requirement
to include tinnitus in both ears since bilateral tinnitus often occurs
in the presence of any degree of hearing loss. As such, the warning
would be overly broad if it were to include bilateral tinnitus.

[[Page 50715]]

(Comment 46) A few comments suggested modifying the proposed
language recommending users consult a hearing healthcare professional
if they remain concerned about their hearing or struggle to use the
device. The comments suggested that the labeling recommend users first
contact the manufacturer to allow them an opportunity to resolve any
issues.
(Response) FDA is declining to implement this suggestion. The
statement notifies users that dissatisfaction with the compensation for
impaired hearing may call for the attention of a hearing healthcare
professional. Although FDA sees the potential benefit in users
consulting with manufacturers to resolve certain technical or use
questions, the purpose of the note is not to assist with device
troubleshooting. Manufacturers may, however, include a troubleshooting
section (or similar section) in the user instructions and provide
suggestions for when users should consult them for technical or use
issues that would not necessarily call for the involvement of a hearing
healthcare professional.
(Comment 47) Some comments requested FDA require the labeling on
and/or inside the package of OTC hearing aids include information about
telecoils. Comments expressed concern that first-time hearing aid
purchasers will not be able to make informed decisions about telecoils
without an explanation of telecoil capabilities. Specific labeling
suggestions varied, but they included statements of whether the device
includes telecoils, explanations of what telecoils are, and the
benefits telecoils may provide.
(Response) FDA is declining this suggestion because not all OTC
hearing aids will have telecoils, and existing requirements would
apply, for example for adequate directions for use (see section
502(f)(1) of the FD&C Act and Sec. 801.5). (See also the response to
Comment 94 about requiring telecoils.) Including the information about
the feature could be confusing to consumers when the device does not
include telecoils. Conversely, if a hearing aid includes telecoils,
information about them would be necessary to provide adequate
directions for use, so the information would have to appear in the
labeling (see section 502(f)(1) of the FD&C Act and Sec. 801.5).
(Comment 48) Some comments requested that labeling for OTC hearing
aids include a questionnaire to assist consumers in deciding if OTC
hearing aids are appropriate for them. Comments recommended the
questionnaire to assist consumers in determining if they have a medical
condition that requires a visit to a hearing health care provider prior
to using OTC hearing aids.
(Response) FDA will not be implementing this suggestion. The
labeling requirements we are finalizing, including information on Red
Flag conditions and symptoms of more significant hearing loss, are
sufficiently informative to provide reasonable assurance of safety and
effectiveness without the additional time and effort necessary to
complete a questionnaire and assess the results for purposes of
deciding whether an OTC hearing aid is appropriate.
(Comment 49) A few comments expressed concern about the note
regarding what a hearing aid can do, which includes a statement that,
if a user has hearing loss in both ears, use of hearing aids for both
ears (bilateral hearing aids) may provide more benefit than just one
hearing aid. Comments suggested that this may discourage individuals
who wish to begin with only one hearing aid. Comments recommended
removing this paragraph from the note.
(Response) FDA disagrees that this statement would deter
individuals from using one hearing aid. This statement does not suggest
that individuals must use two hearing aids in all cases. This statement
in the note simply conveys that two OTC hearing aids may provide more
benefit in the case of hearing loss in both ears. Moreover, should
individuals with hearing loss in both ears start with one OTC hearing
aid and desire more benefit, this information would be useful to help
them understand how to achieve greater benefit.
(Comment 50) A few comments requested that the labeling include
guidance as to what to do when an eartip gets stuck in the ear canal.
(Response) FDA infers that the information requested by comments is
meant to assist users in determining when to consult a healthcare
professional. FDA agrees that providing guidance to users on this issue
is important. We have updated the labeling to help users decide when to
seek medical help (see new Sec. 800.30(c)(2)(iii)(C)).
3. Outside Package Labeling and Purchasing Decisions
(Comment 51) A few comments recommended a statement for individuals
with ability limitations, such as a developmental disability, similar
to statements directing people under the age of 18 to seek examination
and evaluation by hearing healthcare professionals. Commenters implied
that, just as with individuals under 18, individuals with ability
limitations may not have the same ability to determine their hearing
loss or the presence of more serious medical issues; therefore,
evaluation by a licensed professional would be necessary.
(Response) FDA is declining to implement this suggestion. The
statements addressed to those under age 18 concern hearing healthcare
needs that are specific to younger people, such as speech and learning
difficulties. Additionally, as explained in the proposal, the use of
OTC hearing aids in people younger than 18 presents risks to health
beyond those typically associated with use in older people. Whereas
hearing loss in older adults is most commonly related to noise exposure
and aging, the etiology (causes) of hearing loss in younger people is
varied and may result from conditions that warrant prompt diagnosis to
avoid serious risks to health (see 86 FR 58150 at 58158). The comments
provided no information to support that adults with ability limitations
face similar risks to those younger than 18.
Further, we have revised the labeling with more user-friendly terms
throughout. We believe the information required in the labeling,
including statements identifying Red Flag conditions and advising users
to consult with a hearing healthcare professional if they continue to
struggle with or remain concerned about their hearing, are appropriate
for adults with perceived mild-to-moderate hearing impairment. We do
not agree that revising the labeling or limiting purchases for certain
adults in the manner suggested by the comments is necessary to provide
reasonable assurance of safety and effectiveness of OTC hearing aids.
(Comment 52) A comment requested that FDA standardize the names of
hearing aid features so that interested people could compare products
more easily. In that vein, multiple comments suggested that FDA develop
a rating system to compare features. The commenter expressed that
information should be accessible to lay users and that relying on a
regulatory guidance document, should FDA issue one in the future, to
convey such information is unlikely to assist most consumers, who are
not experts in hearing aid technology. Similar comments desired a
rating system for device performance in certain conditions, for
example, live concerts.
(Response) FDA agrees that interested people should have sufficient
information to compare products as easily as possible, and we have made
various revisions in this final rule to

[[Page 50716]]

improve the usefulness of the required labeling for laypeople. We are
also finalizing a requirement for a conspicuous mark identifying the
hearing aid as OTC that we expect will help purchasers and others
distinguish product categories (see Additional Revision 2 in section
III.D.3). Further, FDA's website describes common hearing aid
technologies and features to help orient consumers with the technology
and terminology, available at: <a href="https://www.fda.gov/medical-devices/hearing-aids/types-hearing-aids">https://www.fda.gov/medical-devices/hearing-aids/types-hearing-aids</a>. However, we are not making additional
revisions in the final rule to standardize the names of device
features.
We note that a number of regulatory requirements will nevertheless
assist consumers to compare devices and features. For example, the
applicable classification regulation for a device specifies the name of
the device type (so is standardized in that way), and the principal
display panel on the package of an OTC device must display a statement
of identity that includes the common name of the device, in bold
typeface (see Sec. 801.61). Further, the labeling must include
adequate directions for use that allow a layperson to use the device
safely and for its intended purpose(s) (see Sec. 801.5). And for OTC
hearing aids, we proposed and are finalizing a requirement under new
Sec. 800.30(c)(4) that the labeling include certain technical
specifications. Purchasers interested in the electroacoustic
performance could use this information to compare across devices.
We acknowledge that manufacturers may use proprietary names for
device features, even when other manufacturers offer a similar feature
under a different name (perhaps also proprietary). However, FDA expects
that hearing aid technology will continue to evolve and that device
features will similarly evolve, including the specific capabilities.
Precisely identifying, describing, and naming those features and ways
to compare them by regulation, even for the present, is neither
practical nor necessary. Further, individuals may have different
preferences as to which features are more valuable in a hearing aid.
For similar reasons, a rating system is neither practical nor
necessary. Even with additional standardization of terminology, the
import of each feature may still not be apparent to purchasers, and
similarly, rating systems may not reflect (rate highly) the features of
a device that a given purchaser would value. Thus, finalizing
regulatory requirements for such a system of comparison is not likely
to communicate useful information to purchasers and may hinder
innovation by codifying current characteristics of device features.
To communicate useful information, we expect that manufacturers
will describe their devices' features in ways that best appeal to the
intended users, and the labeling of a hearing aid will have to be
available to prospective users prior to purchase (see new Sec. Sec.
800.30(c)(2) and 801.422(c)(2)). Moreover, the labeling of a device
must not be false or misleading in any particular (see 21 U.S.C.
352(a)(1)). These requirements will help ensure that purchasers have
accurate information about a hearing aid and its features in a way that
allows them to compare these devices.
As for ratings for device performance in certain conditions, given
the subjective nature of user preferences, developing a useful rating
system is impracticable. We expect that purchasers will have access to
a wealth of opinions from other purchasers, product testers or
reviewers, and consumer information organizations. This will allow
purchasers to find ratings that reflect their interests more than any
possible criteria standardized by regulation. For example, a purchaser
may prefer OTC hearing aids that users rate highly for use in a
restaurant. Additionally, user preferences may change in the future, so
any rating system may become quickly outdated.
Regarding device performance more generally, as we explained in the
proposal, we are establishing electroacoustic performance requirements
for high-fidelity amplification (see 86 FR 58150 at 58163). A hearing
aid must meet these requirements to be available OTC, but the device
need not outperform them. By extension, a device need not perform
better than a high-fidelity level of amplification. Establishing a
rating system for compliant devices, that is, for those that would
already have high fidelity, would incorrectly imply some devices are
substandard. We are not finalizing requirements for describing how well
a device performs beyond the electroacoustic performance specifications
in the labeling, the performance itself being required to meet a
standard for high fidelity.
(Comment 53) A few comments recommended that information about
whether a battery was included, and what type of battery is required,
be included on the labeling. Comments recommended the inclusion of this
information so that consumers can purchase the necessary batteries at
the same time as the OTC hearing aid and adequately compare OTC hearing
aids.
(Response) We agree that it is important for manufacturers to
include information about the type, as well as the number, of
batteries, and whether batteries are included because this is
information consumers will need to use the hearing aid. Therefore, FDA
is revising the final rule to require this information on the labeling
outside the package of the hearing aid so that consumers are aware of
the battery requirements prior to, or at the time of, purchase.
(Comment 54) A few comments recommended including a description of
any smartphone compatibility requirements to operate the hearing aid on
the outside package labeling. Comments argued this would allow
consumers to determine if they have the necessary device and
programming to operate the hearing aid prior to purchase.
(Response) FDA agrees with the comments that this information is
important for consumers to know when comparing OTC hearing aids at the
retailer. Similar to the battery information discussed above,
information on the control platform is necessary for use of the hearing
aid. Therefore, FDA is revising the final rule to require that the
outside package labeling indicate whether a mobile device or other non-
included control platform is required, such as a smartphone, a remote
sold separately, or a personal computer. The labeling also will have to
indicate the type of control platform and how the hearing aid connects
to the control platform, for example, via Bluetooth and/or USB-C.
(Comment 55) A few comments suggested that the rule require a list
of other basic features of each OTC hearing aid (for example, mobile
operating system, volume controls, feedback, telecoil, or accessories)
on the outside package. Comments expressed concern that, without a list
of features, consumers may have difficulty comparing different OTC
hearing aids and make an informed decision.
(Response) FDA is declining to implement this suggestion in its
entirety. The packaging provides limited space for required labeling,
and while we have adopted some such suggestions--see the responses to
Comment 53, about batteries, and Comment 54, about smartphone
compatibility--we have not determined that the other information is
necessary on the outside package labeling to provide reasonable
assurance of safety and effectiveness. Additionally, we are finalizing
the requirements as proposed

[[Page 50717]]

that the inside package labeling, among other requirements, provide
illustration(s) of the OTC hearing aid that indicates operating
controls, user adjustments, and the battery compartment (see Sec.
800.30(c)(2)(iv)), provide information on the function of all controls
intended for user adjustment (see Sec. 800.30(c)(2)(v)), and describe
any accessory that accompanies the OTC hearing aid (see Sec.
800.30(c)(2)(vi)). As the inside package labeling must be made
available prior to purchase (see Sec. 800.30(c)(2)), consumers will be
able to access this information prior to purchase. Further, as
discussed in the response to Comment 26, any OTC hearing aid must have
labeling that bears adequate directions for use that allow a lay user
to use the device safely and for its intended purposes (see Sec.
801.5). In cases where necessary for adequate directions for use,
information on other features not specified in Sec. 800.30(c) will
have to appear in the labeling, and prospective users will have access
to the labeling prior to purchase.
(Comment 56) Some comments expressed concerns for device labeling
that states an OTC hearing aid is ``FDA approved,'' ``FDA cleared,'' or
otherwise endorsed by the FDA. The comments asserted that such labeling
indicates that: FDA has inspected an OTC device for quality and/or
compliance with applicable legal requirements, that FDA has approved
the device for use by the individual purchaser, and/or that FDA favors
the device over others without such labeling. The comments argued that
such indications are misleading for purchasers.
(Response) FDA does not endorse particular devices and
representations of such in labeling can be false or misleading. The
determination of whether ``FDA cleared,'' ``FDA approved,'' or similar
language on a device's labeling suggests FDA endorsement of the device
or is otherwise false or misleading is made on a case-by-case basis.
Clearance of a device indicates that FDA has determined the device
to be substantially equivalent to a class I or II device. It does not
in any way denote official approval of a device or in any way imply
that the device is in compliance with any other pertinent sections of
the FD&C Act (see 41 FR 37458 at 37462, September 3, 1976). Likewise, a
grant of a De Novo classification request under 21 CFR 860.260(a)(1) or
compliance with registration and listing requirements under part 807
does not denote official approval or imply compliance with other
pertinent device requirements. Any representation that creates an
impression of official approval of a device due to complying with
requirements for premarket notification or registration is misleading
and constitutes misbranding (see Sec. Sec. 807.97 and 807.39,
respectively).
The labeling of a device may be false or misleading for other
reasons too. For example, if a statement in the labeling creates an
impression that FDA officially favors one classified device over
another, it would likely be false or misleading. Or, if the labeling
uses FDA's logo, creating an impression that FDA has endorsed the
product, it would likely be false or misleading.\8\ A device would be
deemed to be misbranded under section 502(a)(1) of the FD&C Act if its
labeling included such false or misleading statements. The FD&C Act
prohibits doing or causing certain acts with respect to a misbranded
device (see, e.g., 21 U.S.C. 331(a)-(c), (k)).
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\8\ FDA's logo is not for use on private sector materials,
including device packaging. For more information, you may wish to
review FDA's logo policy, available at: <a href="https://www.fda.gov/about-fda/website-policies/fda-logo-policy">https://www.fda.gov/about-fda/website-policies/fda-logo-policy</a>.
---------------------------------------------------------------------------

(Comment 57) A comment requested clarification on the applicability
of prescription labeling requirements under new Sec. 801.422 to the
implantable components of a bone-conduction hearing aid. The comment
argued that applying the labeling requirements to the implantable
components is unnecessary because a surgeon has already decided to
implant specific components, and the labeling under new Sec. 801.422
is neither necessary nor helpful for the surgeon or the hearing aid
user. In contrast, the non-implantable components of a bone-conduction
hearing aid, such as the sound processor, are often marketed separately
and not necessarily through a physician.
(Response) FDA agrees that the labeling requirements under Sec.
801.422 are not necessary for reasonable assurance of safety and
effectiveness with respect to the implantable components of a bone-
conduction hearing aid. We have modified the classification regulation
to clarify that the labeling requirements for prescription hearing aids
apply only to the non-implantable components of a bone-conduction
hearing aid. In cases where the implantable components are not sold or
distributed with the non-implantable components, the implantable
components need not bear the labeling under new Sec. 801.422.
(Comment 58) One comment requested that FDA strike Sec.
801.422(c)(1)(ii)(A). The comment stated that the decision to offer
trial rentals or purchase options is a trade issue and does not relate
to the safety or effectiveness of the device.
(Response) FDA has decided to retain Sec. 801.422(c)(1)(ii)(A) (in
the final rule, this information is in Sec. 801.422(c)(1)(i)(C)). FDA
notes that Sec. 801.422(c)(1)(ii)(A) does not require offering a
trial-rental or purchase-option program. Instead, this provision just
requires that the outside package labeling for a prescription hearing
aid include information advising prospective users to inquire about the
availability of a trial-rental or purchase-option program.
FDA also notes that Sec. 801.422(c)(1)(ii)(A) is substantially
identical to what was already required to be included in the user
instructional brochure for a hearing aid under former Sec.
801.420(c)(3). In other words, the information required under Sec.
801.422(c)(1)(ii)(A) is not new and has been required to be in hearing
aid labeling for many years. The only differences between Sec. Sec.
801.420(c)(3) and 801.422(c)(1)(ii)(A) are: Sec. 801.422(c)(1)(ii)(A)
applies only to prescription hearing aids, Sec. 801.422(c)(1)(ii)(A)
requires that the information be provided on the outside package
labeling for a prescription hearing aid, and the required statement
under Sec. 801.422(c)(1)(ii)(A) uses language that is easier to
understand.
FDA continues to believe that this labeling requirement is
necessary to provide reasonable assurance of safety and effectiveness
of prescription hearing aids. When FDA included the requirement in
former Sec. 801.420(c)(3) to provide information in the user
instructional brochure advising prospective users to inquire about the
availability of a trial-rental or purchase-option program, FDA
acknowledged the difficulty of determining in advance whether an
individual will benefit from a hearing aid, and we noted that voluntary
trial-rental or purchase-option programs for prospective hearing aid
users were available (42 FR 9286 at 9289).
FDA believed that trial-rental or purchase-option programs, which
provide prospective hearing aid users the opportunity to wear the
selected hearing aid so that the user can make an informed judgment on
whether a benefit is obtained from the use of the hearing aid, were
important to the welfare of the hearing impaired and therefore,
required that the user instructional brochure contain information
advising prospective users to inquire about the availability of such
program (42 FR 9286 at 9289). FDA explained that this information would
help assure that the

[[Page 50718]]

selected hearing aid would be beneficial and would encourage hearing
aid use among those prospective users who lack the motivation to try a
hearing aid because of the fear that they will spend a great deal of
money with no guarantee of benefit (42 FR 9286 at 9289). FDA believes
that the reasons for requiring this information in labeling continue to
apply for prescription hearing aids, which are typically sold through
licensed hearing aid dispensers, many of whom offer such programs.
(Additional Revision 2) In response to various concerns evident in
the comments, we are including in this final rule a requirement that
the principal display panel of the outside package labeling of an OTC
hearing aid bear the conspicuous marks, ``OTC'' and ``hearing aid.''
FDA intends these marks to clarify for purchasers and others, including
retailers and State agencies, whether a product is a hearing aid
(regulated as a device), and whether it is available OTC. (See also the
response to Comment 18 discussing hearing aid terminology.) However,
these marks do not in any way denote official approval of the device,
and any representation that creates an impression of official approval
because of complying with these marking requirements or with the OTC
Hearing Aid Controls would be considered false or misleading and
constitute misbranding. (See also the response to Comment 56 regarding
other false or misleading statements.) The marking is necessary for
reasonable assurance of safety and effectiveness of OTC hearing aids
because it provides assurances that non-OTC hearing aids or non-devices
will not be confused for OTC hearing aids.
The marks must have the same prominence as required under Sec.
801.61(c) for the device's statement of identity, and a manufacturer
may satisfy this new marking requirement if the statement of the
device's common name includes both ``OTC'' and ``hearing aid.'' For
example, a manufacturer may label its product as a ``Self-Fitting OTC
Hearing Aid'' (assuming the device's common name is ``self-fitting
hearing aid''). Such a device would meet this new marking requirement
as well as the requirement for the common name in the statement of
identity. Alternatively, the manufacturer may, for example, label its
product without including the marks in the common name of the device,
perhaps by placing ``OTC'' in a corner of the principal display panel
with the required prominence (assuming the device's common name
includes ``hearing aid''). Formatting the marks, for example, by
outlining them with a box, would be permissible provided the formatting
does not cause the marks to lack the required prominence (see 21 CFR
801.15(a)(6)).
4. Labeling Inside the Package and Technical Matters
(Comment 59) A few comments requested that the frequency response
and ANSI S3.22 specifications of OTC hearing aids be included in the
user manual.
(Response) FDA infers this request is to assist in selecting an OTC
hearing aid with optimal performance. We are not requiring the
requested information in OTC hearing aid labeling because, as we
explained in the proposal, this information is highly technical and
generally not useful to the lay user (see 86 FR 58150 at 58163).
However, we are finalizing the proposed requirement that OTC hearing
aid labeling include key electroacoustic performance specifications
that are more likely to assist prospective lay users in comparing and
selecting the devices, including the values for maximum output, full-on
gain, total harmonic distortion, self-generated noise, latency, and
upper and lower cutoff frequencies for the acoustic bandwidth.
(Comment 60) A few comments expressed concern that requiring
summaries of clinical studies conducted by or for the manufacturer on
the inside labeling is not practical. Comments suggested that providing
a link to an online library of the clinical studies and a summary of
each study on the manufacturer's website would suffice.
(Response) FDA disagrees that providing summaries of clinical
studies in the labeling inside the package is impractical. While we
understand that fully appreciating the outcomes of a study can entail a
lengthy technical document, presenting the most important findings
regarding the performance of the OTC hearing aid, in a user-friendly
format, need not take significant space in the labeling. We are
finalizing the requirement as proposed.
(Comment 61) A few comments requested that the labeling include
information on how the OTC hearing aid can be fixed or repaired.
Comments requested that the information include whether a local hearing
healthcare professional can repair the device or if it needs to be sent
to the manufacturer. Comments argued this would allow prospective users
to make an informed decision when purchasing their devices.
(Response) FDA agrees that manufacturers should provide users with
information on how to have their hearing aid repaired because this
information may be difficult for users to obtain on their own. The
inside package labeling requirements now include information on how and
where to obtain repair service or replacements, with at least one
specific address where the user can go or send the OTC hearing aid to
obtain such repair service or replacements.
(Comment 62) A few comments expressed concern that estimating the
expected battery life will be difficult for manufacturers due to
inconsistencies between batteries and use conditions. Comments proposed
removing this requirement from the labeling inside the package.
(Response) FDA recognizes that battery performance can vary but
will retain this requirement in the final rule because this information
will help prospective purchasers determine whether a hearing aid will
be suitable for their circumstances. Recognizing that performance can
vary from device to device, we did not propose, and are not requiring,
a specific method of estimating the battery life. However,
manufacturers may want to review Clause 4.7 (Battery Life) of ANSI/CTA-
2051:2017, which currently provides an acceptable method to estimate
the battery life (Ref. 8).
(Comment 63) A comment proposed a requirement for OTC hearing aid
labeling to include information about the transport methods for
configuration information and other data to and from the OTC hearing
aid with all points along the supply chain.
(Response) FDA is not adopting this proposal because such
information is focused on the electronic transfer of non-diagnostic
data and is not generally necessary for reasonable assurance of safety
and effectiveness of all OTC hearing aids. We note, however, that
should States establish or continue in effect requirements to disclose
such information, and the requirements are not specifically applicable
to hearing products, section 709(b)(4) of FDARA likely would not
preempt them. However, FDA is not opining on whether such disclosure
requirements likely would or would not be preempted under section
521(a) of the FD&C Act. (See also the response to Comment 115
concerning the collection of personal information as part of a sale of
an OTC hearing aid.)
(Comment 64) A comment requested that FDA require labeling that
specifies the latency of any wireless streaming technologies the OTC
hearing aid uses.
(Response) In certain circumstances, latency information in the
labeling may be necessary under existing requirements. For example, if
the information is necessary to provide adequate directions for use or
necessary

[[Page 50719]]

for practitioners licensed by law to use the device safely and for its
intended purpose(s), then the latency information would have to appear
in the device labeling (see Sec. Sec. 801.5 and 801.109(c),
respectively).
However, as a general matter for hearing aids that incorporate
wireless streaming technology, FDA has determined that stating the
streaming latency is not necessary to provide reasonable assurance of
safety and effectiveness. Additionally, a variety of factors can affect
wireless streaming latency, including nearby radio interference,
distance between the transmitter and receiver, and the presence of
materials that absorb certain radiofrequencies. As such, a standardized
wireless streaming latency value may not reflect a particular device's
design or the environment in which the user wears the hearing aid; and
thus, FDA is not adding a requirement to include wireless streaming
latency information for all OTC hearing aids in this rule. We note that
FDA is finalizing requirements for OTC hearing aid labeling to include
manufacturer contact information. If users or prospective users are
interested in the streaming latency specifically, they will be able to
contact the manufacturer.
(Comment 65) A few comments requested a labeling requirement
describing the fitting range across different frequencies (500, 1000,
2000, and 4000 Hertz) to help consumers determine the suitability of
different OTC hearing aids to meet their needs.
(Response) FDA understands that traditionally, hearing aids are
designed and marketed with a specific fitting range in mind, and
manufacturers may maintain this practice. However, OTC hearing aids are
intended to be available without the involvement of a licensed person
(see 21 U.S.C. 360j(q)(1)(A)(v)). As such, FDA is not using audiometry-
defined thresholds or ranges of hearing loss in the final rule.
Instead, FDA is using descriptions of common symptoms of mild to
moderate hearing impairment in the labeling. As such, describing the
fitting ranges across different frequency bands is not necessary for
reasonable assurance of safety and effectiveness of OTC hearing aids.
However, manufacturers may choose to include this information in device
labeling, and prospective users will have access to the manufacturer's
contact information prior to purchase should they desire to inquire
about the fitting ranges.
5. Adverse Event Reporting
(Comment 66) The proposed labeling included instructions on
reporting adverse events through the MedWatch portal, <a href="https://www.fda.gov/Safety/Medwatch">https://www.fda.gov/Safety/Medwatch</a>, or by phone, 1-800-FDA-1088. A few
comments requested that email and mailing options also be provided for
adverse event reporting. Comments further recommended that FDA provide
a receipt of the complaint to individuals.
(Response) We are declining to include a mailing address in the
labeling because submissions by mail should be on a MedWatch form, for
example, the Consumer Voluntary Reporting Form (FDA 3500B), which
contains the address along with additional instructions. Reference to
just the address in hearing aid labeling may result in reports
submitted in an unexpected manner and format, potentially causing
confusion, incomplete reports, and significant delays in processing
them. However, in addition to reporting events through the MedWatch
portal and 1-800-FDA-1088, consumers can submit their adverse event
reporting form to FDA by fax or the mailing address according to the
instructions on the form. Submitters will receive a reply from FDA
after we receive their report. Email is not currently an alternative to
the MedWatch online submission system.
(Comment 67) A few comments recommended that in addition to
labeling information on reporting adverse events to FDA, contact
information for manufacturers should be required so that manufacturers
are provided the opportunity to review adverse events. Comments implied
that providing manufacturers with awareness about adverse events and
opportunity to address them would be beneficial to consumers.
(Response) To help facilitate communications between users and
manufacturers, FDA has added the manufacturer's email and mailing
address to the labeling requirements (see final Sec.
800.30(c)(1)(i)(E)). Should users wish to report adverse events to the
manufacturer, they may use this information to do so. Manufacturers may
also include instructions in the labeling, that do not conflict with
the labeling requirements, on how to directly report adverse events to
them.
(Comment 68) FDA included in the proposed labeling examples of
adverse events to be reported to FDA: irritation of the ear canal or
outer ear skin, injury from the device (like cuts or scratches, or
burns from an overheated battery), pieces of the device getting lodged
in the ear canal, and sudden increased severity in hearing loss with
the device. Some commenters suggested limiting the list to more-serious
conditions to avoid the adverse reporting system being overwhelmed by
reports of minor adverse events. Commenters expressed concern that if
the labeling were finalized as proposed, more serious adverse events
may get lost in the volume of what the commenters see as minor.
Commenters recommended adverse event reporting be limited to
significant injury and/or death.
(Response) FDA is declining to limit the examples of adverse
events, or the reporting of adverse events, to significant injury and/
or death. FDA is interested in receiving information on all adverse
events to have a better understanding of OTC hearing aid product safety
and performance. Additionally, under section 709(d) of FDARA, FDA is
required to submit a report to Congress ``analyzing any adverse events
related to over-the-counter hearing aids.'' FDA is prepared to review
adverse event reports and has experience in sorting through adverse
event reporting data to identify safety signals and trends.
(Comment 69) Comments requested that users of prescription hearing
aids be able to report adverse events to FDA similar to how OTC hearing
aid users can report through the MedWatch portal at <a href="https://www.fda.gov/Safety/Medwatch">https://www.fda.gov/Safety/Medwatch</a>, or by phone, 1-800-FDA-1088.
(Response) We agree that prescription hearing aid users should also
report adverse events to FDA. We proposed and are finalizing the same
note for prescription hearing aids to notify users of how to report
adverse events to FDA.
6. Miscellaneous Labeling Considerations
(Comment 70) Some comments recommended that restrictions on the use
of OTC hearing aids by individuals under the age of 18 be removed.
Comments expressed the need for cost effective hearing aids for
individuals under 18. Additionally, comments asserted that individuals
under 18 are increasingly suffering from hearing loss as a result of
exposure to loud sounds, which they argued is hearing loss that can be
addressed by OTC hearing aids.
(Response) FDA is declining to allow the sale of OTC hearing aids
to individuals under the age of 18. This condition for sale is
consistent with section 709(b)(2)(C) of FDARA and section
520(q)(1)(A)(ii) of the FD&C Act, which establish that OTC hearing aids
are only intended for people aged 18 and older. The use of OTC hearing
aids

[[Page 50720]]

in people younger than 18 presents risks to health beyond those
typically associated with use in older people. While FDA appreciates
the need for cost effective hearing aids for individuals under the age
of 18, the sale of OTC hearing aids will be limited to individuals who
are age 18 and older.
(Comment 71) A few comments expressed concern that the manufacturer
contact information that FDA proposed to include in the labeling of OTC
hearing aids is limiting because the only alternative to a website
address was a telephone number. Comments argued that many individuals
with hearing loss do not prefer to communicate using the telephone and
recommended the inclusion of the manufacturer's email and mailing
address on labeling to provide greater access to users.
(Response) FDA agrees that providing additional ways for users to
communicate with manufacturers will allow for users to resolve issues
with their hearing aids more easily. The labeling requirements have
been updated to include the manufacturer's mailing address and email
address.
(Comment 72) A few comments noted that hearing aids are physically
small and do not have room for a serial number on them. Comments
recommended that the serial number be located on an accompanying item,
such as on the storage case or registration card.
(Response) FDA is declining to implement this suggestion.
Manufacturers have been complying with this long-standing requirement
for labeling under Sec. 801.420, which we are revising and renumbering
as Sec. 801.422, and marking the serial number on the device itself
(since 1977). Additionally, because accompanying items can be
misplaced, marking the device itself is essential to the utility of the
serial number.
(Additional Revision 3) As noted in the response to Comment 8, we
are finalizing labeling requirements for hearing aid software. We
expect much of the labeling to be electronic in nature, for example,
the graphic and printed matter that appear on a download web page or in
electronic display ``cards'' or dialogs in the software's user
interface. As such, electronic labeling may have a transitory nature,
and we are specifying the occasion and persistence of presentation. For
example, we are requiring that the labeling present a warning against
use in people younger than 18. In this example, the electronic
labeling, perhaps appearing in a modal dialog, need not appear at all
times. Rather, we are requiring that the labeling present the warning
to the user prior to first use of the software and persist until the
user acknowledges it. We are further requiring that the software
provide access to all of its labeling for later review, for example,
through a Help menu selection.
We intend the software device labeling requirements to correspond
with the labeling requirements we proposed for packaged hearing aids to
the greatest extent possible. As such, we are requiring that the
software device labeling present certain information prior to first use
or obtaining payment information for the software (not necessarily the
hearing aid or amplification platform), reflective of the nature of the
information we are requiring on the packaging, that is, information the
prospective user should know prior to purchase, if a purchase is
involved. Some labeling is required prior to first use, but it could
appear after purchase of the software, if a purchase is involved. Other
labeling is required to be accessible in the software, but it need not
be presented at any particular time.
We recognize that some of the information required in the labeling
under final Sec. 800.30(c)(1) through (4) may not apply to software.
For example, specific instructions for cleaning and disinfection likely
would not apply to stand-alone software (see final Sec.
800.30(c)(2)(vii)(D)). As another example, an illustration of the
battery compartment likely would not apply (see final Sec.
800.30(c)(2)(iv)). To address this, we made it clear that certain
information is required to the extent applicable. Thus, in the first
example, the software device labeling need not include instructions for
cleaning and disinfection if that information is not applicable. In the
second example, the software device labeling must include an
illustration(s), but not necessarily of the battery compartment if not
applicable. Further, in that example, a video would be an adaptation of
and suffice for an illustration(s). Although software may not have a
principal display panel like a packaged hearing aid, a software-loading
or Home screen could serve a similar function to provide the
information required under Sec. 800.30(c)(1)(iii).
We have also included requirements for the software device labeling
to disclose compatibility requirements as well as any fees or payments.
Disclosure of compatibility requirements is necessary for reasonable
assurance of safety and effectiveness because this information
describes some of the necessary conditions under which the software
device will be usable and thus safe and effective. The disclosures of
any fees or payments are similarly necessary because they describe
necessary conditions under which the software or additional features
will start, continue, and/or cease to operate safely and effectively.
The software labeling requirements we are finalizing under new
Sec. 800.30(c)(5) are in addition to any other applicable requirement,
including special controls. For example, 21 CFR 801.50, regarding
labeling requirements for stand-alone software, would still apply to
the software when appropriate under that regulation. As another
example, the general requirements for adequate directions for use (see
section 502(f)(1) of the FD&C Act and Sec. 801.5) would also apply,
unless the software device is exempt under Sec. 801.109.
We are adding similar software device labeling requirements in
Sec. 801.422.

E. Output Limits (Sec. 800.30(d))

Generally, comments on the output limits for OTC hearing aids
either agreed that FDA's proposed limits were appropriate or comments
proposed lower limits. Several comments recommended output limits that
depend on device design, for example volume control, compression, or a
limit on gain. FDA received many comments on this subject, some of
which included references to published scientific literature, consensus
standards, stakeholder position papers, and public health guidelines.
For the following reasons, we are finalizing lower output limits than
we proposed--111 and 117 dB SPL, which are multiples of 3-dB reductions
from the proposal--but we are not including a separate gain limit.
1. Finalizing Lower Output Limits
After further considering the potential risk of worsening users'
hearing impairments as discussed below, as well as the literature
submitted to us in the comments (e.g., Refs. 10 and 11), we have
decided to finalize lower output limits than we proposed. We are
retaining the conditional structure of the output limits, with the
higher output permitted for devices with activated input-controlled
compression. (See the response to Comment 87 about requiring a user-
adjustable volume control for all OTC hearing aids.) We are also
retaining the limits expressed as Output Sound Pressure Level 90
(OSPL90) values rather than A-weighted values as suggested by some
comments. OSPL90 values are more common expressions of hearing aid
outputs, and they are consistent with the consensus standards we are
adopting, which refer to OSPL90 values.

[[Page 50721]]

Comments suggested a variety of lower limits, but we are adopting a
general limit of 111 dB SPL, which is sufficient to mitigate the
greater risk potential from both acute high-output-levels and
cumulative exposure that we identified after further consideration. We
are correspondingly finalizing the higher conditional limit of 117 dB
SPL for devices with activated input-controlled compression.
Many commenters suggested an output limit of 110 dB SPL and
considered this output limit sufficient to address even moderate
impairment, as each commenter defined the term ``moderate.'' However,
as discussed further below, we have applied an equal-energy principle
and used a 3-dB exchange rate in revising the general output limit to
111 dB SPL. We do not believe that an output limit of 110 dB SPL would
provide any meaningful difference with regard to safety.
The output limits that we are finalizing balance safety and
effectiveness without unduly sacrificing either. We are not adopting
the even lower limits suggested in some comments because these lower
limits would reduce device effectiveness for people with perceived mild
to moderate hearing impairment to such a degree that the limits would
exclude some intended users from obtaining sufficient benefit of OTC
hearing aids. At the same time, progressively lower output limits yield
diminishing returns in terms of safety. Thus, lowering the output limit
even further as suggested in some comments would begin excluding
intended users without achieving meaningful improvements in safety for
them. As a result, lowering the output limits even further as suggested
in some comments would not provide reasonable assurance of
effectiveness for people with perceived mild to moderate hearing
impairment, and thus would not be ``appropriate'' for OTC hearing aids
per section 709(b)(2)(B) of FDARA.
The reduction in effectiveness and benefit would result primarily
because, with even lower output limits, the hearing aid would no longer
have a sufficient dynamic range (``headroom'') for high-fidelity
amplification. The hearing aid could then apply compression and/or
other output limiting measures more often or to a greater degree,
resulting in perceptibly lower-fidelity (less effective) amplification.
In such circumstances, OTC hearing aids would have significantly
reduced effectiveness for the intended users, sometimes even in
normally non-hazardous environments. This reduction in effectiveness
would be increasingly noticeable for intended users as the device
output is reduced.
By way of comparison, a comment urging FDA to adopt an output limit
of 102 dB SPL also urged FDA to limit the intended users of OTC hearing
aids to people with mild impairment rather than mild to moderate
impairment. As we explain in the response to Comment 10, we are not so
limiting the OTC category, and an output limit that low would not
provide reasonable assurance of safety and effectiveness in addressing
perceived mild to moderate hearing impairment. As provided in section
520(q)(1)(A)(ii) of the FD&C Act, OTC hearing aids are ``intended to be
used by adults age 18 and older to compensate for perceived mild to
moderate hearing impairment.''
Moreover, many comments urging FDA to adopt lower limits than the
ones we are finalizing referred to material that stated output levels
in root mean square (RMS) terms. The limits we are finalizing are
expressed differently--expressed in terms of maximum peak values
(implicit in the measurement of OSPL90 values). To derive a peak value
based on an RMS level, one would increase the RMS level by an amount
that represents the ``crest factor'' of the output. Thus, except in one
circumstance that is not applicable to the materials submitted to us,
RMS values are lower than peak values for the purposes of considering
the sound output of hearing aids, and comparisons between RMS and peak
values need to take this difference into account.\9\
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\9\ For square wave signals, the peak and RMS values would be
the same (a 0-dB difference). However, for the purposes of
describing hearing aid performance, a crest factor would be an
important element for considering limits as RMS values, for example,
to ensure a limit expressed as an RMS value allowed for effective
amplification of speech. Crest factors for speech are often 12-17
dB, with 15 dB being a value frequently cited in comments.
---------------------------------------------------------------------------

As noted, we are also finalizing a lower limit for OTC hearing aids
with input-controlled compression activated. This value, 117 dB SPL, is
intended to maximize the available headroom for OTC hearing aids while
still providing reasonable assurance of safety and effectiveness. As we
explained in the proposal, input-controlled compression is an automatic
function that dynamically reduces the device's output and helps prevent
the device from continuously performing at its output limit (see 86 FR
58150 at 58161-58162). In these ways, the use of input-controlled
compression adequately addresses the safety concerns that the increased
output can raise. We explain our reasons for finalizing lower output
limits in more detail below.
We wish to emphasize that, in finalizing lower output limits, we do
not intend to reduce the number of intended users for whom the use of
OTC hearing aids is safe and effective (in comparison to the proposed
limits). Rather, we are lowering final limits to allow sufficient
headroom for the same intended users, albeit less headroom than we
proposed. As stated above, the output limits that we are finalizing are
intended to balance safety and effectiveness without unduly sacrificing
either.
In response to comments, we are also revising the final regulation
to permit the use of alternative acoustic couplers when a 2-cubic
centimeter (cm\3\) coupler is not compatible with the device design.
See the response to Comment 81 for more on this topic.
Additionally, we are slightly modifying the phrasing of the
regulation to clarify that the device may reach the higher limit only
while the input-controlled compression is activated. For example, if a
user were to deactivate the feature, the device must not exceed the
general output limit of 111 dB SPL while the feature is deactivated.
2. Considerations for Appropriateness of Output Limits
In deciding to finalize lower output limits, FDA is primarily
considering output limits that will provide reasonable assurance of
safety and effectiveness and are ``appropriate'' for OTC hearing aids
as section 709(b)(2)(B) of FDARA uses the term. To determine such
limits, we are balancing considerations of safety and effectiveness for
all intended users of these devices to both protect and promote the
public health. As we explained in the proposed rule, too high of an
output can be unsafe (see 86 FR 58150 at 58161). However, too low of an
output reduces device effectiveness and can lead to poor device
performance, and ultimately, can reduce satisfaction and use (see 86 FR
58150 at 58161).
Many comments described the communication needs of hearing aid
users and how those interests relate to the output limits and the
purposes of establishing the OTC category of hearing aids. FDA agrees
that those interests are relevant to safety and effectiveness as well
as what would be appropriate. However, balancing the various
considerations related to safety and effectiveness is complex and
involves the application of scientific judgment. Thus, while FDA agrees
with the many thoughtful comments that several factors, discussed
further in this section, affect the determination of appropriate output
limits, we do not always agree

[[Page 50722]]

with the determination reached by commenters.
One of the purposes of this rulemaking is to address a widespread
public health need stemming from relatively low adoption and use of
hearing aids by people who could benefit from them. More specifically,
an underlying goal of this rulemaking is broadening access to these
devices, without the involvement of a licensed person, to compensate
for perceived mild to moderate hearing impairment in adults. (See the
responses to Comments 10-12 for more about the scope of this
rulemaking.) FDA is mindful of the need to establish or adopt output
limits that would provide sufficient amplification to meet the user's
listening needs and thereby bolster user satisfaction, adoption, and
use. Moreover, OTC hearing aids need a sufficient output, maximizing
the available dynamic range (the headroom), to meet the hearing needs
of the breadth of the intended population of adults with perceived mild
to moderate hearing impairment. Therefore, the output limits must not
be too low.
The appropriateness of output limits for OTC hearing aids should
also account for circumstances in which users must determine for
themselves when amplification may be excessive and then potentially
take action to mitigate or avoid the situation, without the involvement
of a licensed person for training or intervention. We are aware that
some users of hearing aids who have perceived mild to moderate
impairment may have difficulties with such tasks. For example, they may
have reduced dexterity or may have difficulty judging their listening
environments. Thus, we are also mindful of the need to establish or
adopt output limits that provide for reasonable assurance of safety and
effectiveness for such users and others. Therefore, the output limits
must not be too high. (See also the response to Comment 100 regarding
the use of consensus standards.)
FDA has considered quantitative information to inform our
consideration of safety and effectiveness. In the proposed rule, we
referred to a national workplace safety guideline, ``Occupational Noise
Exposure,'' developed by the National Institute for Occupational Safety
and Health (NIOSH) (see 86 FR 58150 at 58161-62) (Ref. 9). That
guideline, which we will refer to as NIOSH-98, defines, among other
subjects, hazardous levels of sound exposure in relation to the
duration of exposure. It uses as its basis 85 dBA (A-weighted decibels)
over 8 hours (as in, a generic workday) as the maximum non-hazardous
exposure level (see paragraph 1.1 of NIOSH-98). Roughly speaking, the
difference between A-weighted decibels and decibels of sound pressure
level, for present purposes, is about 5 dB. As such, 120 dB SPL, or
about 115 dBA, of exposure over 28 seconds would be equivalent to a
full workday's allowable exposure for purposes of occupational safety
(see table 1-1 of NIOSH-98). To address different levels of exposure
besides 85 dBA, NIOSH-98 uses a 3-dB exchange rate (or equal-energy
rule), meaning that the allowable time before the exposure is
considered hazardous halves for every 3-dB increase (see paragraph
1.1.2 of NIOSH-98). In other words, for louder exposures, NIOSH-98
indicates less allowable time than 8 hours and vice versa for lower
exposures.
We have applied an equal-energy principle and used a 3-dB exchange
rate as a basis for revising the output limits. This interval, rather
than another amount, more clearly reflects our consideration of non-
hazardous outputs and the differing output levels. Thus, 117 dB SPL,
which is 3 dB less than proposed, represents half the output power of
the proposal or twice the time to achieve the same cumulative exposure
(when the hearing aid is outputting at the limit). This translates to a
lower risk of impairment from using OTC hearing aids. However, half the
allowable power does not mean the output will sound ``half as loud.''
As such, not only does 117 dB SPL translate to a lower risk, it also
does not unduly sacrifice effectiveness.
For the purpose of illustration, you might think of a person as
having a ``budget'' of allowable sound exposure from a hearing aid to
avoid further hearing impairment. The rate at which the person goes
through the budget depends on the output level, and higher outputs
(which have higher power) will use up the budget faster than lower
outputs. In other words, because outputs at 117 dB SPL are half the
power of those at 120 dB SPL, 117 dB SPL will use up the sound budget
more slowly. If a hearing aid user encounters a sound at 117 dB SPL
while using hearing aids, the user will thus have more of the budget
left over to continue wearing the hearing aid for the rest of the day
(without over-exposure) than if the loud sound were at 120 dB SPL.
Note, however, that this analogy is merely an illustration of some
concepts of cumulative exposure. Hearing healthcare professionals use
more technical and precise concepts to describe the effects of sound
exposure on hearing abilities.
FDA notes that nothing in this rulemaking is intended to interpret
the application of NIOSH-98 for purposes of occupational exposure.
Rather, we are considering the effects of cumulative and ongoing
exposure in relation to equivalent peak output levels for the purposes
of this rulemaking. Conversely, we wish to clarify that referring to
NIOSH-98 does not mean that hearing aids should offer an output
comparable to occupational noise exposure. (The sound output of a
hearing aid is unlikely to reach its output limit regularly.)
Nonetheless, NIOSH-98 provides a well-reasoned quantitative approach to
the effects of sound exposure on people's hearing.
While many comments agreed that FDA's proposed output limits
provided an adequate safety margin, other comments disagreed and called
our attention to scenarios in which sound exposure at a relatively high
level might be followed by continuing exposure at a relatively modest
level. In certain circumstances, the equal-energy principle would imply
that the relatively modest exposure could nevertheless be hazardous. In
the proposed rule, we used the 3-dB exchange rate to compare the
presumable reaction times between 120 dB SPL and 115 dB SPL, explaining
that the latter offers about triple the time, an additional 61 seconds
(approximately), given the 5-dB difference (see 86 FR 58150 at 58161).
This does not imply that a continuous sound output of 115 dB SPL is
safe for an extended period of use of an OTC hearing aid. This also
does not imply that the user has approximately 89 seconds to intervene
(for example, to remove the OTC hearing aid). Experiencing these output
levels for long-enough periods of time could place the user at greater
risk for further hearing impairment even though the user might judge
the follow-on exposures to be modest or normal.
We acknowledge that the statement in ANSI/CTA-2051:2017 that 115
dBA (about 120 dB SPL) is an acceptable listening level for up to 30
seconds might imply that repeated exposures to 115 dBA (about 120 dB
SPL) over the course of a day's use of a hearing aid are necessarily
acceptable as long as the exposures are shorter than 30 seconds. (Note
that a day's use of a hearing aid may be longer or shorter than the
generic 8-hour workday that NIOSH-98 uses.) Further, we recognize that
referring to the full time as a safety margin did not adequately
account for exposure to other sounds throughout the day because using
the entire 28-second interval would equate to a day's worth of
allowable cumulative exposure. The

[[Page 50723]]

28-second interval assumes no other sound exposure during that 8-hour
timeframe rather than continuing use (and exposure) at a low-enough
level. In consideration of the comments, especially those calling our
attention to possible scenarios leading to excess cumulative exposure,
we have determined we should reduce the risks of cumulative exposure
and do so by finalizing lower output limits than proposed.
Nevertheless, FDA does not expect OTC hearing aids to perform at or
near their maximum output capabilities for extended periods of time
during the day, if at all. As such, neither our reference to NIOSH-98
nor to ANSI/CTA-2051:2017 should be read to imply that constant outputs
at or near 115 dB SPL (about 110 dBA) are necessarily safe. Instead,
the limits we are finalizing are meant to be high enough to allow
sufficient headroom for high-fidelity amplification for people with
perceived mild to moderate hearing impairment, including amplification
of occasional peaks necessary to reproduce certain kinds of higher
intensity, but infrequent, sounds (see 86 FR 58150 at 58161-62).\10\
However, a device's design or software may have sufficient headroom
without reaching the maximum allowable output. We intend these output
limits to facilitate wide adoption of hearing aids and design
flexibility without being unnecessarily prescriptive.
---------------------------------------------------------------------------

\10\ The maximum output for a person with greater hearing
impairment is likely to be higher than for a person with less
impairment; however, this general rule is subject to considerable
individual variability.
---------------------------------------------------------------------------

Some comments recommended that FDA adopt a requirement for
dosimetry, in essence applying similar principles as those described in
NIOSH-98. That is, they suggested that FDA require that OTC hearing
aids be able to measure the weekly sound exposure from the use of the
device. Instead of limiting peak output, the devices could then limit
exposure to a safe cumulative dose. While this approach may be one way
to limit exposure, insufficient scientific data exist regarding
cumulative exposure with the use of hearing aids by people with
perceived mild to moderate hearing impairment. Moreover, as we noted
above, this rulemaking and NIOSH-98 contemplate very different
contexts, so the quantitative information cannot be directly applied to
determining cumulative output limits appropriate for OTC hearing aids.
In sum, FDA believes that establishing a dosimetry-based limit for
regulatory purposes would be scientifically premature at this time.
Indeed, quantitative analyses of safe maximum output limits are
generally difficult to apply because the data do not necessarily
reflect regulatory considerations. For example, they do not fully
reflect the intended users, specifically users with perceived mild to
moderate hearing impairment, or other considerations for reasonable
assurance of safety and effectiveness of OTC hearing aids. Some sources
use audiometric threshold-based analyses to quantitatively predict safe
maximum output limits (e.g., Ref. 10). However, such analyses use
criteria that FDA is not adopting as they have the effect of excluding
some people for whom OTC hearing aids would be appropriate. Other
references use threshold-based analyses for the maximum output for a
hearing aid that is programmed using existing professional fitting
formulas, applied to a database of audiograms (e.g., Ref. 11). These
results, however, do not fully reflect the intended users of OTC
hearing aids, and interpreting the results often involves the
application of criteria that FDA is not adopting, for example, the
choice and application of threshold-based hearing loss categories.
In either case, these findings are limited for identifying
appropriate output limits for OTC hearing aids because this rulemaking
is intended to address perceived, not audiometrically quantified,
impairment. (See also the response to Comment 24 regarding measurements
of hearing loss and incorporating numerical thresholds into this
rulemaking.) Moreover, different commenters interpreted the same
references differently, demonstrating that even quantitative analyses
leave much to interpretation. Well-reasoned, scientific views still
exhibited significant diversity. The analyses are instructive, and we
have updated our risk assessment based in part on them, but they cannot
definitively settle the regulatory questions of this rulemaking. Hence,
although we are finalizing lower output limits based on the available
information, we are establishing the limits at 111 and 117 dB SPL
(peak, not RMS, values) rather than the even lower levels found or
suggested in some of the references submitted to us.
Other comments recommended FDA adopt international standards
developed jointly by the WHO and the International Telecommunication
Union (ITU). These comments identified ITU-T H.870 (2018), ``Guidelines
for safe listening devices/systems,'' and ITU-T H.871 (2019), ``Safe
listening guidelines for personal sound amplifiers.'' However, the
guidelines refer to a WHO-derived standard value for the cumulative
sound exposure for non-hearing-impaired adults. In other words, they
use a dosimetry-based method, which we do not believe is a suitable
basis to establish an appropriate limit, as explained above.
The guidelines do equate this to an output value of 80 dBA for 40
hours per week. However, the rationale underlying the guidelines relies
on WHO thresholds and citations to literature that, as explained, FDA
is not adopting and does not consider definitive (see the response to
Comment 24 about the WHO hearing loss thresholds). Further, as even
ITU-T H.871 (2019) explains, Ref. 10 can be read to suggest 90 dB SPL
RMS as the maximum sound output for persons with normal hearing (see
Appendix II of ITU-T H.871 (2019)). Such maximum sound output
recommendations for normal-hearing listeners cannot be used to derive
maximum output limits for a hearing aid to compensate for perceived
mild to moderate hearing impairment. Thus, FDA is declining to adopt
this cumulative exposure limit or the equivalent peak output value.
The lack of sufficient data to establish regulatory limits based on
dosimetry does not, however, mean that dosimetry is not a useful
feature. Manufacturers that wish to include dosimetry-based features in
OTC hearing aids may do so.
Ultimately, as stated previously the output limits that we are
finalizing reflect a balancing of safety and effectiveness. By lowering
the output limit 3 dB SPL from the proposed rule, these output limits
result in a meaningfully lower risk to the intended users, without
unduly sacrificing effectiveness.
3. Applying Analyses to Real-World Use of Hearing Aids
As we explain in the responses to Comments 11 and 24, the
perception of hearing impairment is conceptually integral to
establishing the OTC category of hearing aids, and the application of
audiometric thresholds to make regulatory decisions is inconsistent
with how the hearing loss categories themselves were formulated.
Moreover, audiometric threshold ranges or databases of audiograms do
not necessarily reflect the needs and wants of the intended users of
OTC hearing aids in a precise way. As such, while quantitative analyses
provide useful information, including data on exposure versus stability
of hearing impairment, the conclusions have inherent limitations that
militate against adopting them wholesale for the regulatory purposes of
this rulemaking.
FDA also considered how hearing health care providers fit hearing
aids in

[[Page 50724]]

a clinical environment. Ordinarily, a fitting algorithm determines the
necessary amplification, including the effective output limit of the
device for a given user. The provider would then make

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