Rule2026-11589
Medical Devices; Ear, Nose, and Throat Devices; Classification of the Combined Acoustic and Electrical External Stimulation Device for the Relief of Tinnitus
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
June 10, 2026
Effective
June 10, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is classifying the combined acoustic and electrical external stimulation device for the relief of tinnitus into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the combined acoustic and electrical external stimulation device for the relief of tinnitus. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Full Text
<html>
<head>
<title>Federal Register, Volume 91 Issue 111 (Wednesday, June 10, 2026)</title>
</head>
<body><pre>
[Federal Register Volume 91, Number 111 (Wednesday, June 10, 2026)]
[Rules and Regulations]
[Pages 35138-35140]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-11589]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 874
[Docket No. FDA-2026-N-6010]
Medical Devices; Ear, Nose, and Throat Devices; Classification of
the Combined Acoustic and Electrical External Stimulation Device for
the Relief of Tinnitus
AGENCY: Food and Drug Administration, HHS.
ACTION: Final amendment; final order.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is classifying the
combined acoustic and electrical external stimulation device for the
relief of tinnitus into class II (special controls). The special
controls that apply to the device type are identified in this order and
will be part of the codified language for classification of the
combined acoustic and electrical external stimulation device for the
relief of tinnitus. We are taking this action because we have
determined that classifying the device into class II will provide a
reasonable assurance of safety and effectiveness of the device. We
believe this action will also enhance patients' access to beneficial
innovative devices, in part by reducing regulatory burdens.
DATES: This order is effective June 10, 2026. The classification was
applicable on March 6, 2023.
FOR FURTHER INFORMATION CONTACT: Shu-Chen Peng, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1224, Silver Spring, MD 20993-0002, 301-796-6481,
<a href="/cdn-cgi/l/email-protection#7e2d160b533d161b10502e1b10193e181a1f5016160d50191108"><span class="__cf_email__" data-cfemail="82d1eaf7afc1eae7ecacd2e7ece5c2e4e6e3aceaeaf1ace5edf4">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA (the Agency or we) has classified the combined
acoustic and electrical external stimulation device for the relief of
tinnitus into class II (special controls), which we have determined
will provide a reasonable assurance of safety and effectiveness of the
device. In addition, we believe this action will enhance patients'
access to beneficial innovation, in part by reducing regulatory burdens
by placing the device into a lower device class than the automatic
class III assignment.
The automatic assignment of class III occurs by operation of law
and without any action by FDA, regardless of the level of risk posed by
the new device. Any device that was not in commercial distribution
before May 28, 1976, is automatically classified into, and remains
within, class III and requires premarket approval unless and until FDA
takes an action to classify or reclassify the device (21 U.S.C.
360c(f)(1)). We refer to these devices as ``postamendments devices''
because they were not in commercial distribution prior to the date of
enactment of the Medical Device Amendments of 1976, which amended the
Federal Food, Drug, and Cosmetic Act (FD&C Act).
FDA may take a variety of actions in appropriate circumstances to
classify or reclassify a device into class I or II. We may issue an
order finding a new device to be substantially equivalent under section
513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that
does not require premarket approval. We determine whether a new device
is substantially equivalent to a predicate device by means of the
procedures for premarket notification under section 510(k) of the FD&C
Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).
FDA may also classify a device through ``De Novo'' classification,
a common name for the process authorized under section 513(f)(2) of the
FD&C Act (see also part 860, subpart D (21 CFR part 860, subpart D)).
Section 207 of the Food and Drug Administration Modernization Act of
1997 (Pub. L. 105-115) established the first procedure for De Novo
classification. Section 607 of the Food and Drug Administration Safety
and Innovation Act (Pub. L. 112-144) modified the De Novo
classification process by adding a second procedure. A device sponsor
may utilize either procedure for De Novo classification.
Under the first procedure, the person submits a premarket
notification (510(k)) for a device that has not previously been
classified. After receiving an order from FDA classifying the device
into class III under section 513(f)(1) of the FD&C Act, the person then
requests a classification under section 513(f)(2).
Under the second procedure, rather than first submitting a 510(k)
and then a request for classification, if the person determines that
there is no legally marketed device upon which to base a determination
of substantial equivalence, that person requests a
[[Page 35139]]
classification under section 513(f)(2) of the FD&C Act.
Under either procedure for De Novo classification, FDA is required
to classify the device by written order within 120 days. The
classification will be according to the criteria under section
513(a)(1) of the FD&C Act. Although the device was automatically placed
within class III, the De Novo classification is considered to be the
initial classification of the device.
We believe this De Novo classification will enhance patients'
access to beneficial innovation, in part by reducing regulatory
burdens. When FDA classifies a device into class I or II via the De
Novo process, the device can serve as a predicate for future devices of
that type, including for 510(k)s (see section 513(f)(2)(B)(i) of the
FD&C Act). As a result, other device sponsors do not have to submit a
De Novo request or premarket approval application to market a
substantially equivalent device (see section 513(i) of the FD&C Act,
defining ``substantial equivalence''). Instead, sponsors can use the
less burdensome 510(k) process, when necessary, to market their device.
II. De Novo Classification
On August 18, 2021, FDA received Neuromod Devices Limited's request
for De Novo classification of the Lenire device. FDA reviewed the
request in order to classify the device under the criteria for
classification set forth in section 513(a)(1) of the FD&C Act.
We classify devices into class II if general controls by themselves
are insufficient to provide reasonable assurance of safety and
effectiveness of the device, but there is sufficient information to
establish special controls that, in combination with the general
controls, provide reasonable assurance of the safety and effectiveness
of the device for its intended use (see section 513(a)(1)(B) of the
FD&C Act). After review of the information submitted in the request, we
determined that the device can be classified into class II with the
establishment of special controls. FDA has determined that these
special controls, in addition to the general controls, will provide
reasonable assurance of the safety and effectiveness of the device.
Therefore, on March 6, 2023, FDA issued an order to the requester
classifying the device into class II. In this final order, FDA is
codifying the classification of the device by adding 21 CFR
874.3410.\1\ We have named the generic type of device ``combined
acoustic and electrical external stimulation device for the relief of
tinnitus,'' and it is identified as a device that provides acoustic
stimulation in the ear and external, electrical stimulation of sensory
nerves to relieve tinnitus.
---------------------------------------------------------------------------
\1\ FDA notes that the ``ACTION'' caption for this final order
is styled as ``Final amendment; final order,'' rather than ``Final
order.'' Beginning in December 2019, this editorial change was made
to indicate that the document ``amends'' the Code of Federal
Regulations. The change was made in accordance with the Office of
Federal Register's (OFR) interpretations of the Federal Register Act
(44 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9 and
parts 21 and 22), and the Document Drafting Handbook.
---------------------------------------------------------------------------
FDA has identified the risks to health associated with this type of
device and the measures required to mitigate these risks in table 1.
Table 1--Risks to Health and Mitigation Measures for Combined Acoustic
and Electrical External Stimulation Device For the Relief of Tinnitus
------------------------------------------------------------------------
Identified risks to health Mitigation measures
------------------------------------------------------------------------
Adverse tissue reaction................ Biocompatibility evaluation;
and Labeling.
Thermal and electrical safety: Injury Non-clinical performance
from electrical current on skin or testing; Clinical performance
mucosa causing one or more of the testing; Human factors
following: testing; Software
<bullet> Burn. verification, validation, and
<bullet> Irritation. hazard analysis; Electrical
<bullet> Electrical shock. safety testing;
<bullet> Pain. Electromagnetic compatibility
<bullet> Glandular hypersecretion. testing; Battery safety
<bullet> Headache. testing; and Labeling.
Increase in tinnitus or associated Clinical performance testing;
behavior issues during treatment. and Labeling.
Hearing loss from overstimulation...... Non-clinical performance
testing; and Labeling.
------------------------------------------------------------------------
FDA has determined that special controls, in combination with the
general controls, address these risks to health and provide reasonable
assurance of safety and effectiveness of the device. For a device to
fall within this classification, and thus avoid automatic
classification in class III, it would have to comply with the special
controls named in this final order. The necessary special controls
appear in the regulation codified by this final order.
Under the FD&C Act, submission of a premarket notification under
section 510(k) is required to reasonably assure the safety and
effectiveness of class II devices unless FDA determines that the device
type should be exempt under section 510(m) of the FD&C Act. At this
time FDA has not made this determination for combined acoustic and
electrical external stimulation devices for the relief of tinnitus.
This device is therefore subject to premarket notification requirements
under section 510(k) of the FD&C Act.
III. Analysis of Environmental Impact
The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not normally have a significant effect on the human
environment. Therefore, neither an environmental assessment nor an
environmental impact statement is required.
IV. Paperwork Reduction Act of 1995
This final order establishes special controls that refer to
previously approved collections of information found in other FDA
regulations and guidance. These collections of information are subject
to review by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections
of information in part 860, subpart D, regarding De Novo classification
have been approved under OMB control number 0910-0844; the collections
of information in 21 CFR part 814, subparts A through E, regarding
premarket approval have been approved under OMB control number 0910-
0231; the collections of information in part 807, subpart E, regarding
premarket notification submissions have been approved under OMB control
number 0910-0120; the collections of information in 21 CFR
[[Page 35140]]
part 820 regarding quality management system regulation have been
approved under OMB control number 0910-0073; and the collections of
information in 21 CFR part 801 regarding labeling have been approved
under OMB control number 0910-0485.
List of Subjects in 21 CFR Part 874
Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
874 is amended as follows:
PART 874--EAR, NOSE, AND THROAT DEVICES
0
1. The authority citation for part 874 continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
2. Add Sec. 874.3410 to subpart D to read as follows:
Sec. 874.3410 Combined acoustic and electrical external stimulation
device for the relief of tinnitus.
(a) Identification. A combined acoustic and electrical external
stimulation device for the relief of tinnitus is a device that provides
acoustic stimulation in the ear and external, electrical stimulation of
sensory nerves to relieve tinnitus.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) Clinical performance testing must demonstrate performance as
intended under anticipated conditions for use including the following:
(i) Evaluation of tinnitus symptoms using a validated method; and
(ii) Evaluation of all adverse events.
(2) Non-clinical performance testing must demonstrate that the
device performs as intended under anticipated conditions of use,
including the following:
(i) Verification of specified electrical stimulation parameters;
and
(ii) Verification of specified acoustic stimulation parameters,
including maximum output limits, distortion levels, and frequency
response.
(3) Performance data must demonstrate the electromagnetic
compatibility, battery safety, and electrical safety of the device.
(4) Software verification, validation, and hazard analysis must be
performed.
(5) The patient-contacting components of the device must be
demonstrated to be biocompatible.
(6) Human factors testing must demonstrate that users can
successfully use the device in the intended use environment based
solely on its labeling and instructions for use.
(7) Labeling must include the following:
(i) A statement that the device is intended to be prescribed by a
healthcare professional with expertise in the evaluation and management
of tinnitus;
(ii) Information regarding emotional, psychological, and physical
considerations for patient selection; and
(iii) Device specifications, including the materials of patient-
contacting components of the device, electrical output waveform,
stimulation peak voltage and current, pulse duration, frequency,
maximum current density, maximum phase charge, and power source.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-11589 Filed 6-9-26; 8:45 am]
BILLING CODE 4164-01-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on June 10, 2026.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.