OTC Hearing Aids Final Rule - New Requirements

Contains Nonbinding Recommendations

Regulatory Requirements for Hearing
Aid Devices and Personal Sound
Amplification Products
______________________________________________________________________________

Guidance for Industry and
Food and Drug Administration Staff
Document issued on August 17, 2022.
The draft of this document was issued on October 20, 2021.
This document supersedes “Guidance for Industry and FDA Staff: Regulatory
Requirements for Hearing Aid Devices and Personal Sound Amplification
Products” issued February 25, 2009.
For questions about this document, contact OHT1: Office of Ophthalmic, Anesthesia,
Respiratory, ENT and Dental Devices/DHT1B: Division of Dental and ENT Devices/THT1B3:
ENT Devices Team at 301-796-5620.

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health

Contains Nonbinding Recommendations

Preface
Public Comment
You may submit electronic comments and suggestions at any time for Agency consideration to
https://www.regulations.gov. Submit written comments to the Dockets Management Staff, Food
and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 20852.
Identify all comments with the docket number FDA-2020-D-1380. Comments may not be acted
upon by the Agency until the document is next revised or updated.

Additional Copies
Additional copies are available from the Internet. You may also send an email request to CDRHGuidance@fda.hhs.gov to receive a copy of the guidance. Please include the document number
1832 and complete title of the guidance in the request.

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Table of Contents
I.

Introduction ............................................................................................................................. 4

II.

Background ............................................................................................................................. 5

III.

Definitions and Scope .......................................................................................................... 5

IV.

Regulatory Requirements..................................................................................................... 7
Hearing Aids .................................................................................................................... 7
Personal Sound Amplification Products (PSAPs)............................................................ 8
Distinction between PSAPs and Hearing Aids ................................................................ 9

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Regulatory Requirements for Hearing
Aid Devices and Personal Sound
Amplification Products
______________________________________________________________________________

Guidance for Industry and
Food and Drug Administration Staff
This guidance represents the current thinking of the Food and Drug Administration (FDA or
Agency) on this topic. It does not establish any rights for any person and is not binding on FDA
or the public. You can use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff
or Office responsible for this guidance as listed on the title page.

I.

Introduction

This guidance document identifies applicable legal requirements under the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) for hearing aids and for personal sound amplification
products (PSAPs). Hearing aids and PSAPs both affect a user’s ability to hear sound, but the
products have different intended uses, and are therefore subject to different regulatory controls.
Unlike hearing aids which are intended to aid a person with or compensate for hearing
impairment, PSAPs (as defined in Section III) are not intended to diagnose, treat, cure, mitigate,
or prevent disease and are not intended to affect the structure or function of the body. Therefore,
they are not considered to be “devices” as defined in the FD&C Act.1
A lack of clarity between PSAPs and hearing aids has contributed to stakeholder and consumer
confusion. This guidance is intended to describe hearing aids, PSAPs, their respective intended
uses, and the regulatory requirements that apply to both types of products.
The contents of this document do not have the force and effect of law and are not meant to
bind the public in any way, unless specifically incorporated into a contract. This document is
intended only to provide clarity to the public regarding existing requirements under the law.
FDA guidance documents, including this guidance, should be viewed only as
recommendations, unless specific regulatory or statutory requirements are cited. The use of the

1

See section 201(h) of the FD&C Act (21 U.S.C. 321(h)).

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word should in Agency guidance means that something is suggested or recommended, but not
required.

II. Background
The FDA Reauthorization Act of 2017 (FDARA) (Pub. L. 115-52) directs FDA to establish a
category of over-the-counter (OTC) hearing aids through rulemaking, and mandates that FDA
establish various requirements for this category of devices. FDA has finalized a rule to establish
the OTC category of hearing aids and implement the requirements of FDARA (“Rule”).2 In this
Rule, FDA made multiple related changes to the overall regulatory framework for hearing aids to
harmonize existing regulations with the OTC category while continuing to provide reasonable
assurance of safety and effectiveness. Specifically, this Rule defines OTC hearing aids and
establishes applicable requirements; amends existing rules for consistency with the new OTC
category, and these amended rules apply to most other hearing aids which are now regulated as
prescription devices (21 CFR 801.422); repeals the conditions for sale that were applicable to
hearing aids under 21 CFR 801.421; and updates regulations relating to decisions on applications
for exemption from Federal preemption that are obsolete as a result of changes to the hearing aid
requirements. This guidance references the citations set forth in the Rule (e.g., 21 CFR 800.30).
FDARA also directed FDA to update and finalize the draft guidance entitled “Regulatory
Requirements for Hearing Aid Devices and Personal Sound Amplification Products,” issued on
November 7, 2013.3 In order to fulfill this FDARA requirement, FDA updated the November 7,
2013 draft guidance by issuing a draft guidance on October 20, 2021. This guidance finalizes the
2021 draft guidance and supersedes the February 25, 2009 guidance. The Rule creates a
heightened need to appropriately inform consumers by clearly distinguishing PSAPs from OTC
hearing aids from a regulatory standpoint. This guidance is intended to accomplish that goal. We
intend to continue to take a risk-based approach to enforcing our regulations to protect the public
health.
FDA provides additional information regarding hearing aids on the following website:
https://www.fda.gov/medical-devices/consumer-products/hearing-aids.

III. Definitions and Scope
A hearing aid is “any wearable device designed for, offered for the purpose of, or represented as
aiding persons with or compensating for, impaired hearing” (21 CFR 800.30(b) and 21 CFR
801.422(b)). This definition encompasses both air-conduction and bone-conduction devices in a
variety of styles (e.g., behind-the-ear, in-the-canal, body worn). Hearing aids are devices as

2

“Establishing Over-the-Counter Hearing Aids” (87 FR 50698) available at:
https://www.federalregister.gov/d/2022-17230.
3
See FDARA section 709(c) (Pub. L. 115-52, 131 Stat. 1067).

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defined by section 201(h) of the FD&C Act.4 Hearing aids do not include cochlear implants or
implantable middle ear hearing devices, which are class III devices that require an approved
premarket approval (PMA) application before marketing (section 513(a) of the FD&C Act). In
contrast, an electronic product5 that is intended for non-hearing impaired consumers to amplify
sounds in certain environments, such as for hunting or other recreational activities, and is not
intended to aid persons with or compensate for impaired hearing, is considered a PSAP. Such
PSAPs are not devices as defined in section 201(h) of the FD&C Act and therefore, are not
regulated as such.
Currently, hearing aid devices may be classified6 as:
· class I devices, exempt7 from premarket notification (510(k)) (21 CFR 874.3300);
· class II devices, which require premarket notification (510(k)) and compliance with
special controls (if applicable to the specific regulation) before marketing (21 CFR
874.3302, 21 CFR 874.3315, 21 CFR 874.3325, and 21 CFR 874.3950); or
· class II devices that are exempt8 from premarket notification (510(k)), subject to
required special controls (21 CFR 874.3305). 9
Product codes for the various types of devices under these classification regulations are listed in
Table 1:

4

A device is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or
related article, including any component, part, or accessory, intended for use in the diagnosis of disease or other
conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to
affect the structure or any function of the body of man or other animals, and which does not achieve its primary
intended purposes through chemical action within or on the body of man or other animals and which is not
dependent upon being metabolized for the achievement of its primary intended purposes. The term "device" does not
include software functions excluded pursuant to section 520(o). See section 201(h) of the FD&C Act (21 U.S.C.
321(h)).
5
The term “electronic product” means (A) any manufactured or assembled product which, when in operation, (i)
contains or acts as part of an electronic circuit and (ii) emits (or in the absence of effective shielding or other controls
would emit) electronic product radiation, or (B) any manufactured or assembled article which is intended for use as a
component, part, or accessory of a product described in clause (A) and which when in operation emits (or in the
absence of effective shielding or other controls would emit) such radiation. See section 531(2) of the FD&C Act (21
U.S.C. 360hh(2)).
6
Tactile hearing aids, under product code LRA, are currently unclassified devices, subject to premarket notification
(510(k)). They are a preamendments device type and do not have a classification regulation.
7
Refer to 21 CFR 874.9 for the limitations of exemptions from 510(k).
8
Ibid.
9
In accordance with 21 CFR 874.9, an air-conduction hearing aid device under 21 CFR 874.3300 and a wireless airconduction hearing aid under 21 CFR 874.3305 are exempt from premarket notification unless the device: 1) is
intended for a use different from the intended use of a legally marketed device of that generic type, or 2) if the
device operates using a different fundamental scientific technology than a legally marketed device of that generic
type.

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Table 1 – Relevant Product Codes
Regulation Number
21 CFR 874.3300
21 CFR 874.3300
21 CFR 874.3300
21 CFR 874.3302
21 CFR 874.3302
21 CFR 874.3305
21 CFR 874.3315
21 CFR 874.3325
21 CFR 874.3950

Product Code and Name
LRB (Face Plate Hearing Aid)
ESD (Hearing Aid, Air Conduction)
LDG (Kit, Earmold, Impression)
LXB (Hearing Aid, Bone Conduction)
MAH (Hearing Aid, Bone Conduction, Implanted)
OSM (Hearing Aid, Air Conduction with Wireless
Technology)
PLK (Tympanic Membrane Direct Contact Hearing Aid)
QDD (Self-Fitting Air-Conduction Hearing Aid)
NIX (Hearing Aid, Air Conduction, Transcutaneous System)

Although the product codes listed above are current as of the date of issuance of this guidance,
new product codes may be created over time for hearing aids regulated under the classification
regulations identified above and would fall within the scope of this guidance. We recommend
that you reference the product code database
(http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm) if you are unsure
whether this guidance applies to your device and the product code for your device is not already
captured in this guidance.
Although the Rule amends the classification regulations for hearing aids, this does not impact the
scope of this guidance. This final guidance aligns and is consistent with the Rule.
This guidance does not apply to the group hearing aid or group auditory trainer (21 CFR
874.3320), master hearing aid (21 CFR 874.3330), and tinnitus masker (21 CFR 874.3400).

IV. Regulatory Requirements
As discussed in Section III, hearing aids are devices under section 201(h) of the FD&C Act and
PSAPs (as defined in Section III) are not devices as defined by section 201(h) and therefore, are
not regulated as such. This section provides further clarity regarding the intended uses of hearing
aids and PSAPs and the regulatory requirements for both types of products.

Hearing Aids
As devices, hearing aids are subject to applicable device requirements under the FD&C Act and
FDA regulations (e.g., adverse event reporting). FDA regulations also include specific
requirements for hearing aids, such as labeling, that are further discussed below. Hearing aids are
also electronic products, and therefore, are subject to applicable electronic product requirements
under the FD&C Act and FDA regulations (these requirements are discussed in the PSAP section
below).
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FDA’s regulation of OTC and prescription hearing aids is intended to provide consumers access
to safe and effective hearing aids and ensure that consumers understand how to use available
technology and understand when to seek an evaluation by a qualified professional. Specific
information in hearing aid labeling is essential in order for consumers or hearing aid dispensers
to identify conditions that either may pose a threat to health if left undiagnosed, or avoid
unnecessary and inappropriate hearing aid use (e.g., cerumen (earwax) impaction). Specific
information in hearing aid labeling will also help consumers and hearing aid dispensers choose
appropriate hearing aids that are safe and effective for the consumer’s hearing condition.
Equipped with this information, consumers can better decide how to address their needs among
all options available to them.
The Rule requires OTC hearing aids, as defined therein, to comply with the requirements for
OTC hearing aids (21 CFR 800.30), which include, among others, labeling, performance, and
design requirements, in addition to other applicable requirements, including but not limited to
special controls found in the applicable classification regulation. Hearing aids that meet the
definition of, and satisfy the requirements for, OTC hearing aids, are considered “available” over
the counter as specified in section 520(q)(1)(A)(v) of the FD&C Act. Any hearing aid that does
not meet the definition of an OTC hearing aid or satisfy the requirements of 21 CFR 800.30 will
be a prescription device.10
The Rule also repeals the conditions for sale in 21 CFR 801.42111 and amends the labeling
requirements in 21 CFR 801.420 (by moving them to 21 CFR 801.422, limiting their scope to
prescription hearing aids, and revising them as appropriate to provide consistency with the new
labeling requirements for OTC hearing aids in 21 CFR 800.30). Thus, prescription hearing aids
must comply with the hearing aid specific requirements in 21 CFR 801.422 in addition to other
applicable requirements, including but not limited to special controls found in the applicable
classification regulation.

Personal Sound Amplification Products (PSAPs)
This subsection describes PSAPs that fall within the definition provided in Section III of this
document. PSAPs are not intended to compensate for hearing impairment. They are intended to
accentuate sounds in specific listening environments for non-hearing impaired listeners. Because
PSAPs are not intended to diagnose, treat, cure, mitigate, or prevent disease and are not intended
to affect the structure or function of the body, they are not devices as defined in the FD&C Act.12
As such, there is no regulatory classification or product code for these products. Furthermore,
there are no requirements for registration of manufacturers or listing of these products with FDA.
However, PSAPs are subject to applicable provisions of the Radiation Control for Health and
10

See 21 CFR 801.422.
Previously, all hearing aids were subject to required conditions for sale provided in 21 CFR 801.421. FDA’s
guidance, “Conditions for Sale for Air-Conduction Hearing Aids,” issued on December 12, 2016, described the
Agency’s previous enforcement policy with respect to the conditions for sale. FDA withdrew this guidance on
October 17, 2022. See https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiationemitting-products/withdrawn-guidance.
12
See section 201(h) of the FD&C Act (21 U.S.C. 321(h)).
11

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Safety Act of 1968,13 under which FDA regulates electronic products that emit sonic vibrations,
such as sound amplification equipment.14 Manufacturers of PSAPs must report accidental
radiation occurrences under 21 CFR Part 1002, and report defects and take other measures
described in 21 CFR Part 1003. Manufacturers of PSAPs must also comply with the requirements
to repurchase, repair, or replace electronic products under 21 CFR Part 1004.
Examples of situations in which PSAPs typically are used include hunting (listening for prey),
bird watching, listening to lectures with a distant speaker, and listening to soft sounds that would
be difficult for normal hearing individuals to hear (e.g., distant conversations).

Distinction between PSAPs and Hearing Aids
FDA is aware of confusion in the marketplace over what FDA considers a hearing aid and what
it considers a PSAP. While the technology of hearing aids and PSAPs may be similar, FDA
considers the intended use of each product to determine whether it is a device or solely an
electronic product. A product’s intended use refers to the “objective intent” of those legally
responsible for the labeling of the product, which may be shown by their oral or written
expressions, the design or composition of the product, or by the circumstances surrounding the
distribution of the product.15 This objective intent may be shown, for example, by the claims
made in product labeling or advertising, and from other relevant sources.16,17 Accordingly, FDA
may consider, among other things, any written or oral claims or statements in any label, labeling,
advertising, and/or promotion of a product by or on behalf of a firm18 in determining whether a
product is a device.
Explicitly or implicitly claiming or stating that a product addresses, mitigates, or improves
hearing loss/impaired hearing would be considered an intent to diagnose, treat, cure, mitigate, or
prevent disease or to affect the structure or function of the body. The following are examples of
explicit or implicit claims or statements that FDA believes would generally cause the product to
meet the device definition, in which case the product would be subject to the regulatory
requirements applicable to devices, including the specific requirements applicable to hearing
aids, as discussed above in this guidance:
·
·

suggestions that the product is for users with certain types or severity of hearing
loss/impaired hearing;
suggestions that the product is indicated for use in situations that are typically
associated with and indicative of hearing loss/impaired hearing;

13

See sections 531 to 542 of the FD&C Act (21 U.S.C. 360hh-ss).
See 21 CFR 1000.15(d).
15
See 21 CFR 801.4.
16
See id.
17
“Labeling” is defined in section 201(m) of the FD&C Act (21 U.S.C. 321(m)) as “all labels and other written,
printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such
article.” Labeling may include promotional materials.
18
For the purposes of this guidance document, the term “firm” is used to refer to “persons legally responsible for the
labeling of an article (or their representatives)” under 21 CFR 801.4.
14

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·

·

suggestions that the product is an alternative to a hearing aid (PSAPs are not
considered “over-the-counter” alternatives or substitutes for a hearing aid), for
example, marketing it as a less expensive alternative to hearing aids or marketing it to
consumers who may have hearing loss/impaired hearing and are not yet ready to buy
hearing aids;
information conveyed to the user to optimize the product to their hearing
loss/impaired hearing profile (e.g., providing hearing thresholds or a measure of
hearing loss/impaired hearing, or using a hearing aid fitting formula or other
algorithms to program the product output to match the user’s hearing loss/impaired
hearing profile).

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