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Today’s Topic:

Over-the-Counter (OTC) Hearing Aids, Proposed Rule

Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products 

(PSAPs), Draft Guidance

December 07, 2021
Over-the-Counter (OTC) Hearing Aids Proposed Rule

and

Personal Sound Amplification Products (PSAPs) Draft Guidance

Eric A. Mann, MD, PhD

Chief Medical Officer

OHT1/OPEQ

Ian Ostermiller, JD

Policy Advisor

Office of Policy

Srinivas “Nandu” Nandkumar, PhD

Director, Division of Dental and ENT Devices

OHT1/OPEQ

Vasant Dasika, PhD

Biomedical Engineer

OHT1/OPEQ

Center for Devices and Radiological Health

U.S. Food and Drug Administration
Over-the-Counter (OTC) Hearing Aids Proposed Rule

and

Personal Sound Amplification Products (PSAPs) Draft Guidance

Eric A. Mann, MD, PhD

Chief Medical Officer

OHT1/OPEQ

Ian Ostermiller, JD

Policy Advisor

Office of Policy

Srinivas “Nandu” Nandkumar, PhD

Director, Division of Dental and ENT Devices

OHT1/OPEQ

Vasant Dasika, PhD

Biomedical Engineer

OHT1/OPEQ

Center for Devices and Radiological Health

U.S. Food and Drug Administration
Proposed Rule and Draft Guidance

• Proposed Rule: Establishing Over-the-Counter Hearing Aids

– www.federalregister.gov/documents/2021/10/20/2021-22473/medical-devices-ear-noseand-throat-devices-establishing-over-the-counter-hearing-aids

• Draft Guidance: Regulatory Requirements for Hearing Aid Devices and Personal 

Sound Amplification Products

– www.fda.gov/regulatory-information/search-fda-guidance-documents/regulatoryrequirements-hearing-aid-devices-and-personal-sound-amplification-products

• Some Acronyms We’ll Use Frequently:

– OTC = Over-the-Counter

– PSAP = Personal Sound Amplification Product

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Learning Objectives

• Identify current landscape of hearing aid regulations

• Summarize proposed rule for over-the-counter 

hearing aids

• Summarize distinctions between hearing aids and 

PSAPs outlined in the draft guidance

• Identify where and how to provide written comments 

on PR and draft guidance

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Current Landscape of

Hearing Aid Regulations

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Hearing Aid Use

• About 28.8 million US adults could benefit from hearing aid (HA) use1

• Low rate of usage among adults1

– > 70yr old, < 30% have ever used HAs

– < 70 yr old, ~16% have ever used HAs

• Barriers to HA usage

– Stigma

– Cost/Value

– Federal and state regulations

1 NIH Quick Statistics About Hearing: www.nidcd.nih.gov/health/statistics/quick-statistics-hearing

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Devices to Treat Hearing Loss

Hearing Aids: 

• Air-Conduction

• Bone-Conduction

Implantable hearing aids

Cochlear Implants

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Current Regulations

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• Air-conduction hearing aids

– Air-conduction hearing aid [21 CFR 874.3300(b)(1)] 

– Wireless air-conduction hearing aid [21 CFR 874.3305]

– Self-fitting air-conduction hearing aid [21 CFR 874.3325]

• Most air-conduction hearing aids

– are currently not prescription devices

– but are subject to certain federal restrictions
Current Regulations (cont.)

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• Labeling requirements (21 CFR 801.420)

• Conditions for sale (21 CFR 801.421)

− Medical evaluation within 6 months of dispensing

− Waiver allowed for users 18 year and older

− Record keeping requirements

− Regulatory flexibility for certain conditions for sale 

provided through FDA Guidance “Condition for Sale of AirConducting Hearing Aids”

www.fda.gov/regulatory-information/search-fda-guidance-documents/immediately-effect-guidance-document-conditions-saleair-conduction-hearing-aids
Current Regulations (cont.)

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• Additional regulations in some U.S. States

– Testing requirements

– Medical evaluation

– Restrictions on internet/mail order sales

– Licensing requirements for dispensers
Proposed Rule for

Over-The-Counter Hearing Aids

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Ian Ostermiller, JD

Policy Advisor

Office of Policy
Goals of FDA’s Proposals

• Maintain reasonable assurance of safety and effectiveness

• Implement § 709 of FDARA, new § 520(q) of the FD&C Act

• Establish regulatory requirements for OTC hearing aids

• Address preemption of State requirements under FDARA 

• Realign current regulations for consistency

FDARA = FDA Reauthorization Act of 2017

FD&C Act = Federal Food, Drug, and Cosmetic Act

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FDARA § 709 Requirements

• Must establish OTC category that includes:

– Requirements to provide reasonable assurance of safety and effectiveness of 

OTC hearing aids

– Output (volume) limits appropriate for OTC hearing aids

– Appropriate labeling, including “conspicuous statement” that the device is 

only intended for people age 18 and older

– Conditions for sale of OTC hearing aids

• Must finalize updated PSAP guidance with final 

rule

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Strategy for Proposal

• Update “rules of the road” for air-conduction hearing aids

• We are not creating a device type unique to OTC devices

– This proposal is not for a device clearance or approval

– Devices already on the market could use the OTC lane

• To market hearing aids as OTC

– Existing devices would likely need at least labeling updates

– A 510(k) could be required, depending on specifics of changes

– Other requirements would apply too, e.g., registration and listing

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21 CFR 801.422 – ℞ Hearing Aids

• Scope

• Definitions

• Labeling

(Prescription Use)

Proposed Regulations

21 CFR 800.30 – OTC Hearing 

Aids

• Scope

• Definitions

• Labeling

• Output limits

• Electroacoustic performance

• Design requirements

• Condition for sale

• Effect on state laws

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OTC Hearing Aids:

Proposed Technical and

Performance Specifications

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Vasant Dasika, PhD

Biomedical Engineer

OHT1/OPEQ
Maximum Output Limit

21 CFR 800.30(d)

• OSPL90 shall not exceed

− 115 dB SPL, or

− 120 dB SPL, with both input-controlled compression and volume control

• Rationale: Maximum output should be neither too high, nor too low, 

and achieve both: 

− Safety: by reducing risk to residual hearing via an appropriately set upper limit

− Effectiveness: by providing sufficient dynamic range and allowing adequate 

amplification for mild to moderate hearing loss

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Electroacoustic Performance

21 CFR 800.30(e)

• Total harmonic distortion plus noise: ≤ 5%

• Self-generated noise: ≤ 32 dB SPL

• Latency: ≤ 15 ms

• Frequency response bandwidth: ≤ 250Hz to ≥ 5kHz

• Frequency response smoothness

– no undue peaks/troughs in frequency response

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Design Requirements

21 CFR 800.30(f)

• Insertion depth

– Hearing aid design shall limit insertion of eartip to no deeper than bony-cartilaginous junction of 

external auditory canal

• Use of atraumatic materials

– Eartip material of an OTC hearing aid shall be atraumatic

• Proper physical fit

– Design shall enable consumers to readily achieve a safe, customized, acoustically favorable, and 

comfortable physical fit

• Tools, tests, or software

– Through tools, tests, or software, shall permit lay user to control device and customize it to user’s 

hearing needs

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Hearing Aids and PSAPs:

Distinctions Outlined in Draft Guidance

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Srinivas “Nandu” Nandkumar, PhD

Director, Division of Dental and ENT Devices

OHT1/OPEQ
Regulatory Requirements

• Hearing Aid

– Intended to aid persons with or compensate for hearing impairment

– Meets definition of a device, per § 201(h) of FD&C Act

– Subject to applicable device requirements under FD&C Act and FDA 

regulations

• Personal Sound Amplification Product (PSAP)

– Intended for non-hearing-impaired consumers to amplify sounds in certain 

environments and 

– Not intended to aid persons with or compensate for hearing impairment

– Does not meet definition of a device, per § 201(h) of FD&C Act

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Radiation Health Requirements

• Both are electronic products that emit sound

• FDA regulates electronic products that emit sound through the 

authorities provided by the Radiation Control for Health and Safety 

Act of 1968 (now incorporated into the FD&C Act)

• PSAP Manufacturers responsibilities include:

– Report defects 

– Comply with the requirements to repurchase, repair, or replace electronic 

products

– Report accidental radiation occurrences

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Examples Where PSAPs Are Used

• Hunting (listening for prey) 

• Bird watching

• Listening to lectures with a distant speaker 

• Listening to soft sounds difficult for normal 

hearing individuals to hear

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Distinction Between

Hearing Aids and PSAPs • FDA considers intended use of each product to determine if it is a device or solely an 

electronic product

• Product’s intended use refers to “objective intent” (21 CFR 801.4) of those legally 

responsible for labeling

• May, for example, be shown by the design or composition of an article, or by written 

or oral claims or statements in any:

– label and labeling 

– advertising

– promotion of a product by or on behalf of a firm

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Examples of Explicit/Implicit Claims

• For users with certain types or severity of hearing loss/impaired hearing

• In situations that are typically associated with and indicative of hearing 

loss/impaired hearing

• Alternative to a hearing aid

• Information conveyed to user to optimize product to their hearing 

loss/impaired hearing profile

 These would generally cause a PSAP to be a medical device (hearing aid)

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Providing Comments on

Proposed Rule and Draft Guidance

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A Note about Draft Guidances

• You may comment on any guidance at any time

– see 21 CFR 10.115(g)(5)

• Please submit comments on draft guidance before 

closure date

– to ensure that FDA considers your comment on a draft 

guidance before we work on final guidance

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Submit Comments to Dockets by:

January 18, 2022 • Proposed Rule: Establishing Over-the-Counter Hearing Aids

– www.federalregister.gov/documents/2021/10/20/2021-22473/medical-devices-ear-nose-and-throatdevices-establishing-over-the-counter-hearing-aids

– Docket: FDA-2021-N-0555 (www.regulations.gov/docket/FDA-2021-N-0555)

• Draft Guidance: Regulatory Requirements for Hearing Aid Devices and Personal 

Sound Amplification Products

– www.fda.gov/regulatory-information/search-fda-guidance-documents/regulatory-requirements-hearingaid-devices-and-personal-sound-amplification-products

– Docket: FDA-2020-D-1380 (www.regulations.gov/docket/FDA-2020-D-1380)

→ Submit separately to each docket

→ Online or by mail to designated docket

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Summary

• Hearing aids have an extensive history of use and FDA regulation

• Proposed rule serves to create requirements to provide reasonable 

assurance of safety and effectiveness for over-the-counter hearing 

aids

• Proposes design, technical and performance requirements

• As draft guidance discusses, intended use helps to guide whether a 

product is a hearing aid (medical device) or a PSAP (not a medical 

device)

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