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Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products Draft Guidance for Industry and Food and Drug Administration Staff October 2021


Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

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Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2020-D-1380

Docket Number:
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Guidance Issuing Office
Center for Devices and Radiological Health

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.

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 which apply to both types of products.

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