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GUIDANCE DOCUMENT

Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products Guidance for Industry and Food and Drug Administration Staff August 2022

Read the Federal Register Notice
Final
Docket Number:
FDA-2020-D-1380
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

Download the 2009 Final Guidance Document Download the 2022 Final Guidance Document

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). 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.

Submit Comments

Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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.

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