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# Guide on OTC Hearing Aids
- URL: https://www.fdaweb.com/guide-on-otc-hearing-aids/
- Published: 2022-08-17T12:00:00.000Z
- Updated: 2026-09-14T17:56:09.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5152524

*Federal Register* notice: FDA is making available a [final guidance](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/regulatory-requirements-hearing-aid-devices-and-personal-sound-amplification-products?ref=fdaweb.com) entitled “Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products (PSAPs).” FDA says 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…are not intended to diagnose, treat, cure, mitigate, or prevent disease and are not intended to affect the structure or function of the body,” it says. Therefore, they are not considered to be ‘devices’ as defined in the FD&C Act. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2022-08-17/pdf/2022-17231.pdf?ref=fdaweb.com).