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# OTC Hearing Aids Proposed Rule
- URL: https://www.fdaweb.com/otc-hearing-aids-proposed-rule/
- Published: 2021-10-20T12:00:00.000Z
- Updated: 2026-09-14T17:19:35.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5150403

*Federal Register* proposed rule: FDA is proposing to establish a regulatory category for over-the-counter (OTC) hearing aids and to make related amendments to update the regulatory framework for such devices. Specifically, it seeks to define OTC hearing aids and establish applicable requirements; amend existing rules for consistency with a new OTC category; repeal the conditions for sale applicable to hearing aids; amend the existing labeling requirements for hearing aids; and update regulations relating to decisions on applications for exemption from federal preemption that would become obsolete as a result of changes to the hearing aid requirements. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2021-10-20/pdf/2021-22473.pdf?ref=fdaweb.com).