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# No Final Regulation Yet on OTC Hearing Aids
- URL: https://www.fdaweb.com/no-final-regulation-yet-on-otc-hearing-aids/
- Published: 2018-07-24T12:00:00.000Z
- Updated: 2026-09-15T00:21:29.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5141941

FDA is reminding hearing aid manufacturers that until the effective date of a published final regulation, there are no products that can legally claim to be over-the-counter hearing aids within the definition included in section 709 of the FDA Reauthorization Act of 2017\. An agency [letter](https://www.fda.gov/downloads/MedicalDevices/ResourcesforYou/Industry/UCM614345.pdf?ref=fdaweb.com) to manufacturers says that “currently hearing aids continue to be restricted devices, for which sales must follow applicable federal and state requirements.”

Section 709 requires FDA to publish proposed regulations by 8/18/20, consider public comments, and then publish a final regulation within 180 days of the close of the comment period.