FDA Warns Against Marketing OTC Hearing Aids

July 27, 2018

CDRH’s Office of Device Evaluation issued a letter reminding manufacturers not to market hearing aid devices as OTC products until regulations are finalized.

Provisions for regulations in the FDA Reauthorization Act of 2017 that create a category of OTC hearing aids and define their requirements have not yet been instated, so OTC hearing aids remain restricted devices, and their sales must adhere to federal and state requirements, said ODE’s Director William Maisel.

The agency has a deadline of August 18, 2020 to publish the proposed regulations. It will then consider public comments and publish final regulations within 180 days of the end of the comment period.

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