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FDA Releases Proposed Rule for OTC Hearing Aids

October 19, 2021

Today, the Food and Drug Administration (FDA) announced the release of the agency’s proposed rule for over-the-counter (OTC) hearing aids that will provide the framework for the sale and purchase of OTC hearing aids to adults age 18 and older with perceived mild to moderate hearing loss. ASHA will carefully review the regulations, which will be officially published tomorrow, and develop comments with input from ASHA members and subject matter experts. ASHA has been working with the FDA and Congress on this issue for several years because we know how important these regulations are to our members. We are working as quickly as possible to assess the regulations and will issue a thorough analysis as soon as possible.

The Over-the-Counter Hearing Aid Act of 2017 directs the FDA to issue regulations for a new category of OTC hearing aids that provide reasonable assurances of the safety and effectiveness for adults age 18 and older with perceived mild to moderate hearing impairment. ASHA, the American Academy of Audiology (AAA), the Academy of Doctors of Audiology (ADA), and the International Hearing Society released a consensus paper, "Regulatory Recommendations for OTC Hearing Aids: Safety and Effectiveness," to provide guidance to the FDA as it develops an OTC hearing device category and related regulations. The FDA’s announcement follows President Biden’s Executive Order calling on the U.S. Department of Health and Human Services “to consider issuing proposed rules within 120 days for allowing hearing aids to be sold over the counter.”

Questions?

Contact Bill Knudsen, ASHA’s director of education policy, at bknudsen@asha.org.


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