The idea of hearing aids being sold over the counter started back in 2017 when large concerns about the accessibility and affordability of these devices for consumers were circulating. The Academy worked closely on this issue by organizing board members, creating working groups, lobbying on Capital Hill, drafting regulatory comments, and creating resources for members to be prepared.
Legislation
In August 2017, the Over-the-Counter(OTC) Hearing Aid Act was signed into law as part of the Food and Drug Administration (FDA) Reauthorization Act, also known as FDAR. This legislation directed the FDA to create a new category of over-the-counter hearing aids for adults with perceived mild to moderate hearing loss. The provisions of the OTC Hearing Aid Act implement major recommendations from the President’s Council of Advisors on Science and Technology (PCAST) and the National Academies of Science, Engineering, and Medicine (NASEM).
Regulations
The FDA released the proposed rule for regulation of OTC hearing aids on October 20, 2021.
The Academy formed a subject matter expert work group comprised of members to analyze the proposed rule to prepare comments. The Academy board reviewed and approved the final comments and submitted the comments to the FDA on December 8, 2021.
OTC Hearing Aids FAQs
Consensus Document
In 2018, The Academy teamed up with other members of the hearing health community to draft consensus recommendations for this new class of devices. The consensus recommendations address several areas of concern which include, but are not limited, to appropriate product requirements for devices targeting mild to moderate hearing loss, outside-of-the-box labeling, comprehensive inside-the-box labeling, and establishing strong consumer protection laws.
Access Additional OTC Hearing Aid Resources
Consumers and OTC Hearing Aid Resources
Children and OTC Hearing Aid Resources
The OTC Hearing Aid Final Rule: Implications for Audiology Webinar On Demand
American Academy of Audiology Position Statement – The Role of Audiologists with OTC Hearing Aids
FDA Proposed Rule: Medical Devices, ENT Devices, and OTC Hearing Aids – Top-Level Summary
