HLAA Webinar: The FDA Regulations for Over-the-Counter (OTC) Hearing Aids

November 08, 2022



This webinar provides an overview of the key points of the regulation and how this may affect availability and access of both over-the-counter (OTC) and prescription hearing aids. In addition, it provides suggestions on determining your hearing loss, accessing assistance from hearing professionals and key features to consider when purchasing OTC hearing aids. On October 17, 2022, the FDA regulations on over-the-counter (OTC) hearing aids went into effect, creating a new category of hearing devices that can be safely sold to adults 18 years of age and older with perceived mild to moderate hearing loss without the intervention of a hearing professional. These devices will be referred to as OTC hearing aids. In addition, the FDA will now refer to traditional hearing aids as prescription hearing aids. The regulations provide for technical and safety guidelines for those manufacturers who wish to make OTC hearing aids. This new pathway may empower consumers seeking to take responsibility for their own hearing loss. At the same time, education will be needed to help consumers find OTC hearing aids that work for them.


Tom Powers

Thomas Powers, Ph.D.

Founder/Managing Member, Powers Consulting and Strategic Adviser, Hearing Industries Association

Thomas A. Powers, Ph.D., provides management consulting to the hearing health industry. Dr. Powers serves as an expert audiology consultant and strategic adviser for the Hearing Industries Association, and limited partner in RemotEar, LLC. Dr. Powers received his B.S. from the State University of New York at Geneseo, and his... Read More >