Academy of Doctors of Audiology
August 15, 2022
FDA Final OTC Hearing Aid Rule Released with 60-Day Effective Date
Posted in: All News

Today, the U.S. Food and Drug Administration released its long-awaited Final Over-the-Counter (OTC) Hearing Aid Rule (Final Rule) nearly five years after the Over-the-Counter (OTC) Hearing Aid Act was signed into law.

The Academy of Doctors of Audiology (ADA), a longstanding proponent of OTC hearing aids, commends the FDA for including provisions in the Final Rule that provide reasonable assurance of safety and efficacy for adult consumers with perceived mild-to-moderate hearing loss, and that are consistent with Congress’ directive.

“ADA applauds Senator Elizabeth Warren (D-MA) and Senator Grassley (R-IA) for their commitment to improve access to hearing aids and to audiology services through their efforts to enact and implement the OTC Hearing Aid Act, and their efforts to advance the Medicare Audiologist Access and Services Act through Congress,” said ADA President Kristin Davis, Au.D.

ADA will continue to evaluate the provisions contained in the Final Rule to determine the potential impact to members as it relates to state licensure laws, competition, and transparency, particularly with regard to the newly created category of prescription hearing aids.