By Nathalie Voit

The U.S. Food and Drug Administration (FDA) issued a historic ruling on Aug. 16, establishing a new regulatory category for over-the-counter (OTC) hearing devices.

Effective Oct. 17, consumers will no longer need to undergo a medical exam, obtain a prescription, or receive a fitting adjustment by an audiologist to purchase a hearing aid from a store or online retailer.

“Hearing loss is a critical public health issue that affects the ability of millions of Americans to effectively communicate in their daily social interactions,” FDA Commissioner Robert M. Califf said in a statement. “Establishing this new regulatory category will allow people with perceived mild to moderate hearing loss to have convenient access to an array of safe, effective and affordable hearing aids from their neighborhood store or online.”  

As many as 30 million U.S. adults have a serious hearing impairment. The first-of-its-kind ruling essentially fast-tracks the commercial sale of safe and effective OTC hearing devices across retailers nationwide.

The FDA said that consumers could see OTC hearing aids in traditional retail and drug stores as soon as mid-October.

The action is expected to significantly reduce costs for Americans with mild to moderate hearing impairment. The ruling is also expected to promote competition in the hearing aid technology market.

“Reducing health care costs in America has been a priority of mine since Day One, and this rule is expected to help us achieve quality, affordable health care access for millions of Americans in need,” Health and Human Services Secretary Xavier Becerra said in the statement. “Today’s action by the FDA represents a significant milestone in making hearing aids more cost-effective and accessible.”

The ruling is part of President Joe Biden’s broader Executive Order promoting competition in the American economy.