FDA issues final rule enabling access to OTC hearing aids

The FDA in August issued a final rule to establish a new category of over-the-counter hearing aids, which will enable consumers with perceived mild to moderate hearing impairment to purchase hearing aids directly from stores or online retailers.

According to an FDA press release, the rule follows President Joe Biden’s July 2021 Executive Order on Promoting Competition in the American Economy, which urged the FDA to take steps to permit the sale of OTC hearing aids. The rule is expected to lower the cost of hearing aids while assuring the safety and effectiveness of OTC hearing aids and promoting innovation and competition in the marketplace.

“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,” HHS Secretary Xavier Becerra said in the release. “[The] action by the FDA represents a significant milestone in making hearing aids more cost-effective and accessible.”

According to the release, roughly 30 million American adults could benefit from hearing aid use. The final rule will allow consumers to purchase hearing aids without the need for a medical examination, prescription or fitting adjustment by an audiologist.

“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, MD, said in the release. “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.”

The FDA finalized the rule after receiving and reviewing more than 1,000 public comments on the proposed rule issued on Oct. 20, 2021. In response, the final rule incorporates several changes from the proposed rule, including lowering the maximum sound output, revising the insertion depth limit in the ear canal, requiring all OTC aids to have user-adjustable volume control and simplifying the phrasing of the device labeling for ease of understanding.

The final rule is slated to go into effect Oct. 17.