FDA Issues Final Rule Establishing New Category of OTC Hearing Aids

The US Food and Drug Administration (FDA) established a new category of over-the-counter (OTC) hearing aids which will enable consumers to purchase the devices without a prescription. The FDA announced the final rule in a press release.

The FDA anticipates the rule will encourage innovation and market competition in the hearing aid technology space while reducing costs and access barriers for consumers. In addition to not needing a prescription, individuals with mild to moderate hearing impairment will be able to purchase hearing aids without a medical examination or fitting adjustment by an audiologist.

“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,” said Xavier Becerra, secretary, US Department of Health and Human Services, in the press release. “Today’s action by the FDA represents a significant milestone in making hearing aids more cost effective and accessible.”

Under the new rule, certain air-conduction hearing aids for adults with mild to moderate hearing impairment will be eligible for sale over the counter, but prescription devices intended for those younger than 18 years of age or with more severe hearing impairment will not be included.

Per the press release, an estimated 30 million US adults could benefit from using hearing aids.

“Hearing loss is a critical public health issue that affects the ability of millions of Americans to effectively communicate in their daily social interactions,” said FDA Commissioner Robert M Califf, MD. “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 final rule was issued on the heels of President Biden’s Executive Order on Promoting Competition in the American Economy, which established a deadline for the FDA to make hearing aids accessible over the counter.

The final rule modifies aspects of the proposed rule, which was announced in October 2021. Among other changes, the FDA lowered the maximum sound output of the hearing aids, revised the insertion depth limit in the ear canal, and required all OTC hearing aids to include user-adjustable volume control. The FDA also issued guidance to clarify the differences between hearing aids and personal sound amplification products.

According to the press release, the FDA anticipates OTC hearing aids could become broadly available to the public as soon as mid-October 2022.

Reference:
US Food and Drug Administration. FDA finalizes historic rule enabling access to over-the-counter hearing aids for millions of Americans. News release. US Food and Drug Administration; August 16, 2022.