FDA Finalizes Rule To Allow Hearing Aids To Be Sold Over The Counter

By Bill Galluccio

August 16, 2022

Women inserting hearing aid. Medical concept
Photo: Getty Images

The Food and Drug Administration has finalized a rule that will allow hearing aids to be sold over the counter. The new rule "applies to certain air-conduction hearing aids intended for people 18 years of age and older who have perceived mild to moderate hearing impairment."

The FDA said that the move will save consumers thousands of dollars and help roughly 30 million people with hearing loss. People will no longer need to undergo a medical exam to get a hearing aid, and the added competition is expected to drive down costs.

"This could fundamentally change technology," Nicholas Reed, an audiologist at the Department of Epidemiology at Johns Hopkins Bloomberg School of Public Health, told the New York Times. "We don't know what these companies might come up with. We may literally see new ways hearing aids work, how they look."

The agency noted that more powerful hearing aids meant for people with severe hearing impairment will remain available by prescription only.

"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 Health and Human Services Secretary Xavier Becerra. "Today's action by the FDA represents a significant milestone in making hearing aids more cost-effective and accessible."

The FDA said that over-the-counter hearing aids will be available beginning in October.

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