FDA approves over-the-counter hearing aids in bid to lower costs, increase access

The Food and Drug Administration on Tuesday moved to allow the sale of hearing aids without a prescription or audiology exam, a decision designed to make hearing aids cheaper and easier to buy for an estimated 30 million U.S. adults with mild to moderate hearing loss. The over-the-counter hearing aid should be available to consumers as soon as October.

"This action makes good on my commitment to lower costs for American families, delivering nearly $3,000 in savings to American families for a pair of hearing aids and giving people more choices to improve their health and well-being," President Biden said in a statement. Basic Medicare does not cover hearing aids, nor do many private insurance plans. A pair of hearing aids currently costs anywhere from $1,400 to about $5,000.

The new FDA rule, in the works since 2016, was authorized by the Over-the-Counter Hearing Aid Act of 2017, introduced by Sen. Chuck Grassley (R-Iowa) and Sen. Elizabeth Warren (D-Mass.). Former President Donald Trump signed that law, and Biden revived the stalled effort with an executive order in July 2021. The FDA is creating a new category of hearing aids that override state regulations requiring prescriptions, medical exams, and fittings.

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Proponents of the change say it should spark innovation in the consumer hearing aid market, currently dominated by a small number of manufacturers. It will "unleash the power of American industry," FDA Commissioner Dr. Robert Califf predicted. "Hearing loss has a profound impact on daily communication, social interaction, and the overall health and quality of life for millions of Americans," he said at a news briefing. "This is a tremendous worldwide problem where I think American ingenuity can make a huge difference."