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

Hearing aids
(Image credit: Joe Raedle/Getty Images)

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.

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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."

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Peter Weber, The Week US

Peter has worked as a news and culture writer and editor at The Week since the site's launch in 2008. He covers politics, world affairs, religion and cultural currents. His journalism career began as a copy editor at a financial newswire and has included editorial positions at The New York Times Magazine, Facts on File, and Oregon State University.