FDA moves to make over-the-counter hearing aids available to millions

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The Food and Drug Administration on Tuesday moved to make hearing aids cheaper and easier to buy over the counter without a prescription or medical exam — a long-awaited goal for nearly 30 million consumers.

“As early as mid-October, Americans will be able to purchase more affordable hearing aids over the counter at pharmacies and stores across the country,” President Biden said in a statement Tuesday. “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.”

The president called on the FDA to make hearing aids available over the counter last year in his Promoting Competition in the American Economy executive order to lower costs and increase competition in certain industries.

The new regulations will create a new category of hearing aids that supersede state-level regulations requiring patients to visit physiciansor audiologists to get prescriptions and fittings. The devices will be available for individuals 18 and older with mild to moderate hearing loss at pharmacies, stores and online.

Sen. Elizabeth Warren (D-Mass.), a co-sponsor of the Over-the-Counter Hearing Aid Act, praised the decision on Twitter and credited Biden with moving the issue forward after it stalled at FDA.

“It took years of hard work, but I’m glad that millions of Americans — many of whom aren’t using hearing aids because they are too expensive — will soon be able to buy safe & affordable hearing aids over the counter,” she tweeted. “This is what it looks like when government works for working people.”

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