Deregulation of Hearing Aids Will Lower Costs and Increase Innovation

(p. A1) The Food and Drug Administration decided on Tuesday to allow hearing aids to be sold over the counter without a prescription to adults, a long-sought wish of consumers frustrated by expensive exams and devices.

The high cost of hearing aids, which are not covered by basic Medicare, has discouraged millions of Americans from buying the devices. Health experts say that untreated hearing loss can contribute to cognitive decline and depression in older people.

Under the F.D.A.’s new rule, people with mild to moderate hearing loss should be able to buy hearing aids online and in retail stores as soon as October, without being required to see a doctor for an exam to get a prescription.

. . .

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

. . .

The change has been percolating for years. In 2016, a proposal for the F.D.A. to approve over-the-counter hearing aids for adults with mild to moderate hearing was released in a report by the National Academies of Science, Engineering and Medicine. The following year, Senators Chuck Grassley, a Republican of Iowa, and Elizabeth Warren, a Democrat of Massachusetts, introduced a bill enabling the agency to make the change. Congress approved the legislation and President Trump signed it into law.

Finalizing regulations has moved slowly since then, with some conflict over details, like how the federal rule would interact with state laws on hearing aid returns or warranty policies and how much the devices should amplify sound.

Mr. Biden issued an executive order last July calling for greater competition in the economy, which urged the F.D.A. to take action “to promote the wide availability of low-cost hearing aids.”

For the full story, see:

Christina Jewett. “F.D.A. Decides to Allow Over-the-Counter Sales of Hearing Aids.” The New York Times (Wednesday, August 17, 2022): A1 & A23.

(Note: ellipses added.)

(Note: the online version of the story was updated Aug. 23, 2022, and has the title “F.D.A. Clears Path for Hearing Aids to Be Sold Over the Counter.”)

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