Hearing aids without a prescription or an exam? The FDA takes big step toward making that happen. [View all]

[BumRushDaShow]

Source: Washington Post

A long-awaited Food and Drug Administration proposal would allow millions of consumers to buy over-the-counter hearing aids in stores or online without a prescription or medical exam. More than four years after Congress ordered the agency to allow over-the-counter hearing aids, it took the first step Tuesday to broaden access to more accessible and affordable devices for millions of patients with mild to moderate hearing loss. The agency’s proposal would create a new category of over-the-counter hearing aids and supersede state-level regulations that require patients to go through physicians or audiologists to get prescriptions and fittings for them.

Hearing aids cost an average more than $5,000 per pair, are not typically covered by traditional Medicare or other insurers, while advocates argue that over-the-counter models could be a fraction of that cost. “Reducing health care costs for everyone in America is a top priority,” said Health and Human Services Secretary Xavier Becerra said in a statement on Tuesday. “Today’s move by FDA takes us one step closer to the goal of making hearing aids more accessible and affordable for the tens of millions of people who experience mild to moderate hearing loss.”

Although 15 percent of adults in the United States report having some trouble hearing, according to the National Institute on Deafness and Other Communication Disorders, only about 1 in 5 use hearing aids. Cost and stigma associated with the medical devices stand in the way of some patients’ access. “More than 30 million people suffer from some sort of hearing loss and hearing is so vital to what we do, your ability to communicate with others is a huge part of your quality of life,” said Vinay Rathi, a physician at Massachusetts Eye and Ear. “We’re really denying people that sort of basic right, which is the ability to communicate with others, because of issues related to cost and access to audiologists."

The FDA said on Tuesday that its new rule aims to spark innovation and increase competition by lowering barriers for new companies to enter the market while simultaneously regulating the new category of over-the-counter hearing aids to ensure the devices are safe and effective. “Over the years, our number one call, email [and] letter is from people who can’t afford hearing aids, or they don’t have access to an audiologist or hearing aid specialist," said Barbara Kelley, executive director of the Hearing Loss Association of America. “Now, not all of those people would benefit from an over-the-counter product. We know that. But … this is going to help those people who might be able to benefit.”


Read more: https://www.washingtonpost.com/health/2021/10/19/fda-over-the-counter-hearing-aids/

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Well as a medical device with so much technology innovation due to miniaturization that has happened over the past couple decades, one would think this is do-able (at least with enough surveillance and testing of such as a faulty speaker could damage the ear drum).

There have been "reading glasses" (magnifiers) sold OTC for many many years and they are exempt from certain FDA device regs (although manufacturers/importers still must be registered).