FDA Proposes Rule To Make OTC Access Of Hearing Aids, Reduce Cost

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The U.S. Food and Drug Administration took an important step towards making hearing aid devices available over the counter at pharmacies and other regular retail stores without needing a prescription, a medical exam, or a fitting.

A landmark proposal that FDA issued Tuesday also intends to reduce the cost of hearing aid technology for millions of Americans.

The agency proposed a rule to establish a new category of over-the-counter (OTC) hearing aids. When finalized, the rule would allow hearing aids within this category to be sold directly to consumers in stores or online without a medical exam or a fitting by an audiologist. This is to help increase competition in the market while also ensuring the safety and effectiveness of OTC and prescription hearing aids.

In an Executive Order on Promoting Competition in the American Economy that he issued in July, President Joe Biden had called for the FDA to take steps to allow hearing aids to be sold over the counter.

"Building on bipartisan legislation led by Secretary Grassley and Senator Warren, the rules issued today will help millions of Americans with mild to moderate hearing loss get cheaper and more convenient access to hearing aids," White House Press Secretary Jen Psaki said.

"The goal is to cut the red tape and allow more companies to compete to sell hearing aids. We're hopeful that the rules will be finalized next year. And with increased competition, expect hearing aids to cost hundreds instead of thousands of dollars," she told reporters at a briefing.

About 15 percent of American adults, or 37.5 million people, have trouble hearing, but just one fifth of them use hearing aids, in part because they're so expensive and inconvenient to get, according to FDA.

The proposed rule aims to address barriers to use, including cost, access, social stigma related to hearing loss, perceived value of the devices or certain state and federal regulations.

The proposed rule would amend existing rules that apply to hearing aids for consistency with the new OTC category, repeal the conditions for sale for hearing aids and address state regulation of hearing aids. The OTC category, when finalized, would apply to certain air-conduction hearing aids intended for adults who have perceived mild to moderate hearing loss.

Hearing aid devices for severe hearing loss or for users younger than age 18 would continue to require prescription.

To ensure patient safety, the proposed rule also addresses a maximum volume output limit for OTC hearing aids that would prevent injuries from overamplification of sound.

Hearing loss can be caused by aging, exposure to loud noises, certain medical conditions and other factors. Individuals with permanent hearing loss can use hearing aids to help make speech and sounds around them louder, enabling more effective communication with others.

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