FDA allows over-counter purchase of hearing aids 'Game changer': FDA allows over-counter sales of hearing aids

The decision, prompted by an edict from President Joe Biden to promote economic competition, could result in hearing aids costing hundreds instead of thousands of dollars.

The U.S. Food and Drug Administration will allow adults to buy hearing aids <a href="https://www.fda.gov/news-events/press-announcements/fda-finalizes-historic-rule-enabling-access-over-counter-hearing-aids-millions-americans" target="_blank">over the counter</a>, giving them a low-cost option for addressing mild and moderate hearing loss that affects about 30 million Americans.

The <a href="https://www.federalregister.gov/public-inspection/2022-17230/medical-devices-ear-nose-and-throat-devices-establishing-over-the-counter-hearing-aids" target="_blank">final rule</a> that the FDA issued on Tuesday will take effect in mid-October, allowing anyone 18 or older to buy a hearing aid directly from retailers without an examination or prescription by an audiologist.

The decision, prompted by an edict from President Joe Biden to promote economic competition, could result in hearing aids costing hundreds instead of thousands of dollars.

"It's been a long wait to get somebody to allow this to happen," said Doug Gray, executive director of the <a href="https://www.vahp.org/" target="_blank">Virginia Association of Health Plans</a>. "Now, there's going to be real competition, which is going to help people."

Insurers offer Medicare Advantage plans that cover the cost of hearing aids and care, but Gray said the over-the-counter option will enable people to buy hearing aids without paying a higher health insurance premium.

"I think this is a real opportunity for the marketplace to help consumers to have more and better choices," he said. "This is an example of something that's probably better provided outside of insurance."

Virginia's Medicaid program currently covers the cost of hearing aids for members up to 21 years old, but not adults. Three of Virginia's six Medicaid managed care insurance plans offer hearing aid coverage for adults in the Commonwealth Coordinated Care Plus program, which serves people with high needs.

AARP, which represents 38 million Americans, including 1 million Virginians, said only 1 in 5 people with mild to moderate hearing loss currently use a hearing aid.

"Giving people with mild to moderate hearing loss access to affordable hearing aids is an important step to ensure their health and quality of life," said Nancy LeaMond, the national association's executive vice president and chief advocacy and engagement officer.

"For many Americans, the high cost of prescription hearing aids puts them out of reach, increasing their risk of isolation, depression and other health issues," LeaMond said on Tuesday. "Today's rule could help millions."

The FDA action came after Biden issued an executive order last summer on "Promoting Competition in the American Economy" that directed the agency to take steps to permit over-the-counter sales of hearing aids. Congress passed bipartisan legislation five years ago to create a new category of hearing aids that could be sold over the counter, but it had not been fully implemented.

"Today's action by the FDA represents a significant milestone in making hearing aids more cost-effective and accessible," Secretary of Health and Human Services Xavier Becerra said in a statement on Tuesday.

The administration said its goal was to ensure the "safety and effectiveness" of hearing aids sold over the counter, "while fostering innovation and competition in the hearing aid technology marketplace."

"Hearing loss is a critical public health issue that affects the ability of millions of Americans" to effectively communicate "in their daily social interactions," Dr. Robert M. Califf, the FDA commissioner, said on Tuesday.

"Establishing this new regulatory category will allow people with perceived mild to moderate hearing loss to have convenient access to an array of safe, effective and affordable hearing aids from their neighborhood store or online," Califf said.

The FDA had proposed a new rule last October, but adjusted the regulations after receiving more than 1,000 comments from a wide array of interests - consumers, professional associations, manufacturers, public health organizations and advocates, state agencies and members of Congress.

The final rule lowers the maximum sound output to reduce risk of damage from over-amplification, revises the depth limit for inserting the device into the ear, requires user-adjustable volume control and clear instruction on product labeling to make it easier to understand. The final rule also sets performance specifications and device design requirements.

The agency also issued guidance to help consumers understand the differences between hearing aids - considered medical devices - and "personal sound amplification products" designed to boost sound for people with normal hearing.

"It is a game changer for people who are comfortable with the technology and can get used to it," said Gray with the state health plan association.

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