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The US Food and Drug Administration issued a proposal Tuesday to create a new class of over-the-counter hearing aids in an effort to improve accessibility and lower costs for millions of Americans.

Once finalized, the rules will allow hearing aids to be sold to consumers in stores and online without a medical examination or fitting by an audiologist. This will apply to certain air-conducting hearing aids intended for adults 18 years of age and older with mild to moderate hearing loss.


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A prescription will still be needed for hearing aids for severe hearing loss and for those under the age of 18.

“Reducing health care costs for all is a top priority in America,” said Health and Human Services Secretary Javier Becerra. “The FDA’s move today takes us one step closer to the goal of making hearing aids more accessible and affordable for the millions of people who experience mild to moderate hearing loss.”

The FDA proposal enforces a provision of the Over-the-Counter Hearing Aid Act, which was part of the 2017 FDA Beautification Act.

This May 2010 photo shows 10-year-old Zahra Baker receiving a hearing aid at an event at Charlotte Motor Speedway.

The FDA said that about 37.5 million Americans have some degree of hearing loss. Only one-fifth of them use hearing aids.

The agency said the rule aims to remove barriers such as cost and social stigma related to hearing loss.

“The rule aims to facilitate innovation and increase competition by lowering barriers to entry for new hearing aid manufacturers,” it said.

The Food and Drug Administration issued a resolution Tuesday in an effort to provide over-the-counter hearing aids.

Censors Elizabeth Warren, D-Mass., and Chuck Grassley, R-Iowa. hailed the FDA’s action, calling it “excellent news.”

“We have just cleared a major regulatory hurdle for over-the-counter hearing aids,” the senators said in a joint statement. “Soon, millions of people with mild to moderate hearing loss will eventually have low-cost hearing aid options – and more options means more competition in the market, further reducing costs for consumers.”

Both lawmakers sent the FDA Letter Last week without delay called for regulations for over-the-counter hearing aids.