New Over-the-Counter Hearing Aids a 'Game Changer' for Millions of Americans

It's thought that 90% of the U.S. population with hearing loss could benefit from the introduction of over-the-counter hearing aids

Hand holding hearing aid
Photo: Getty Images/Johner RF

Over-the-counter hearing aids became available to buy in the U.S. Monday, and are being looked at as a big victory for people with hearing loss.

Thanks to their introduction, adults who think they have mild to moderate hearing impairment don't need to see a doctor first in order to buy hearing aids.

It comes as a result of a long-awaited Food and Drug Administration rule change in August that allowed millions of Americans to buy the product "without the need for a medical exam, prescription or a fitting adjustment by an audiologist," per an FDA release.

"Reducing health care costs in America has been a priority of mine since Day One and this rule is expected to help us achieve quality, affordable health care access for millions of Americans in need," Health and Human Services Secretary Xavier Becerra said in the August release. "Today's action by the FDA represents a significant milestone in making hearing aids more cost-effective and accessible."

Macro close up of a matched pair of tiny modern hearing aid
Getty Images/iStockphoto

The action, which followed President Biden's Executive Order on Promoting Competition in the American Economy, removes the need for a custom fitting beforehand. CNN reported that 90% of the population with hearing loss could benefit from over-the-counter hearing aids and that experts are calling it a "game changer" in health care, per CNN.

Roughly 16% of people with hearing loss — 1 in 8 people in the U.S. over the age of 12, and about 25% of people aged 65 to 74 — use a hearing aid, according to the National Institute on Deafness and Other Communication Disorders.

The Medical journal JAMA published a study that estimates people with hearing difficulties spend an average of $4,000 on aids, per CNN.

"We've been working for years for affordable and accessible hearing health care," Barbara Kelley, executive director of the Hearing Loss Association of America, told CNN. "We're really looking forward to Monday."

While Americans can still see a doctor to get a hearing aid, the hope is that the new initiative will enable people to receive help faster and more cheaply. Until now, people have often had to "wait five to seven years before they get a hearing aid," HLAA executive director Barbara Kelley told NPR.

"So if this would inspire people or motivate people because they see these hearing aids in the mainstream, that should be more affordable or at a different price point, they might take that first step sooner rather than later," she said.

Medicare and health insurances typically do not cover hearing aid costs, with the White House estimating that people can save upwards of $3,000 through the new plan, calling it "the latest action we are taking to make our economy more competitive and less concentrated."

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"This will allow companies like Samsung, Apple, Google – companies that are already making innovative earbuds – they can now enter the market," Dr. Frank Lin, director of the Cochlear Center for Hearing and Public Health, told CNN. "They really couldn't before."

Kate Carr, president of the Hearing Industries Association, told NPR that hearing aids aren't always that pricey. And now they won't have to be, as Walgreens will sell Lexie Lumen hearing aids for $799 and Walmart will offer them over-the-counter for $200.

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