FDA to allow over-the-counter hearing aids for first time

The Food and Drug Administration (FDA) announced on Tuesday that it would let some hearing aids be sold over-the-counter for the first time.

The move is expected to affect millions of Americans. Currently, 15% of American adults (37.5 million people) report trouble hearing.

As of now, cost is a major obstacle for many people who could benefit from hearing aids. Americans can pay more than $5,000 for a hearing aid, insurance coverage is limited, and Medicare doesn’t pay for hearing aids, reports the Associated Press.

“The requirement to see a specialist was not only a burden and an annoyance for many consumers, but it actually created a competitive barrier to entry,” said Brian Deese, a White House economic adviser.

The move has been years in the making, reports the New York Times. In 2016, the National Academies of Science, Engineering and Medicine released a report proposing that the FDA approve over-the-counter hearing aids. In 2017, Senators Chuck Grassley (R-Iowa) and Elizabeth Warren (D-Mass) introduced a bill enabling the FDA to make the change. Once the bill passed Congress, President Trump signed it into law.

Startups and established companies alike are expected to rush into the newly-opened market.

“I’m confident that we will see a significant reduction in prices for consumers with mild to moderate hearing loss,” said Blake Cadwell, founder and CEO of Soundly, a site that allows people to shop for hearing aids online.

“This could fundamentally change technology,” said Nicholas Reed, an audiologist at the Department of Epidemiology at Johns Hopkins Bloomberg School of Public Health. “We don’t know what these companies might come up with. We may literally see new ways hearing aids work, how they look.”

Investors, in anticipation of this ruling, have been pouring money into this area over the past several years. Fast Company reports that last year, hearing company Olive Union landed $7 million in venture-capital funding. And in 2020, Eargo announced $71 million in financing after debuting its innovative hearing aid.

“Hearing loss is a critical public health issue that affects the ability of millions of Americans to effectively communicate in their daily social interactions,” FDA Commissioner Robert M. Califf said in a statement. “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.”