In your pocket or purse, you may be toting around small devices that, with the help of new software authorized by the Food and Drug Administration, could soon become inexpensive hearing aids. Millions of people already own them.
They’re Apple’s AirPods Pro 2, those white plastic knobs protruding from so many ears in malls and workplaces, on buses and sidewalks. The users may not be among the 30 million American adults reporting some degree of hearing loss; they’re probably just listening to music or podcasts, or talking on their phones.
Within weeks, however, consumers will be able to use those AirPods Pro 2 earbuds to bolster their hearing. Last month, Apple software called Hearing Aid and Hearing Test received a green light from the F.D.A., a first for the regulatory agency.
With the upcoming software and a compatible iPhone or iPad, users will be able test their hearing. For those with mild-to-moderate hearing loss, the AirPods Pro 2 will adjust sounds in their environments and on their devices.
Users will be able to customize their AirPods for volume, tone and balance. All that should allow them to hear better — at least for the devices’ roughly five to six hours of battery life.
Apple plans to release the free software later this fall for iPhones running iOS 18 or later and iPads running iPadOS 18 or later, a spokesperson said. A set of AirPods Pro 2 costs $249 from Apple, and less at big box stores or through online retailers.
This is what reformers had in mind when Congress directed the F.D.A. in 2017 to develop regulations for quality over-the-counter hearing aids.
The idea was to change the existing gatekeeper model, in which people could acquire prescription aids only through licensed professionals for several thousand dollars a pair. Instead, over-the-counter hearing aids that could benefit a majority of the people with hearing loss would be available for a few hundred dollars at any CVS or Walmart, no audiologist or prescription required.
The F.D.A. had three years to develop those regulations; it took five. Finally, two years ago, the hearing health world braced for a transformation — one that still hasn’t quite happened.
“We have no evidence that O.T.C. hearing aids have dramatically changed the hearing market,” said Nicholas Reed, an audiologist and epidemiologist at NYU Langone Health.
“Two years in, I would have thought we’d see a nice bump by now” in the number of people owning hearing aids, he added.
But the most recent National Health and Aging Trends study shows that although about two-thirds of Americans in their 70s and older have some degree of hearing loss, fewer than 30 percent have hearing aids, a fairly consistent finding. Among Black, Hispanic and low-income seniors, ownership rates are even lower.
“Hearing loss is so gradual, a lot of people don’t realize they have it,” said Andy Sabin, a hearing scientist and scientific consultant to HearAdvisor, which tests and evaluates hearing aids.
In fact, a regular survey by the Hearing Industries Association shows that it takes years for people who recognize they have hearing difficulties to buy a hearing aid, if they do at all.
But perhaps because of recent educational campaigns, that delay in seeking treatment has shrunk, from six years in the 2019 survey to four years in 2022. And now the entrance of Apple, a high-profile consumer company, into the O.T.C. market might hasten such changes.
“That moment when they hear better” — and realize that birds are chirping outside the window — “a light goes on. And now that moment will be so much more accessible,” Dr. Sabin said. Like others in the field, he anticipates that more manufacturers and software developers will follow Apple’s lead.
“The way the F.D.A. works, once the first company is through the door, being the second one is so much easier,” Dr. Sabin said.
“We expect lots of other companies will also introduce hearing aid features in their earbuds,” he added. (In his day job, Dr. Sabin is an engineer at Bose, whose technology is already used in a brand of O.T.C. hearing aids.)
The F.D.A. said it couldn’t disclose details of pending product applications.
Concern about older Americans’ hearing reflects a wave of research showing how crucial it is to physical and cognitive health. In 2020, a Lancet commission identified untreated hearing loss as the single greatest potentially modifiable risk factor for dementia.
Last year, researchers reported that among study participants who were older and less affluent, and thus more at risk, hearing aid use slowed the rate of cognitive decline by 48 percent over three years. Untreated hearing loss also increases the risks of social isolation and depression, and it is associated with falls.
So why haven’t more older Americans embraced over-the-counter hearing aids?
Price remains a factor. The F.D.A. has authorized 10 brands of better-quality hearing aids (labeled “self-fitting”) in the last two years, and they usually run $800 to $1,000. Traditional Medicare doesn’t cover hearing aids, and although some Medicare Advantage plans provide hearing benefits, beneficiaries still wind up paying most of the tab themselves.
Beyond the high prices, “we know consumers are still confused about the choices out there and whom to see and when,” said Bridget Dobyan, the executive director of the Hearing Industries Association, which is the main lobbying organization for hearing aid manufacturers.
“When you type in ‘O.T.C. hearing aids’ on Amazon, hundreds of products come up, and some of them cost $1,000 and some cost $100,” said Dr. Reed. “How is a consumer supposed to navigate this market?”
Devices not identified as “self-fitting” are registered with the F.D.A., but manufacturers don’t have to submit evidence of their real-world effectiveness. Those that cost less than $250 “are probably junk,” Dr. Sabin said.
Though consumers can’t try the new software yet, Apple is “a well-known, trusted company” with global brand awareness, Dr. Reed added. That might induce more people with mild-to-moderate hearing loss — the cohort the Apple software is intended for — to become de facto hearing aid owners.
Another advantage: Earbud use isn’t age-specific, possibly reducing the stigma of conventional hearing aids. Nobody will know whether an earbud wearer is listening to Arcade Fire or trying to understand a conversation.
“People want to wear AirPods — my kids would want them,” Dr. Reed said. “That attitude shift is a big deal.”
It might also encourage earlier use, he added, since “you can start using something every now and then in your 40s and 50s, before you really need it in your 60s and 70s,” when hearing loss accelerates.
AirPods-as-hearing-aids will have disadvantages, too. They won’t be as powerful or sophisticated as prescription aids, and they are not intended for those with severe hearing loss. They won’t work for all-day wear, either. “You’d have to use them episodically,” Dr. Sabin said.
Another potential downside of using the AirPods Pro 2: It can take several weeks to adjust to a hearing aid. Apple requires returns within 14 days, and it also charges a fee to replace lost AirPods, which is not an uncommon problem. Other makers of self-fitting O.T.C. devices have varying return policies, but several allow 45 days and their warranties may cover loss or damage replacement (typically for an additional charge).
Also, the Hearing Aid feature requires a later-model iPhone, which will cost $800 to $1,200, or iPad, which costs between $349 and $999.
People with mild to moderate hearing loss who aren’t already Apple product owners could buy prescription hearing aids at Costco instead, where devices start at $1,500 and have better warranty and return policies.
Still, advocates who for years have pushed for more accessible and affordable hearing aids sound genuinely excited.
“This is what we were hoping for — technological innovation,” said Barbara Kelley, executive director of the Hearing Loss Association of America. “When Apple makes a splash, it pushes the idea of hearing health into the mainstream.”
