With the help of new software authorised by the US Food and Drug Administration, everyday devices, already owned by millions of people, could soon become inexpensive hearing aids.
Within weeks, consumers will be able to use Apple’s AirPods Pro 2 earbuds to bolster their hearing, after getting the green light from the FDA last month.
The Apple Hearing Aid and Hearing Test software, in conjunction with a compatible iPhone or iPad, will allow users to 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 customise their AirPods for volume, tone and balance, which should allow them to hear better – at least for the devices’ roughly five to six hours of battery life.
Apple will release the free software within the next few months for iPhones running iOS 18 and iPads running iPadOS 18, a spokesperson said.
A set of AirPods Pro 2 costs $249 from Apple, and less at big box stores or through online retailers, which is what reformers had in mind when Congress directed the FDA 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 devices that could benefit a majority of the people with hearing loss would be available for a few hundred dollars at retailers, with no audiologist or prescription required.
The FDA 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 OTC hearing aids have dramatically changed the hearing market,” said Nicholas Reed, an audiologist and epidemiologist at NYU Langone Health.
“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 Ageing Trends study shows that although about two-thirds of Americans in their 70s and older have some degree of hearing loss, fewer than 30% 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 realise 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 recognise 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 into the OTC market might hasten such changes.
“That moment they hear better – and realise that birds are chirping outside the window –a light goes on. And now that moment will be so much more accessible,” Sabin said. Like others in the field, he anticipates that more manufacturers and software developers will follow Apple’s lead.
“The way the FDA works, once the first company is through the door, being the second one is so much easier.”
In his day job, Sabin is an engineer at Bose, whose technology is already used in a brand of OTC hearing aids.
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% over three years. Untreated hearing loss also increases the risks of social isolation and depression, and is associated with falls.
Beyond the high prices of hearing aids, consumers are still confused about the choices out there and whom to see and when, according to Bridget Dobyan, executive director of the Hearing Industries Association, which is the main lobbying organisation for hearing aid manufacturers.
“When you type in ‘OTC hearing aids’ on the internet, hundreds of products come up, and some of them cost $1 000 and some cost $100,” said Reed. “How is a consumer supposed to navigate this market?”
Devices not identified as “self-fitting” are registered with the FDA, but manufacturers don’t have to submit evidence of their real-world effectiveness. Those that cost less than $250 “are probably junk”, Sabin said.
Though consumers can’t try the new software yet, Apple is “a well-known, trusted company” with global brand awareness, Reed added. That might induce more people with mild-to-moderate hearing loss, the cohort for which the Apple software is intended, to become de facto hearing aid owners.
“People want to wear AirPods – my kids would want them,” Reed said. “That attitude shift is a big deal.”
However, Sabin cautioned that AirPods-as-hearing-aids would not be as powerful or sophisticated as prescription aids, and 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,” Sabin said.
Another potential downside of using the AirPods Pro 2 is that 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.
And the Hearing Aid feature requires a later-model iPhone or iPad.
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.”
See more from MedicalBrief archives:
FDA approves over-the-counter hearing aids for Americans
Hearing aids linked to reduced risk of mental decline and falls but few get them
Some hearing assistance devices perform as well as hearing aids