By Edward C. Baig, AARP, September 2024
FDA Approves Software to Turn Some AirPods Into Hearing Aids. Latest pro model of Apple earbuds will help adults with mild to moderate hearing loss. A software update for Apple AirPods Pro 2, which the FDA approved Sept. 12, 2024, will allow them to also become clinical-grade OTC hearing aids.
Some Apple AirPod earbuds, which people of all ages use to listen to music and podcasts or chat over the phone, soon will have a new purpose — to help adults hear better.
On Thursday, the Food and Drug Administration (FDA) gave its approval to the first-ever over-the-counter (OTC) hearing aid software, which will make that happen for Apple’s $249 AirPods Pro 2. The OK came three days after Apple announced the model would be able to double as a clinical-grade OTC hearing aid.
The FDA put OTC hearing aid regulations in place in October 2022 to help lower prices for hearing aids overall and to simplify the buying process for consumers. Such hearing aids are sold online or at retail without requiring a prescription from an audiologist or hearing professional.
As with other OTC hearing aids, these AirPods are for people with mild or moderate hearing loss, not those with more severe hearing issues. Apple’s hearing aid feature will arrive this fall in a software update for the earbuds and as part of the iOS 18 update for the iPhone.
“If we’re now entering a world where people are talking in a restaurant and putting on AirPods and overcoming the background noise in the situation they need, we are really changing the face of … hearing augmentation,” says audiologist Nicholas Salvatore Reed, associate professor at the Optimal Aging Institute at NYU Langone Medical Center and coauthor of AARP’s Hearing Loss for Dummies.
Hearing loss often goes untreated
Hearing loss is a chronic issue that typically worsens with age. More than 1.5 billion people globally live with some form of hearing loss, according to the World Health Organization, the vast majority with mild to moderate problems.
In the United States, about 1 in 3 people ages 65 to 74 have some sort of hearing loss. That rises to nearly half for adults 75 and older, according to the National Institutes of Health (NIH).
And yet very few people get treated, much less wear hearing aids that might help them. Last year, the National Council on Aging reported that just 1 in 6 Americans with hearing loss wear hearing aids.
Untreated hearing loss can increase the risks of dementia.
About 4 in 5 U.S. adults have not had their hearing checked in the past five years, according to Apple. And 75 percent of people who participated in an Apple Hearing Study conducted in collaboration with the University of Michigan School of Public Health and the World Health Organization and were diagnosed with hearing loss haven’t received the help they need.
Reasons people don’t like hearing aids
Comfort and cost have been major barriers. Traditional hearing aids can set you back several thousand dollars, Medicare doesn’t cover them, and people may be reluctant to go through a series of fittings with an audiologist.
And then comes the stigma: Wearing something in the ears gives off the vibe that the users are, well, old.
The concern is not unfounded. Nearly 1 in 5 of adults older than 40 think society negatively judges people who use hearing aids, according to a 2023 AARP report on social stigma and health conditions. Ironically, AirPods and rival earbuds from competitors that include Bose, Google, Samsung, Sony and Soundcore, mean more people are accustomed to seeing folks with stuff in their ears.
“Apple is a sexy brand and a known brand,” so that may reduce the stigma, Reed says.
Other companies sell, poised to sell devices to help hearing
Companies such as Eargo and Jabra Enhance sell nonprescription hearing aids designed to be mostly invisible inside the ears.
At the CES tech industry trade show in January, Italy and France’s EssilorLuxottica demonstrated prototypes of ordinary-looking eyeglasses that amplify sound through microphones in the frame and deliver that sound to the wearer through tiny speakers.
The company says these Nuance Audio glasses, as they’re branded, are on track to debut by the end of 2024. These also will require the FDA’s blessing.
While Apple designs pretty much everything in-house, other familiar tech brands in the OTC market have teamed up with traditional hearing aid companies. Sony partnered with Danish hearing loss company WS Audiology, and Sennheiser’s consumer division was bought by Sonova, whose other hearing aid brands include Phonak. Bose powers Lexie hearing aids.
OTC hearing aids haven’t lived up to expectations
OTC hearing aids haven’t delivered as much as hoped to people with mild to moderate hearing loss in the nearly two years since the FDA approved the first of them. Lots of companies make OTC hearing aids, with varying quality, some with little customer support.
“I think there’s a lot of confusion, especially at the consumer level,” says audiology consultant Thomas Powers, who founded Powers Consulting in Oxford, New Jersey. Powers told AARP he’s hearing about return rates in the OTC space of 35 to 50 percent.
To keep that from happening to you, hearing professionals recommend:
Reading reviews from reputable outlets before deciding on a model.
Finding out the return policies and what customer service you can expect.
Being patient in the first weeks as you get used to wearing the new hearing aids.
How Apple says it will protect its AirPod wearers
Apple says features within its iPhone and earbuds will protect AirPods Pro 2 wearers. Through a hearing protection feature turned on by default, the tips on the earbuds help provide “passive” noise reduction, and an Apple-designed chip in the earbuds reduces louder, intermittent noises at 48,000 times per second.
The company also is adding what it says is a clinically validated hearing test you would take on an iPhone or iPad while wearing the AirPods Pro 2. You’re asked to tap the phone screen when you hear a series of tones at different volumes and frequencies.
The test, which Apple says takes about five minutes, was based on data from the Apple Hearing Study. Results, which include recommendations and an audiogram, will be securely stored in the Health app on the iPhone, though you’ll be able to share them with a health care provider.
Apple says your hearing profile can help customize the listening experience on the AirPods Pro 2.
Several hearing aid manufacturers offer online hearing tests, and Medicare also covers exams to diagnose hearing problems. AARP members can take a hearing test for free at the National Hearing Test website, developed in conjunction with the NIH.
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