When over-the-counter (OTC) hearing aids debuted two years ago, Justin S. Golub, MD, MS, an otology specialist and associate professor of otolaryngology–head and neck surgery at Columbia University in New York, was enthusiastic. Here was a chance to give greater accessibility to a huge swath of people with mild to moderate hearing loss who could really benefit from assistance with their hearing but who are not inclined to go through the whole process of being examined and then fitted for a prescription hearing aid.
Dr. Golub—along with the wider otolaryngology community—thought it was a great opportunity.
At the same time, he looked around at all the people wearing white Apple earbuds for their phone calls and music—on city streets, in subways, in shops and restaurants—and he thought, Hmm, maybe those could be used as hearing aids, too.
With Apple’s recent announcement that the AirPods Pro 2 will gain a function as a hearing aid—as well as a hearing test—Dr. Golub and other hearing specialists have gotten their wish.
“This Apple announcement, in my opinion, is the most exciting thing to happen since over-the-counter hearing aids came out about two years ago,” he said. “From the very beginning, we were hoping that Apple would enter the market. They finally now have.”
The hearing aid news came alongside an announcement that the Apple Watch will now be able to track breathing disturbances and alert users that they may have sleep apnea.
The tech behemoth’s grand strides into the hearing aid and sleep apnea arena are major milestones in the increasing “over-the-counterization” of otolaryngology care, joining the already available no-prescription-required hearing devices, wearable apps, and gadgets,
as well as sleep strips and mouthpieces for breathing during sleep.
But, while the products will provide greater access, the impact, experts say, will require a culture shift, the details of which are unknown, and, particularly in the case of the watch’s apnea feature, could place a huge burden on the sleep care community and even run the risk of having negative impacts on some patients, they said.
“There’s a need to identify sleep apnea because it is an epidemic,” said Eric Gantwerker, MD, MSc, MS, a pediatric otolaryngologist at Cohen Children’s Hospital at Northwell Health in New Hyde Park, N.Y., who has also treated adults and closely follows tech advances in otolaryngology. “And so, I think everybody’s just trying to get access to that market and trying to basically make a dent in identifying sleep apnea.”
But, he said, “You’re going to have a lot of the worried well showing up, and basically what that does is it floods the physicians, or it floods the clinics with lots and lots of worried well. And that’s always going to be my concern about any consumer-level screening product.”
Apple reports that its hearing aid feature was evaluated in a clinical study with 118 subjects with perceived mild to moderate hearing loss at several U.S. sites, and that those who used the self-fitting strategy had a similar benefit to those who had the same device fitted by a professional. Tests that measured amplification levels in the ear canal and for speech understanding in noise showed comparable performance (U.S. Food and Drug Administration. https://www.fda.gov/news-events/press-announcements/fda-authorizes-first-over-counter-hearing-aid-software).
The results appeared similar to a JAMA Otolaryngology-Head and Neck Surgery randomized clinical effectiveness trial on OTC hearing aids that found that those that were self-fitted using the remote assistance supplied by the manufacturer produced similar outcomes at six weeks to the same devices fitted by an audiologist (JAMA Otolaryngol Head Neck Surg. doi:10.1001/jamaoto.2023.0376).
Sujana Chandrasekhar, MD, partner at ENT and Allergy Associates in New York and Parsippany, N.J., and past president of the American Otological Society and American Academy of Otolaryngology-Head and Neck Surgery, said AirPods hearing aids, which would use Apple’s hearing test as a guide to suit an individual’s hearing, will likely be a big boost to the OTC hearing aid concept, which has been helpful but hasn’t brought as much transformation as had been hoped.
“By providing a modicum of a hearing threshold test, and by looking like something people want to wear, the new AirPods technology may be better adopted,” she said. “Hearing aids”—whether OTC or prescribed—“that are not correct for one’s hearing loss [are] the easiest way to fall into a non-use pattern.”
She views OTC hearing aids “as I do reading glasses, which correct for mild vision loss, and then prepare the individuals for more interactive ophthalmology and optometry care,” she said. Before OTC devices, only about a third of those over 70 who could benefit from hearing aids actually had them, and fewer than one in five of those 20 to 69 years old, she said (National Institute on Deafness and Other Communication Disorders. https://www.nidcd.nih.gov/health/statistics/quick-statistics-hearing). And the OTC hearing aids have been of variable quality, often with price tags that discourage or even preclude use, experts said. Therefore, Dr. Chandrasekhar said, the huge market of potential users “has not really been budged yet” by OTC hearing aids.
The stigma issue could start to abate with the AirPods, she said.
“It used to be a stigma to wear glasses; then the OTC readers came out and first they had very thin frames, trying to be invisible,” she said. “I wear readers now, and they are bright and colorful and very visible on my face—ditto for my husband’s and son’s prescription eyeglasses. In that same vein, I think pretty, effective, not-too-expensive OTC hearing aids will break the stigma of hearing loss and encourage people to enjoy hearing to the fullest.”
Dr. Golub said the hope for OTC hearing aids was that they would be priced below $1,000, and ideally below $500, but most of the better ones are not.
“Kind of interestingly,” he said, although Apple products are usually priced at a premium, the price of the Apple hearing aid “is the price of an AirPods Pro 2, which is $250, which is very cheap for an over-the-counter hearing aid.”
“If it is decent,” he said, “it’s exciting for multiple reasons,” not the least of which is that there are about 100 million AirPods users worldwide, although that isn’t specifically the AirPods Pro 2 users.
OTC hearing aids have helped increase awareness of hearing loss and destigmatized hearing aids to an extent, but not enough, he said.
“Definitely the uptake has not been as good as we would hope, but that’s not surprising because it’s relatively early on; it’s only been a couple of years,” he said.
The entrance of AirPods into the market flips the image issue on its head, he said.
“AirPods are white, the most obvious color, on purpose—they’re designed to stand out; they’re not designed to blend in,” he said. “And so I’m very excited to see where this all goes, because Apple has taken a consumer electronic product that is designed to be flashy and obvious and added a hearing aid feature to it. Hearing aid features are typically supposed to be opposite—invisible.”
Dr. Gantwerker said that some people, thus far, haven’t wanted to use an OTC hearing aid, no matter the price.
You’re going to have a lot of the worried well showing up, and basically what that does is it floods the physicians, or it floods the clinical arena with lots and lots of worried well. And that’s always going to be my concern about any consumer-level product. —Eric Gantwerker, MD, MSc, MS
“Even if given the opportunity of saying, ‘These hearing aids are free, just take these, please use them,’ a proportion of them will not,” he said, “mainly due to the stigma around hearing loss and the unaesthetic appeal of many options on the market.”
He said the use of OTC hearing aids, including the AirPods, should not come at the expense of hearing evaluations that could detect a deeper medical issue—such as sensorineural hearing loss due to a tumor or neurological disease—or a simple matter that doesn’t require any hearing aid at all. Also, he said, amplification alone does not necessarily equate to better hearing, as some people with hearing loss have very poor speech discrimination, so just being louder doesn’t mean being clearer.
“We have many people come in, and they’re complaining about hearing loss, and they have a wax impaction,” he said. “And they’ve bought over-the-counter hearing aids. And like, no, you just need your wax cleaned out. If you have some element of hearing loss that you want to treat with an over-the-counter solution, I’m okay with that. Make sure you don’t have, A, something really easy and simple to fix and, B, you don’t have something bad.”
If AirPods are going to have the deep impact that is hoped for, there will need to be a culture change in how earphones are perceived socially by others.
After Dr. Chandrasekhar’s initial excitement over Apple’s announcement, she said, she realized that “when I see people with AirPods in their ears, I assume they are not hearing or listening to me, but to whatever they are streaming. My reaction will have to change!”
Dr. Golub said it will require a shift in “what it means to the outside world when you’re wearing something in your ear.” Now, walking around with white AirPods is a telltale sign of seclusion, he said.
“How do people know whether you are in the talk-to-me hearing aid mode, or the don’t-talk-to-me-I’m-listening-to-music mode? You’ll have no idea. It’ll be very confusing.”
Dr. Gantwerker said the AirPods as hearing aids would be most valuable in settings in which it is most odd socially to be seen with them in your ears.
“Most of the time people have problems hearing in noise; it’s in busy environments,” he said. “And so what is going to be said if you’re sitting down in a busy environment and you have two AirPods in? That’s a little odd. It’s like being inside wearing sunglasses.”
Apple’s foray into the sleep apnea sphere brings another set of challenges—clinics and sleep centers potentially overrun by those who may get alerts but who don’t have serious apnea issues, Dr. Gantwerker said.
Because of the extensive resource and time burden of a sleep study—if users pursue one when alerted by their watch—the accuracy of Apple’s sleep apnea feature is crucial.
In a publication on its testing and validation, Apple reports that its accelerometer-based method was designed to detect hypopnea using the stricter 4% oxygen desaturation definition. It checks its breathing disturbances data every 30 days, and if there have been 10 or more sessions with breathing disturbances in those 30 days, users are alerted that they may have sleep apnea; otherwise, it’s silent. The design and testing of the feature was developed with data from more than 2,000 participants and more than 10,000 sleep nights, Apple says ( https://www.apple.com/health/pdf/sleepapnea/Sleep_Apnea_Notifications_on_Apple_Watch_September_2024.pdf).
The test was designed to err on the side of accuracy when a user receives an alert, at the expense of missing some apnea cases, the company says.
“The operating point on the ROC curve was intentionally chosen to favor specificity, understanding that operating point positions with high specificity have lower sensitivity. This choice supported the goal of minimizing the false positive risk, which is particularly important for a feature designed to repeatedly check for signs of possible sleep apnea over time (and in consideration of the cumulative false positive rate) while simultaneously maintaining an impactful true positive rate.”
For moderate to severe sleep apnea, Apple reported that the sensitivity rate was 66.6% and the specificity rate was 95.9%.
Dr. Gantwerker said that is “actually much better than I would think.”
But with only 2,500 sleep centers in the U.S., wait times of months for a sleep study in some parts of the country, and millions of people who wear an Apple Watch, the demand might be a major strain, he said. Cardiology colleagues have said they’ve seen an uptick in patients worried after ECG readings from their Apple Watch, he said, and a similar phenomenon could be seen with the apnea feature.
“We’re just going to have to figure out who among these folks who are screened positive are getting the actual sleep studies, because we don’t have the infrastructure to support it,” he said. If someone wants a continuous positive airway pressure (CPAP) machine, they need a sleep study for it to be covered by insurance, he said.
Robson Capasso, MD, a sleep surgery specialist and professor of otolaryngology–head and neck surgery at Stanford University in Redwood City, Calif., said those who are likely to benefit most from the sleep apnea feature of the Apple Watch are unlikely to have one.
“Who is the user of the Apple Watch?” he asked. “Usually, it’s an urban, younger, healthy person who has a lower likelihood of having moderate to severe sleep apnea, [rather] than an older, more obese, rural user.”
He worried that users might sometimes get an alert that is not indicative of a real medical issue.
“Sleep tests are very commonly positive, especially in adult males—and a broader clinical context is very important to recommend any therapies, as well as adequate follow-up.”
The Apple Watch’s ability to provide sleep metrics, he said, might help provide feedback on whether habit changes have moved sleep routines in the right direction.
Dr. Capasso said that it is important that the Apple Watch update not become yet another source of data that could increase the prevalence of orthosomnia—anxiety over sleep quality generated by sleep scores—which is something that “we are already seeing quite commonly in the clinic.” This phenomenon has been brought about by the explosion of sleep-tracking products—from rings to snoring tracker apps to other wearables without a well-designed consumer feedback interface.
“But I am sure the Apple team, who notoriously excel in design, knows about it,” he said.
“Sleep is counterintuitive,” Dr. Capasso said. “Some users of sleep technologies may go into perfectionist tasks in order to improve sleep scores, and it may actually worsen it as some start catastrophizing and overthinking about their sleep.”
“Sleep became very commercialized,” he said. “It is more Googled than ‘nutrition’ these days and, of course, there is a lot of entrepreneurial mindset around sleep.”
When someone has concerns about sleep, his first inclination is to suggest they adjust the timing and pre- and post-bedtime routines and habits.
“Please stop checking your emails, doing work-related activities, or playing video games just before you go to bed,” he said. “You’re not going to feel refreshed tomorrow.”
Thomas R. Collins is a freelance medical writer based in Florida.