You may be carrying around in your pocket or purse a small device that could soon become an inexpensive hearing aid with the help of new software cleared by the Food and Drug Administration. Millions of people already own them.
It’s Apple’s AirPods Pro 2, those white plastic knobs that stick out of the ears of many people in malls, workplaces, buses and sidewalks. This user may not be among the 30 million American adults who report some degree of hearing loss. Maybe you’re listening to music, a podcast, or just talking on your phone.
However, in the coming weeks, consumers will be able to use these AirPods Pro 2 earbuds to enhance their hearing. Last month, Apple’s software Hearing Aid and Hearing Test received the green light from the FDA. This is a first for the regulator.
Users will be able to test their hearing using an iPhone or iPad that is compatible with upcoming software releases. For people with mild to moderate hearing loss, AirPods Pro 2 adjusts the sound of your environment and devices.
Users will be able to customize the volume, tone, and balance of their AirPods. All of this should help you hear better, at least for about 5-6 hours of battery life on your device.
Apple plans to release free software later this fall for iPhones running iOS 18 or later and iPads running iPadOS 18 or later, a spokesperson said. Apple sells a set of AirPods Pro 2 for $249, but you can find them for less at major retailers and online retailers.
That’s what reformers had in mind when Congress directed the FDA in 2017 to develop regulations for high-quality over-the-counter hearing aids.
The idea was to change the existing gatekeeping model, where people can only obtain prescription aids through licensed professionals for thousands of dollars a pair. Instead, over-the-counter hearing aids that are beneficial to most people with hearing loss are available at CVS or Walmart for a few hundred dollars and do not require an audiologist or prescription.
The FDA took three years to develop these regulations. It took 5. Finally, two years ago, the world of hearing care prepared for a change, but that change has not yet fully occurred.
“There is no evidence that over-the-counter hearing aids have dramatically changed the hearing market,” said Nicholas Reed, an audiologist and epidemiologist at New York University Langone Health.
“I think in two years’ time there will be a lot more people owning hearing aids by now,” he added.
However, the latest National Health and Aging Trends study found that although about two-thirds of Americans over 70 have some degree of hearing loss, less than 30% have hearing aids, which is The results have been shown to be fairly consistent. Ownership rates are even lower among blacks, Hispanics, and low-income seniors.
“Hearing loss develops so gradually that many people don’t even know they have hearing loss,” says Andy, audiologist and scientific consultant for HearAdvisor, which tests and evaluates hearing aids.・Sabin says.
In fact, regular surveys by the Hearing Industry Association show that people who identify as having hearing loss take years to purchase hearing aids.
However, perhaps thanks to recent education campaigns, delays in receiving treatment have fallen from six years in the 2019 study to four years in 2022. And now, with the entry of high-profile consumer company Apple into the over-the-counter market, that delay could be hastened. It changes.
“The moment you hear better and notice the birds singing outside your window,” Dr. Sabin said, “the lights turn on. And now that moment is much closer to you.” Like others in the field, he expects more manufacturers and software developers to follow Apple’s lead.
“The way the FDA works, once the first company gets through the gate, it’s very easy to become the second company,” Dr. Sabin said.
“We expect many other companies to also introduce hearing aid functionality in their earphones,” he added. (Dr. Sabin is a Bose engineer by trade, and his technology is already used in commercial hearing aid brands.)
The FDA said it cannot disclose details of pending product applications.
Concerns about hearing among older Americans reflect a wave of research showing how important hearing is to physical and cognitive health. In 2020, the Lancet Commission identified untreated hearing loss as the biggest potentially modifiable risk factor for dementia.
Researchers reported last year that hearing aid use slowed the rate of cognitive decline by 48 percent over three years among study participants who were at higher risk because they were older and less affluent. Untreated hearing loss also increases the risk of social isolation, depression, and falls.
So why aren’t more older Americans using over-the-counter hearing aids?
Price remains an important factor. The FDA has approved 10 brands of higher-quality hearing aids (labeled “self-fitting”) in the past two years, which typically cost between $800 and $1,000. Traditional Medicare does not cover hearing aids, and while some Medicare Advantage plans offer hearing benefits, beneficiaries still end up paying the majority of the cost themselves.
Bridget Dobien, executive director of the Hearing Aid Industry Association, the main lobbying group for hearing aid manufacturers, said that in addition to high prices, “consumers are still confused about their options and who to see and when.” We know.”
“If you type in ‘OTC hearing aids’ on Amazon, you’ll see hundreds of products, some for $1,000, some for $100,” Dr. Reed said. “How should consumers navigate this market?”
Devices that are not identified as “self-regulating” are registered with the FDA, but manufacturers are not required to provide evidence of actual effectiveness. Anything under $250 “is probably junk,” Dr. Sabin says.
Although consumers cannot yet try new software, Dr. Reed added that Apple is a “well-known and trusted company” with global brand recognition. If that happens, even more people with mild to moderate hearing loss — the demographic Apple’s software targets — could become de facto hearing aid owners.
Another benefit: Earphone use is age-independent, which may reduce the stigma against traditional hearing aids. No one knows whether the earphone wearer is listening to Arcade Fire or trying to understand a conversation.
“people want “Wearing AirPods will make my kids want them,” Dr. Reed said. “That change in attitude is a big problem.”
It may also encourage earlier use, he said, because “sometimes you can start using it in your 40s or 50s, before you really need it in your 60s or 70s,” when hearing loss accelerates. added.
AirPods as hearing aids also have disadvantages. They are not as powerful or sophisticated as prescription aids, nor are they intended for people with profound hearing loss. It doesn’t work even if you wear it all day. “You have to use them temporarily,” Dr. Sabin said.
Another potential downside to using AirPods Pro 2 is that it may take a few weeks to get used to the hearing aids. Apple requires returns within 14 days, and there’s a fee to replace lost AirPods, which isn’t an uncommon problem. Other manufacturers of self-fitting OTC devices have varying return policies, but some offer 45-day returns and warranties cover replacement of lost or damaged devices (usually at an additional charge). may occur.
Hearing aid features also require a late model iPhone, which costs between $800 and $1,200, or an iPad, which costs between $349 and $999.
People with mild to moderate hearing loss who don’t already own an Apple product can purchase prescription hearing aids at Costco instead. Costco’s hearing aids start at $1,500 and have better warranties and return policies.
Still, advocates who have been pushing for more accessible and affordable hearing aids for years sound genuinely excited.
“This is what we wanted: innovation,” said Barbara Kelly, executive director of the Hearing Loss Association of America. “Apple’s attention pushes the idea of hearing health into the mainstream.”
