FDA approves some Apple AirPods to be used as hearing aids

Two years after federal health officials approved the sale of
hearing aids, some Apple AirPods owners may soon be able to access the medical device in the comfort of their home with the click of a software update.
The Food and Drug Administration on Thursday
Apple’s new “Hearing Aid Feature” which will amplify sounds for people with perceived mild to moderate hearing impairment. The Apple feature, coming this fall via a free software update, will only work with AirPods Pro 2 ear buds and iOS 18-compatible iPhones or iPads. It is intended for adults 18 or older.
More than 30 million American adults have some degree of hearing loss. But only 1 in 6 Americans with hearing impairments between the ages of 20 and 69 actually use hearing aids due to high cost, lack of accessibility, poor customer satisfaction and stigma, according to the
.
Research shows that if left untreated, hearing loss can increase the risk of
, depression, cognitive decline and frailty. Meanwhile, other studies suggest that using hearing aids may reduce the frequency or severity of those health problems in older adults as well as possibly
.
With the new feature, Apple AirPods owners will be able to check their hearing at home through a five-minute test and adjust their sound settings based on their hearing.
“Your AirPods Pro are transformed into a personalized hearing aid, boosting the specific sounds you need in real time, like parts of speech or elements within your environment,” said Sumbul Ahmad Desai, Apple’s vice president of health, in an announcement video.
For years, advocates for people with hearing loss have been calling for more affordable and accessible medical devices. It paved the way for the FDA in 2022 to approve hearing aids to be sold without a prescription. But according to the National Council on Aging, hearing aids can still be costly — pricing from $99 to $7,000
. (AirPods Pro 2 are priced at $249.)
Meredith Resnick, a spokesperson for the Hearing Loss Association of America, said she hopes Apple’s new hearing aid feature will help spread awareness and reduce stigma around hearing loss. But she added that most over-the-counter (OTC) devices — including Apple’s — mainly serve people with mild to moderate hearing loss.
“OTC hearing aids won’t be for everyone, but we hope they help some adults with mild-to-moderate hearing loss take a first step towards treatment sooner. An OTC hearing aid, for example, may help someone who needs some situational hearing help, but isn’t at the level of wearing a device all day,” she said.
The FDA approval came after a clinical study with 118 subjects with perceived mild to moderate hearing loss. The results showed that the subjects who used Apple’s hearing aid feature “achieved similar perceived benefit as subjects who received professional fitting of the same device.” The FDA added that “no adverse events related to the device were observed in this study.”
“Today’s marketing authorization of an over-the-counter hearing aid software on a widely used consumer audio product is another step that advances the availability, accessibility and acceptability of hearing support for adults with perceived mild to moderate hearing loss,” Dr. Michelle Tarver, acting director of the FDA’s Center for Devices and Radiological Health, said in a statement.