Apple AirPods Pro granted FDA approval to serve as hearing aids

The iPhone 16 took center stage at Apple’s “It’s Glowtime” event, but the most interesting tidbit came from a different line entirely. Indeed, among a sea of new hardware came an intriguing software update to one already on the market: the AirPods Pro 2.

Apple announced that its most premium earbuds would double as an over-the-counter hearing aid, courtesy of a software update, pending approval from the U.S. Food and Drug Administration.

The FDA on Thursday announced that it has granted what it calls “the first over-the-counter (OTC) hearing aid software device, Hearing Aid Feature.” Specifically, it has approved the software update that enables that functionality.

“Hearing loss is a significant public health issue impacting millions of Americans,” the FDA’s Michelle Tarver notes in a statement. “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.”

The news was made possible in part by the FDA’s October 2022 move to allow for the sale of hearing aids without a prescription. That move has given rise to a new industry of more easily accessible hearing devices.

Earlier this week, TechCrunch went hands-on with a demo version of Apple’s new hearing test. The feature will be accessible via settings in iOS 18 when a pair of AirPods 2 are connected. Users will have to receive a result of mild to moderate hearing loss in order to take advantage of the new feature. Alternately, they can also upload test results from a doctor.

The hearing aid functions by adjusting different frequency levels, in order to amplify key sounds such as the human voice.