FDA Grants Approval to AirPods Pro 2 for Use as Hearing Aids

Brian Heater, reporting for TechCrunch:

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.

In briefings on Monday, Apple employees expressed what I can only describe as confidence that FDA approval for this would be imminent, but like sports fans, it was almost as though they didn’t want to jinx it. Asked if FDA approval might come before the iOS 18.0 and MacOS 15.0 updates scheduled for this coming Monday, they wouldn’t really answer, but had looks on their faces that said that’s what we’re hoping.

What a great feature this seems to be.

★ Thursday, 12 September 2024