FDA Announces Clearance of ‘Software Hearing Aid Device’ Following AirPods Pro

The Food and Drug Administration (FDA) made a major announcement Thursday, ruling that it has cleared Apple’s upcoming hearing aid feature for the AirPods Pro 2. The federal agency writes that it has blessed what it calls “the first over-the-counter (OTC) hearing aid software device.” News of the software clearance comes just days after Apple announced the feature at its annual September special event.

It’s particularly important to note that the FDA notes in its press release that Apple’s hearing aid feature is intended only to “amplify sounds for people 18 years of age or older with mild to moderate perceived hearing loss.”

“Hearing loss is a major public health problem that affects millions of Americans,” Michelle Tarver, acting director of the FDA’s Center for Devices and Radiological Health, said in the FDA’s statement. “Marketing approval of 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 aids for adults with mild to moderate perceived hearing loss.”

I’ll have more to say about AirPods and hearing aids in another post soon. For now, it’s worth repeating what I wrote yesterday about the importance of Apple’s hearing aid feature. Not only does the company provide a clinically reliable hearing test with easy-to-digest results, but AirPods, already firmly entrenched in the cultural zeitgeist as a pair of headphones, of the day—will soon be transformed into real hearing aids will single-handedly change the stigma of wearing hearing aids. As I wrote yesterday, traditional hearing aids have always been boring beige boxes that can help you hear better but are not very aesthetically pleasing and, in Alton Brown’s jargon, are an indispensable tool. They are decidedly not cool. AirPods, on the other hand, are very cool. They are primarily passive listening devices for music, podcasts, audiobooks, and more. They have active noise cancellation and modes for transparency, conversation, and more. accessible with their tight integration with assistive technologies like the VoiceOver screen reader. The bottom line is clear: For a hearing-impaired person who is deeply embedded in the Apple ecosystem, there will soon be no better headphones (or hearing aids) on the market than the AirPods Pro. Period.

Of course, there are caveats. For one, the FDA is explicit in its message today that the AirPods’ hearing aid feature is designed for people with mild to moderate hearing lossFor those with more severe hearing loss, a prescription hearing aid will be the best device. Second, it remains to be seen (or rather, heard) how effective Apple’s software will be in practice. As significant as this week’s news is, there are bound to be issues with Apple’s implementation, especially considering that this is the company’s first attempt at it. This isn’t a criticism of Apple’s insight or ambition; it’s simply an acknowledgement that nothing is ever perfect. Additionally, while it’s true that AirPods are unique in their performance and versatility, there are over-the-counter hearing aids available—one example being Okra, led by former Apple engineer Ben Sun—that can do other computational things like play music in a form factor that mimics the AirPods’ design. For its part, Okra has been mentioned in this column several times, most recently last November when I spoke with Sun about the company’s second-generation Okra One device.

Apple and the FDA’s announcements have resulted in mainstream tech media increasingly focusing on accessibility, and by extension, the disability community. From TechCrunch to The Verge and elsewhere, outlets have picked up on the hearing aid story. At its core, the introduction of AirPods into hearing aids is about accessibility. Hearing aids help people with less-than-optimal hearing abilities hear better. Disability coverage in journalism, in tech and elsewhere, still lags far behind other facets of social justice like race and sexuality.

Apple using AirPods as a Trojan horse to improve people’s hearing health is a clever idea given the focus on health monitoring with the Apple Watch. This is a continuation of that trend by expanding the aperture to a new device. From a journalistic perspective, Apple is Apple—everything they do makes headlines in one way or another. In the context of AirPods and hearing aids, it’s encouraging to see such enthusiastic media coverage of this development in the last few days. This is no small thing given that, again, serious coverage of accessibility in tech usually leaves out a lot be desirable in width and particularly in terms of depth.