FDA Announces Authorization for ‘Hearing Aid Software’ After AirPods Pro News

The Food and Drug Administration (FDA) made some big news on Thursday, announcing that it has authorized Apple’s upcoming hearing aid functionality for the AirPods Pro 2. The federal agency writes that it has given its blessing to what it described as the “first over-the-counter (OTC) hearing aid software.” News of the software authorization comes just days after Apple announced the feature at its annual special event in September.

Of particular note is that the FDA notes in its press release that Apple’s hearing aid feature is only intended to “amplify sounds for individuals 18 years of age and older with presumed mild to moderate hearing impairments.”

“Hearing loss is a serious public health problem that affects millions of Americans,” said Michelle Tarver, acting director of the FDA’s Center for Devices and Radiological Health, in the FDA announcement. “Today’s approval of over-the-counter hearing aid software in a commonly used consumer audio product is another step that increases the availability, affordability and acceptability of hearing support for adults with perceived mild to moderate hearing loss.”

I’ll have more to say about AirPods and hearing aids in another article soon. For now, it’s worth repeating what I wrote yesterday about the importance of Apple’s hearing aid feature. Not only is the company providing a clinically accurate hearing test with easy-to-understand results, but AirPods — already firmly ingrained in the cultural lore of in-ear headphones — are also Today—soon to be transformed into full-fledged hearing aids that will single-handedly change the stereotype of wearing hearing aids. As I wrote yesterday, traditional hearing aids have historically been boring, beige boxes that can help you hear better — but they don’t look good doing it, and, as Alton Brown says, they’re a one-size-fits-all task. They’re decidedly uncool. In contrast, AirPods are very cool. They’re primarily passive devices for listening to music, podcasts, audiobooks, and more. They have active noise cancellation and modes for clarity, conversation, and more. They’re available with their seamless integration with assistive technologies like the VoiceOver screen reader. The bottom line is clear: For a hearing-impaired person knee-deep in the Apple ecosystem, there will soon be no better earbuds (or hearing aids) on the market to buy than AirPods Pro. Period.

Of course, there are some caveats. First, the FDA makes it clear in its announcements today that the AirPods hearing aid feature was designed for people with mild to moderate hearing loss. For those with more severe hearing loss, a prescription hearing aid is a better 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 will certainly be implementation issues for Apple — especially given that this is the company’s first foray into the work. This is not a criticism of Apple’s acumen or ambition; it’s simply an acknowledgment that nothing is ever perfect. Moreover, while it’s true that AirPods are exceptional in terms of performance and versatility, there are over-the-counter hearing aids available — one example is Okra, led by former Apple engineer Ben Sun — that can do other computer-like things, such as playing music in a format that mimics the AirPods’ design. Okra, for its part, has been discussed in this column on numerous occasions, most recently last November, when I spoke with Sun about the company’s second-generation Okra One model.

A byproduct of Apple and the FDA’s announcements is that accessibility—and, by extension, the disability community—is creeping into mainstream tech media. From TechCrunch to The Verge and beyond, the media is seizing on the hearing aid story. At its core, the AirPods gaining hearing aid functionality is about accessibility. Hearing aids help people with less-than-optimal hearing abilities hear better. Coverage of disability in journalism, in tech and elsewhere, has always lagged far behind other aspects of social reporting, like race and sexuality.

That Apple is using AirPods as a Trojan horse to improve people’s hearing health is adroit, given the emphasis on health monitoring with the Apple Watch. This is a continuation of that trend by widening the aperture on the 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 heartening to see such enthusiastic media coverage of developments over the past few days. This is not trivial, given how, again, candid coverage of accessibility in technology tends to leave A lot desirable in width and especially in relation to depth.