FDA Clears Apple’s AirPods Pro to Act as Your Hearing Aids

Apple was a little too excited to showcase its AirPods Pro earbuds working as a pair of hearing aids at its big Glowtime hardware blowout this week. The missing piece of the puzzle was regulatory approval to treat the buds as OTC medical tech. We didn’t have to wait long, as on Thursday the U.S. Food and Drug Administration (FDA) gave the tech giant the thumbs up, saying it authorized AirPods Pro to work as a “hearing aid software device.”

It’s the first OTC hearing aid solution implemented as a software feature for an existing product. There are a few new hearing capabilities coming to iPhones and the Apple Health App, but the big headlining capability is an assistance mode for earbud wearers. Users need to take a series of tests with an iPhone to create their listening profile, and the AirPods 2 should now boost sounds like speech or music in real-time. You can also set it up with an audiogram crafted by a doctor.

The FDA said it cleared Apple’s hearing aid feature after conducting a clinical study with 118 subjects who described mild to moderate hearing loss. In its press release, the agency said, “The results demonstrated that subjects who used the HAF self-fitting strategy achieved similar perceived benefit as subjects who received professional fitting of the same device.” The study noted it did not find any adverse effects for users who tried out the new AirPods software.

The hearing aid features will arrive in an update to the AirPods Pro 2 sometime this fall, according to Apple. It’s meant to help those with mild to moderate hearing impairments, but it won’t be a boon to those with severe auditory issues. That should be expected considering the limitations of the hardware. Back in 2022, an executive order from President Joe Biden and the FDA paved the way for OTC hearing aids without needing a prescription. The entire point was to offer more avenues for the approximately 30 million U.S. citizens with hearing issues without needing to spend $2,000 or even as much as $10,000 for prescription medical devices.

We’ve been hearing about Apple’s plans to turn its AirPods into OTC hearing aids for years. It’s clear Apple has been building up to this for a while with some of its other accessibility features. Features like Live Listen allowed an iPhone or iPad access to a sound-boosting microphone. Previous studies showed the AirPods could work as a cheaper kind of sound amplification device. 

Apple is adding a few more software features for hearing, including a simplified hearing test available through the Apple Health app. As cool as this is, there are issues with using a pair of AirPods as a replacement for full-blown hearing aids. A regular pair of in-ear auditory aids are meant to stay in your ear continuously for hours. AirPods—though more comfortable than most buds—are still just a consumer-end pair of earbuds.

The feature won’t come to the new $130 base or $180 ANC AirPods 4. Even $250 is a fraction of other modern OTC hearing aids like those device makers like Jabra or Audicus. The medical device industry is already a tangled snake pit of obscene prices as evidenced by hearing aids over the past decades. Apple’s not exactly known for making the most budget-friendly products. When a tech monolith like Apple comes along and somehow manages to make medical tech look like a price-gouging nightmare, you know the U.S. health apparatus is intrinsically screwed up.