The US Food and Drug Administration has approved Apple’s over-the-counter hearing aid feature, designed for people with mild to moderate hearing loss, that turns the second-generation AirPods Pro into an over-the-counter hearing aid. This follows the FDA’s 2022 decision to allow adults with less-than-severe hearing impairments to use consumer hearing aids without a professional exam, prescription, or fitting.
The FDA said Apple’s software-based hearing testing feature in AirPods Pro performed as well as people who had the wireless earbuds professionally fitted. “Results showed comparable performance in tests that measured amplification level in the ear canal and speech intelligibility in noise,” the FDA said in a statement. The agency added that it had not observed any “adverse events” from using the devices as over-the-counter hearing aids.
Apple’s hearing aid feature coming in iOS 18 starts with a hearing test on your paired iPhone or iPad. As the image above shows, the test starts by making sure your earbuds are in place, then Active Noise Cancellation (ANC) kicks in and asks you to tap the screen when you hear sound in each ear.
Once you’re done, your results are stored in the iOS Health app, where you can see how they change (or don’t) over time. You can download your results at any time to give to your hearing care professional. (If the test indicates a severe hearing loss, we recommend that you get evaluated by a hearing care professional, as AirPods are only approved for people with mild to moderate hearing loss.)
Engadget’s Billy Steele got an early preview of the feature after Apple’s big iPhone 16 event earlier this week. “It appears to be quick and easy, just as Apple described it,” our audio expert wrote. Though the demo was a simulation, it covered each step of the process and only took about five minutes in total.
Apple developed the feature using 150,000 real-world hearing tests and millions of simulations, and its FDA application was reviewed under the FDA’s De Novo premarket review process, which gives a grace period to new devices that don’t pose serious risks.
Apple’s hearing aid and hearing testing features won’t be available before iOS 18 is released to the public on September 16. You’ll need AirPods Pro (2nd generation) to use this feature.
