Apple’s AirPods Pro can now function as an FDA-authorized over-the-counter hearing aid for adults with perceived mild to moderate hearing loss. The Hearing Aid Feature was cleared on September 12, 2024, covering AirPods Pro 2 and AirPods Pro 3, with at-home te
A lot of people hear “you should get your hearing checked” and feel their stomach drop—not because they don’t care, but because the process can feel expensive, complicated, and oddly intimidating. Now Apple’s AirPods Pro are aiming right at that moment.
On September 12. 2024. the FDA authorized Apple’s Hearing Aid Feature. clearing it through the agency’s de novo pathway for novel. low to moderate risk devices. The pitch is simple: the earbuds people already wear can screen for and treat mild to moderate hearing loss—using software cleared for an over-the-counter hearing aid.
The authorization is anchored to a clinical trial registered at ClinicalTrials.gov as Apple’s Smartphone Enabled Hearing Study. In that 118 person study, self fitted AirPods matched professionally fitted results, with no device related adverse events. Performance also lined up in speech in noise and amplification accuracy. A separate peer reviewed study in the Yonsei Medical Journal tested the earbuds’ headphone accommodation feature on 35 adults with mild to moderate hearing loss. finding it performed on par with a validated personal sound amplification product while improving word recognition and speech understanding in noise.
The real question now isn’t whether the idea is surprising—it’s what it changes for people who have been putting off help.
AirPods Pro Hearing Aid Feature: which models are covered?
The FDA authorization applies to AirPods Pro 2 and the newer AirPods Pro 3. Apple’s hearing health page describes the setup as the world’s first end to end hearing health experience built into consumer earbuds.
Older AirPods models are not covered. That includes the original AirPods Pro, which cannot run the Hearing Test or Hearing Aid feature. To complete the at home test and store the resulting hearing profile, users also need a compatible iPhone.
How the at-home hearing test works
Anyone with a compatible AirPods Pro model and iPhone can run the built in hearing test in about five minutes. The test plays tones at varying volumes and frequencies while the earbuds seal the ear canal, then generates a personalized result.
If the test detects mild to moderate hearing loss, the Hearing Aid feature can use that profile to amplify conversations and environmental sounds in real time. Results are saved in the iPhone’s Health app, where they can be shared with an audiologist or physician.
How much does it cost compared to prescription hearing aids?
The hardware is priced aggressively compared with traditional devices. AirPods Pro 2 and AirPods Pro 3 both retail for $249.
Prescription hearing aids commonly run well into the thousands per ear, and a single ear prescription fitting can cost several times what a pair of AirPods does. That gap matters because two barriers come up again and again: cost and stigma.
The numbers attached to that reality are stark. About 75 percent of adults with age related hearing loss go untreated. and the average person waits roughly nine years between first noticing hearing loss and doing something about it. Study authors have also flagged hearing loss as one of the most easily modifiable dementia risk factors. positioning early amplification as a proactive health decision rather than something purely cosmetic.
A test you can run—without promising what it can’t do
Even with the FDA authorization, there are hard limits. The clearance covers self fitted use for adults with perceived mild to moderate hearing loss, not severe or profound loss and not pediatric cases.
The authorization is also specific to AirPods Pro 2 and Pro 3. Users of older models won’t get the same clinical grade performance, even if audio settings are adjusted manually.
What the feature does aim to do is close a treatment gap for adults with hearing loss who currently go without any device. It offers a way to confirm a suspicion. try amplification. and share results with a clinician before committing to the cost and appointments that can come with a traditional hearing aid path.
The promise, then, isn’t replacement. It’s a foot in the door for people who have been waiting.
AirPods Pro Apple hearing aid feature FDA authorized hearing aid Hearing Test over the counter hearing aid AirPods Pro 2 AirPods Pro 3 smartphone enabled hearing study ClinicalTrials.gov