AirPods Pro 2 Just Received FDA Approval for Dual Use as Hearing Aid

Apple AirPods Pro (2nd generation) serial number on right earphone.

Lil Katz / Android Authority

In short

Following FDA approval, Apple’s AirPods Pro 2 will soon be eligible for use as over-the-counter (OTC) hearing aids for adults.
The update will amplify sound for people with mild to moderate hearing loss and create a custom sound profile through the Apple Health app.
It’s a major step toward integrating health features into consumer technology, and will likely inspire similar innovations from competitors like Samsung.

Apple is ready to bring hearing aid features to AirPods Pro 2 after receiving formal approval for the software from the Food and Drug Administration (FDA). The public health and safety body has deemed the AirPods Pro the first “over-the-counter (OTC) hearing aid software.”

When the update comes to the AirPods Pro 2, as Apple announced during its iPhone 16 launch event, the headphones will amplify sounds for those with perceived mild to moderate hearing impairments. To be clear, the FDA has only approved the AirPods Pro 2 as hearing aids for adults 18 years or older. So minors and children with hearing problems may need a different solution.

Apple’s move to develop a hearing aid feature for AirPods is a significant milestone for the truly wireless ecosystem, and we’ll likely see more brands implementing healthcare solutions in earbuds in the future. Samsung is also offering an Ambient Sound feature on the Galaxy Buds Pro, which lets users control the tonal range of each earbud. It’s not the same as what Apple is doing in a planned software update for the AirPods Pro 2, but it could be a precursor to a full-fledged hearing aid mode from Samsung.

Currently, AirPods Pro 2 are the only wireless earbuds approved by the FDA as OTC hearing aids, a regulation that allows consumers to purchase hearing aids directly from stores or online retailers without the need for a medical exam, prescription, or visit to an audiologist.

Apple hasn’t yet started rolling out the hearing aid software to the AirPods Pro, but an automatic update shouldn’t be far off now that the FDA has given it the go-ahead. Once the update arrives, users will be able to take a clinically validated hearing test through the Apple Health app to see if they have hearing loss. If the test detects hearing loss, the AirPods will create a custom sound profile to optimize the user’s listening experience.