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Apple’s AirPods Pro 2 just got FDA approval to double-up as hearing aids

With the FDA's stamp of approval, Apple is all set to help people with mild to moderate hearing loss.
By

Published onSeptember 13, 2024

The Apple AirPods Pro (2nd generation) serial number on the right earbud.
Lil Katz / Android Authority
TL;DR
  • Apple’s AirPods Pro 2 will soon function as over-the-counter (OTC) hearing aids for adults, following FDA approval.
  • The update will amplify sound for those with mild to moderate hearing loss and create a custom sound profile through the Apple Health app.
  • This marks a major step in integrating health features into consumer tech, likely inspiring similar innovations from competitors like Samsung.

Apple is all set to introduce hearing aid capabilities to the AirPods Pro 2 after receiving an official nod for the software from the Food and Drug Administration (FDA). The public health and safety body has recognized the Pro AirPods as the first “over-the-counter (OTC) hearing aid software device.”

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

Apple’s move to develop the hearing aid functionality for AirPods marks a significant milestone for the true wireless ecosystem. We’ll likely see more brands inculcate healthcare solutions in earbuds going forward. Samsung also offers an Ambient Sound feature on the Pro Galaxy Buds, which lets users control the tone range of individual earbuds. It’s not the same as what Apple is doing with its planned software update to the AirPods Pro 2, but it could be a precursor to a full-fledged hearing aid mode from Samsung.

AirPods Pro 2 Hearing Aid feature
Apple

Currently, the AirPods Pro 2 are the only wireless earbuds the FDA has certified as OTC hearing aids. They fall under a regulation that allows customers to purchase hearing aids directly from stores or online retailers without the need for a medical exam, prescription, or seeing an audiologist.

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

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