The encyclopedia · Product & Design · Product decision · 2024–2025
Apple turned AirPods Pro 2 into an FDA-cleared hearing aid with a software update
A free update added a Hearing Test and a clinical-grade over-the-counter Hearing Aid feature, making hearing assistance an app on earbuds people already own.
Apple
the move
The WHO estimates about 1.5 billion people live with hearing loss, and Apple's Hearing Study found 75% of people diagnosed with it go untreated — cost and stigma keep them away from dedicated hearing aids.
On September 9, 2024, Apple announced an all-in-one hearing health experience for AirPods Pro 2: Hearing Protection, a scientifically validated Hearing Test, and an over-the-counter Hearing Aid feature for mild to moderate loss, delivered in a free fall software update.
Three days later the FDA authorized the first over-the-counter hearing aid software, clearing the Hearing Aid Feature as a software-only medical app backed by a 118-subject study. The feature shipped in more than 100 countries, and the work was shortlisted in Product Innovation at Cannes Lions 2025.
why it works
- It uses earbuds people already own, removing the separate-device hurdle and much of the cost.
- Test and aid are bundled, so users discover their hearing loss in minutes at home.
- FDA clearance gave a consumer feature the authority of a medical device.
- Personalized profiles carry over to music, calls and movies, so the aid isn't a separate burden.
what transfers
When distribution already exists, the moat is regulatory: a software feature turned commodity earbuds into a medical device category.
what came after
After FDA marketing authorization on September 12, 2024, the Hearing Aid Feature rolled out with iOS 18 in more than 100 countries. Media and analysts framed it as a milestone for accessible hearing care, and Cannes Lions 2025 shortlisted it in Product Innovation.
references
- Apple introduces AirPods 4 and the world's first all-in-one hearing health experience with AirPods Pro 2
- FDA Authorizes First Over-the-Counter Hearing Aid Software
- Cannes Lions 2025: Titanium and Innovation Lions Shortlists Announced
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