Malcolm Owen
The U.S. Food and Drug Administration has cleared the AirPods Pro 2 to get the announced clinical-grade hearing aid features in a future software update.
During Apple's "Glowtime" special event, a software update for the AirPods Pro 2 was revealed, one which could help millions deal with hearing loss. At the time, the FDA was in the process of approving the software, but by Thursday, it had given it the green light.
The FDA's confirmation says the update is its first authorization of an "over-the-counter hearing aid software device" in the form of the AirPods Pro update. The feature is intended to amplify sounds for users aged 18 years or older with "perceived mild to moderate hearing impairment," the FDA adds.
"Hearing loss is a significant public health issue impacting millions of Americans," explains Michelle Tarver, M.D., Ph.D., acting director of the FDA's Center for Devices and Radiological Health. "Today's marketing authorization of an over-the-counter hearing aid software on a widely used consumer audio product is another step that advances the availability, accessibility and acceptability of hearing support for adults with perceived mild to moderate hearing loss"
It was evaluated in a clinical study with 118 people with mild to moderate hearing loss. The results determined that the AirPods Pro with the update had a similar perceived benefit when self-installed by users as those who had it installed by professionals.
There was also a comparable performance for tests measuring amplification levels in the ear canal. Benefits were also seen when measuring how they faired listening to speech within noise.
The results mean Apple can roll out the update to the AirPods Pro 2 in the near future to its users. Timetable is as yet unclear, beyond before the end of 2024
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10 Comments
How does this work when AirPods Pro 3 or whatever future models eventually comes out? Will they need to get approval for each version or does this apply to the entire series of AirPod Pros going forward? Could that slow down the timeline of each release?
How long before AirPods are hit with gatekeeper status? 😀 I'm sure there is some competitor in the EU pushing to force Apple to allow third-party AirPods made and branded by competitors. Otherwise, Apple has too much of an advantage.
Got my new AirPods Pro2s yesterday. They are far comfier than my previous versions, and they stay in extremely well. The audio quality is amazing. I am hard of hearing and I can't wait for iOS 18 and the new hearing features.