FDA greenlights AirPods Pro 2's hearing aid features

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

10 Comments

2morrow 23 comments · 4 Years

About 2 months ago

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?

mike1 3431 comments · 10 Years

2morrow said:

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?

Likely will need separate approval for each model. If the underlying software is the same, then separate approval would come much more quickly from the FDA.
Would not affect the timeline for two reasons. One, they can always add as an update for each model just like they are doing here or two, they build the expected timeline for FDA approval into the launch plans from the start.

mac voyer 1199 comments · 22 Years

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.

charlesn 1151 comments · 11 Years

mike1 said:

2morrow said:

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?

Likely will need separate approval for each model. If the underlying software is the same, then separate approval would come much more quickly from the FDA.
Would not affect the timeline for two reasons. One, they can always add as an update for each model just like they are doing here or two, they build the expected timeline for FDA approval into the launch plans from the start.

Since what they're approving are the capabilities of the software update and NOT the hardware, I don't see why new approval would be needed for new hardware if the "software hearing aid" capability remains unchanged. I would guess that this update could even be rolled out to regular Airpods, but Apple is choosing to keep it an Airpods Pro exclusive. I say this because based on the functionality as described, there's nothing I've read that seems beyond the capability of regular AirPods to handle, especially AirPods 4.

MacPro 19836 comments · 18 Years

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.