FDA approves AirPods Pro 2 hearing aid features

AppleInsiderAppleInsider
Posted:
in General Discussion

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.

A pair of white wireless earbuds with a charging case on a green abstract pattern background.
AirPods Pro 2



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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Comments

  • Reply 1 of 10
    2morrow2morrow Posts: 23member
    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?
  • Reply 2 of 10
    mike1mike1 Posts: 3,388member
    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.
    muthuk_vanalingamforgot usernameBart Y
  • Reply 3 of 10
    mac voyermac voyer Posts: 1,295member
    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.
    mike112StrangersdanoxBart Y
  • Reply 4 of 10
    charlesncharlesn Posts: 1,038member
    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. 
    Ofer
  • Reply 5 of 10
    MacProMacPro Posts: 19,815member
    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.
    ronnBart Y
  • Reply 6 of 10
    ssfe11ssfe11 Posts: 80member
    Amazing Apple. Saving lives and health helping everyone. Thank you Tim and all who work at Apple!
    Bart Y
  • Reply 7 of 10
    sakamurasakamura Posts: 5member
    My dad already uses his AirPods Pro 1 as makeshift hearing aids after a suggestion from his doctor. It still helps him have a better hearing and better conversations with people when he occasionally wears them.

    My wife is on the limit of moderate loss. She did the same, but so far she still prefers her smaller hearing aids. They tend to be nearly invisible and will stay locked in no matter the movements, where it's possible to lose the very visible AirPods Pro with a good head shake. Due to size and sealed tips, AirPods Pro also tend to keep moisture trapped, and that can cause issues if worn constantly. Finally, the battery is a few days, vs a few hours, and you need to have your phone nearby.

    On the other side of the coin, the audio quality of AirPods Pro is much better and natural (but nearing their abilities limit), have an actual microphone for calls (Hearing aids are unidirectional), they are also 3x cheaper than the official hearing aids.

    We cannot wait to see what'll be improved for the update.
    ronnforgot usernameBart Y
  • Reply 8 of 10
    danoxdanox Posts: 3,231member
    mac voyer said:
    How long before AirPods are hit with gatekeeper status? ߘࠉ'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.

    The EU will stick their beak in and claim uncompetitive. In Apples announcements this week they released several new sound/audio API’s all of which will cause Spotify to cry foul, if Spotify doesn’t use the new API’s how will they communicate within Apple ecosystem's on all the multiple devices that Apple currently makes that use sound which all have to be upgraded to use the new AirPods, I don’t think Apple is gonna go backwards this it is too important, and I think the rest of the world is gonna move forward on it outside the EU. Is this malicious innovation? Only in Spotify’s world.

    edited September 13 Bart Y
  • Reply 9 of 10
    danoxdanox Posts: 3,231member

    sakamura said:
    My dad already uses his AirPods Pro 1 as makeshift hearing aids after a suggestion from his doctor. It still helps him have a better hearing and better conversations with people when he occasionally wears them.

    My wife is on the limit of moderate loss. She did the same, but so far she still prefers her smaller hearing aids. They tend to be nearly invisible and will stay locked in no matter the movements, where it's possible to lose the very visible AirPods Pro with a good head shake. Due to size and sealed tips, AirPods Pro also tend to keep moisture trapped, and that can cause issues if worn constantly. Finally, the battery is a few days, vs a few hours, and you need to have your phone nearby.

    On the other side of the coin, the audio quality of AirPods Pro is much better and natural (but nearing their abilities limit), have an actual microphone for calls (Hearing aids are unidirectional), they are also 3x cheaper than the official hearing aids.

    We cannot wait to see what'll be improved for the update.
    What’s gonna be great is the software iteration over time that will be possible.
    sakamuraBart Y
  • Reply 10 of 10
    forgot usernameforgot username Posts: 65member
    sakamura said:
    My dad already uses his AirPods Pro 1 as makeshift hearing aids after a suggestion from his doctor. It still helps him have a better hearing and better conversations with people when he occasionally wears them.

    My wife is on the limit of moderate loss. She did the same, but so far she still prefers her smaller hearing aids. They tend to be nearly invisible and will stay locked in no matter the movements, where it's possible to lose the very visible AirPods Pro with a good head shake. Due to size and sealed tips, AirPods Pro also tend to keep moisture trapped, and that can cause issues if worn constantly. Finally, the battery is a few days, vs a few hours, and you need to have your phone nearby.

    On the other side of the coin, the audio quality of AirPods Pro is much better and natural (but nearing their abilities limit), have an actual microphone for calls (Hearing aids are unidirectional), they are also 3x cheaper than the official hearing aids.

    We cannot wait to see what'll be improved for the update.
    I hope Apple addresses the issues you’ve raised in this new market for AirPods. I bet prototypes are already being developed. Also, I wonder if the battery life of existing AirPods can be extended when used in hearing aid mode.

    By the way, do any hearing aid users keep their aids in while sleeping?
    sakamura
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