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Yes—but the FDA decision was made on September 12, 2024, not recently. The FDA authorized Apple’s software-based Hearing Aid Feature for use with compatible wearable devices, including AirPods Pro 2. It is intended for adults 18 and older with perceived mild-to-moderate hearing impairment; it is not a blanket approval of AirPods as a replacement for every hearing aid or a medical diagnosis.
What the FDA authorized
The FDA authorized Apple’s Hearing Aid Feature (HAF), a software-only medical application that amplifies sound through compatible wearable electronics. The FDA record identifies Apple Inc. as the applicant and lists the decision under De Novo submission DEN230081, dated September 12, 2024. The device is Class II air-conduction hearing aid software, product code SCR, under 21 CFR 874.3335. The FDA De Novo record and decision letter describe the authorization.
That distinction matters: the authorization concerns the software feature, not a declaration that AirPods Pro 2 hardware is suitable for every person with hearing loss. The feature was developed for compatible Apple devices and AirPods Pro hardware. Apple announced the feature on September 9, 2024; that announcement preceded the FDA decision and is not its date. The FDA announcement uses “authorized.” “FDA-approved” is common shorthand, but “FDA-authorized through the De Novo pathway” is more precise. De Novo is distinct from the traditional 510(k) pathway and established a classification for this novel type of device.
Four features that are easy to confuse
- Hearing Test: A self-administered assessment based on pure-tone audiometry. It produces hearing results for each ear, which can inform personalization; it is not a complete medical evaluation.
- Hearing Aid: The authorized software feature that applies a customized amplification profile using a Hearing Test result or an audiogram from a hearing professional.
- Hearing Protection: A separate feature intended to reduce exposure to loud sounds. It does not serve the same purpose as personalized amplification.
- Accessibility audio controls: General sound adjustments are not the same thing as the regulated, self-fitting Hearing Aid Feature.
Who it is intended for—and when to seek care
The FDA indication is for adults 18 and older with perceived mild-to-moderate hearing impairment. The self-fitting approach lets users adjust the feature without assistance from a hearing professional. That does not mean every adult in that range will get the same benefit, or that the feature is appropriate for hearing loss outside the authorized use. See the FDA’s description of the intended users.
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- WORLD’S BEST IN-EAR ACTIVE NOISE CANCELLATION — Removes up to 2x more unwanted noise than AirPods Pro 2* so you can stay fully immersed in the moment.*
- BREAKTHROUGH AUDIO PERFORMANCE — Experience breathtaking, three-dimensional audio with AirPods Pro 3. A new acoustic architecture delivers transformed bass, detailed clarity so you can hear every instrument, and stunningly vivid vocals.
- HEART RATE SENSING — Built-in heart rate sensing lets you track your heart rate and calories burned for up to 50 different workout types.* With iPhone, you will have access to the Move ring, step count, and the new Workout Buddy,* powered by Apple Intelligence.*
- LIVE TRANSLATION — Communicate across language barriers using Live Translation,* enabled by Apple Intelligence.*
- EXTENDED BATTERY LIFE — Get up to 8 hours of listening time with Active Noise Cancellation on a single charge. Or up to 10 hours in Transparency using the Hearing Aid feature.*
Do not use an earbud feature as a substitute for evaluation when symptoms may have a medical cause. Seek prompt professional care for sudden hearing loss; significant one-sided hearing loss, especially if its cause is unknown; ear pain or drainage; persistent dizziness; or rapidly worsening hearing. Children and people with severe or profound loss, complex or asymmetric hearing profiles, or a need for specialized support should ask a qualified clinician about appropriate options. The Apple instructions for use provide product-specific guidance and warnings.
A self-test can be affected by background noise, earbud placement, or a poor ear-tip fit. If a result seems implausible, repeat the test in suitable conditions or have hearing assessed professionally. A different result in each ear may also warrant individualized advice; the feature should not be assumed to compensate adequately for every uneven hearing profile.
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Which AirPods and regions are covered?
The 2024 FDA authorization story centered on AirPods Pro 2. Apple’s current support materials also reference AirPods Pro 3, but later support for another model should not be read as proof that the original 2024 decision covered every future product. Check the current Apple requirements for the exact AirPods model, operating system, firmware, and region before buying or troubleshooting. Apple’s current setup and compatibility instructions are the place to confirm the supported configuration.
Availability is not universal. Apple says hearing-health features can vary by country or region, language, device model, operating-system version, AirPods firmware, and regulatory authorization. Its feature announcement describes these qualifications. Check Apple’s live Hearing Health Feature Availability information for your location rather than assuming a feature announced in one market works everywhere. Do not rely on changing region settings or traveling to unlock a feature.
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- Active Noise Cancellation reduces unwanted background noise
- Adaptive Transparency lets outside sounds in while reducing loud environmental noise
- Personalized Spatial Audio with dynamic head tracking places sound all around you
- Multiple ear tips (XS, S, M, L)
- Touch control lets you swipe to adjust volume, press to direct media playback, answer or end calls, and press and hold to switch between listening modes
- Confirm the precise AirPods Pro model, not merely that the product is called AirPods.
- Check that your iPhone or iPad and its operating system meet Apple’s current requirements.
- Check regional availability and any language or regulatory limitations.
- Confirm that the feature appears for your paired device before making a purchase specifically for hearing assistance.
How the Hearing Test and Hearing Aid setup work
Apple describes its Hearing Test as a roughly five-minute, self-administered pure-tone test. The result includes hearing information for each ear and can be used to personalize the Hearing Aid Feature. A professional audiogram can also be entered as an alternative. Apple’s original description is in its hearing-health announcement; use the current Apple Support instructions for up-to-date labels and requirements.
- Prepare the devices. Update the compatible iPhone or iPad and AirPods Pro 2 as Apple directs, charge the earbuds, and pair them with the device you intend to use.
- Open the hearing controls. Follow Apple’s current instructions to reach Hearing Health controls from the paired AirPods settings or Health app. Menu labels can change with software updates.
- Take the test in a quiet place. Select Hearing Test and follow the tone prompts without interruption. Check earbud fit if the test cannot be completed or the result seems unreliable.
- Review the result. Look at the findings for both ears. If the result falls outside the intended mild-to-moderate use, or symptoms raise medical concerns, seek professional advice rather than trying to force the feature into use.
- Enable and adjust Hearing Aid. Use the test result, or add an audiogram from a hearing professional if available. Refine the available settings and try the profile in ordinary listening situations at a comfortable level.
What the feature changes—and what it does not
The Hearing Aid Feature uses a hearing profile to customize amplification. Apple says the personalized profile can apply to conversations and other audio, including music, movies, games, and phone calls. The FDA identifies user controls including volume, tone, and balance. This is more specific than simply raising all ambient sound equally, but it does not guarantee that speech will be clear in every setting.
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- REBUILT FOR COMFORT — AirPods 4 have been redesigned for exceptional all-day comfort and greater stability. With a refined contour, shorter stem, and quick-press controls for music or calls.
- PERSONALIZED SPATIAL AUDIO — Personalized Spatial Audio with dynamic head tracking places sound all around you, creating a theater-like listening experience for music, TV shows, movies, games, and more.*
- IMPROVED SOUND AND CALL QUALITY — AirPods 4 feature the Apple-designed H2 chip. Voice Isolation improves the quality of phone calls in loud conditions. Using advanced computational audio, it reduces background noise while isolating and clarifying the sound of your voice for whomever you’re speaking to.*
- MAGICAL EXPERIENCE — Just say “Siri” or “Hey Siri” to play a song, make a call, or check your schedule.* And with Siri Interactions, now you can respond to Siri by simply nodding your head yes or shaking your head no.* Pair AirPods 4 by simply placing them near your device and tapping Connect on your screen.* Easily share a song or show between two sets of AirPods.* An optical in-ear sensor knows to play audio only when you’re wearing AirPods and pauses when you take them off. And you can track down your AirPods and Charging Case with the Find My app.*
- LONG BATTERY LIFE — Get up to 5 hours of listening time on a single charge. And get up to 30 hours of total listening time using the case.*
In noisy rooms, performance still depends on factors such as fit, microphone placement, reverberation, and the distance between the listener and speaker. A study result showing comparable performance on a speech-in-noise measure is not a promise that every crowded restaurant or meeting will become easy to follow. Hearing Protection, meanwhile, addresses loud-sound exposure; it should not be mistaken for a hearing-aid setting.
Independent reader supportYour contribution helps us test, update, and keep practical guides available for everyone.What the FDA’s clinical evidence shows
The FDA reported a clinical study involving 118 subjects with perceived mild-to-moderate hearing loss at multiple U.S. sites. In the study, self-fitting users reported similar perceived benefit to users who received professional fitting of the same device. The FDA also reported comparable results for in-ear amplification measurements and a speech-in-noise measure, with no device-related adverse events observed in the study. The findings are summarized in the FDA announcement and its De Novo review.
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- REBUILT FOR COMFORT — AirPods 4 have been redesigned for exceptional all-day comfort and greater stability. With a refined contour, shorter stem, and quick-press controls for music or calls.
- ACTIVE NOISE CANCELLATION — AirPods 4 with Active Noise Cancellation help reduce outside noise before it reaches your ears, so you can immerse yourself in what you’re listening to.*
- HEAR THE WORLD AROUND YOU — The powerful H2 chip comes to AirPods 4. Adaptive Audio seamlessly blends ANC and Transparency mode — which lets you comfortably hear and interact with the world around you exactly as it sounds — to provide the best listening experience in any environment.* And when you’re speaking with someone nearby, Conversation Awareness automatically lowers the volume of what’s playing.*
- IMPROVED SOUND AND CALL QUALITY — Voice Isolation improves the quality of calls in loud conditions. Using advanced computational audio, it reduces background noise while isolating and clarifying the sound of your voice for whomever you’re speaking to.*
- MAGICAL EXPERIENCE — Just say “Siri” or “Hey Siri” to play a song, make a call, or check your schedule.* And with Siri Interactions, now you can respond to Siri by simply nodding your head yes or shaking your head no.* Pair AirPods 4 by simply placing them near your device and tapping Connect on your screen.* Easily share a song or show between two sets of AirPods.* An optical in-ear sensor knows to play audio only when you’re wearing AirPods and pauses when you take them off. And you can track down your AirPods and Charging Case with the Find My app.*
Those results support the feature for its specified intended use. They do not establish equivalence to every conventional hearing aid, superiority over professionally fitted devices, or equal benefit for people with different degrees or causes of hearing loss. The study population and test conditions also cannot stand in for every listener, environment, or preference. “Clinical-grade,” when used in Apple’s product description, should not be taken to mean that the feature has been shown to outperform all hearing aids.
AirPods Pro 2 or conventional hearing aids?
AirPods Pro 2 may suit someone with mild-to-moderate hearing difficulty who already uses compatible Apple equipment, wants occasional or situational amplification, and is comfortable managing earbuds, charging, settings, and updates. A purpose-built hearing aid may be a better match for someone who needs all-day hearing support, professional fitting and follow-up, or specialized features. Neither category is automatically right for every person.
| Consideration | AirPods Pro 2 with Hearing Aid Feature | Professionally fitted hearing aids |
|---|---|---|
| Fitting | Self-fitting from a Hearing Test result or entered audiogram; user adjustments include volume, tone, and balance. | Professional evaluation and fitting are available; real-ear verification and ongoing support depend on the provider and device. |
| Typical use case | Adults with perceived mild-to-moderate impairment who want amplification alongside earbud functions. | Can be considered when needs are more complex or require individualized clinical support. |
| Specialized needs | Do not assume support for custom earmolds, telecoil, pediatric fitting, or advanced individualized programs. | Options may include custom earmolds, tinnitus programs, telecoil or hearing-loop compatibility, and other capabilities; confirm with the clinician and model. |
| Power and wear | Earbud design with regular charging; convenient if the user already carries and uses the Apple devices. | Purpose-built devices may be designed for long-term hearing-aid use; battery life and form vary by model. |
| Cost context | The software feature is delivered without a separate hearing-aid subscription in Apple’s launch description, but compatible AirPods and Apple hardware are required. A current price is not stated in the cited sources. | Price, included fitting and follow-up, warranty, repair, and coverage vary; the cited sources do not establish a comparable cost. |
A fair cost comparison includes more than the feature’s software price: compatible AirPods, a compatible iPhone or iPad, replacement accessories, future hardware replacement, and any professional care may all matter. Apple’s launch description does not make this “free hearing care.” The official AirPods Pro product page can help identify current hardware, but confirm model-level feature support and local availability separately.
When the feature is missing or the test fails
- Check the model. Confirm you have a supported AirPods Pro model; standard AirPods or AirPods 4 should not be assumed to support this feature.
- Check connection and software. Connect the AirPods to the intended iPhone or iPad and install available operating-system updates. Follow Apple’s instructions for firmware updates; allow time for the earbuds to update while charging near the paired device.
- Check availability. Verify your country or region, device configuration, and language against Apple’s current support information.
- Reconnect and retry. Restart or reconnect the AirPods, then revisit the Hearing Health controls.
- Improve test conditions. Move to a quieter room, check that the ear tips fit and the earbuds are correctly placed, and repeat the test if appropriate.
- Do not work around an unsuitable result. If the result is outside the supported range, or the test repeatedly fails, contact Apple Support for device issues or a hearing professional for hearing concerns.
Apple’s support page is the authoritative source for current device steps and compatibility; the available controls may change as software and supported models change.
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