Do these 3 things before closing this tab:
1Fix the driver behind crashes, sound loss and screen glitches2Repair Windows errors before they cause bigger problems3Scan for outdated or missing drivers - takes under a minuteAirPods Pro 2 can provide hearing assistance through Apple’s Hearing Aid Feature, software the FDA authorized in 2024 for compatible AirPods Pro. Apple calls its hearing tools “clinical-grade,” but that is Apple’s wording—not a distinct FDA classification or a claim that the earbuds replace every hearing aid or professional service.
The feature is intended for adults aged 18 or older with perceived mild-to-moderate hearing impairment. Its setup uses results from Apple’s Hearing Test or an audiogram from a hearing professional, and availability varies by country or region.
What Apple announced—and what the FDA authorized
Apple announced its hearing features on September 9, 2024. On September 12, 2024, the U.S. Food and Drug Administration announced marketing authorization for the Hearing Aid Feature, an over-the-counter hearing-aid software device for use with compatible Apple AirPods Pro. The FDA reviewed it through the De Novo pathway.
The authorized item is software used with compatible hardware. The FDA did not authorize every AirPods model or every Apple audio feature, and its authorization does not mean the feature is appropriate for every type or degree of hearing loss. In this article, “FDA-authorized” describes the Hearing Aid Feature for its stated intended use—not a blanket endorsement of Apple’s marketing claims or a guarantee of individual results.
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#1 Best Overall
- 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.*
Apple uses the phrase “clinical-grade.” Its announcement and technical materials describe validation of the Hearing Test against traditional pure-tone audiometry. That evidence can be described specifically, but “clinical-grade” is not a distinct FDA classification in the cited materials.
How the Hearing Aid feature works
The Hearing Aid Feature uses hearing results to personalize amplification. A user can set it up with results from Apple’s Hearing Test or an audiogram from a hearing professional, then adjust amplification, balance, and tone.
Apple says the personalized settings can be used with everyday audio, including:
- Phone calls
- Music
- Movies
- Games
The feature relies on compatible AirPods Pro hardware and software, as well as a compatible Apple device for setup. It changes how sound is processed and presented; it does not make the product suitable for hearing loss outside its authorized intended use.
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Rank #2
- 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.*
Hearing Test and Hearing Aid are different
Apple’s Hearing Test and Hearing Aid Feature are related but not interchangeable. The test estimates hearing thresholds and produces results; the Hearing Aid Feature uses hearing results to personalize amplification.
| Feature | What it does | Important limitation |
|---|---|---|
| Hearing Test | Uses pure-tone testing to estimate hearing thresholds and produce results. | It is not the same as a comprehensive diagnostic examination. |
| Hearing Aid | Uses hearing results to personalize amplification through compatible AirPods Pro. | It is intended for adults with perceived mild-to-moderate hearing impairment; availability varies by region. |
| Hearing Protection | Is a separate hearing-related feature described by Apple for compatible hardware and software. | Do not treat it as certified protection for every hazardous-noise setting. |
What the Hearing Test result tells you
Apple says its Hearing Test is based on pure-tone audiometry and was validated against traditional pure-tone audiometry. Results can be used to help personalize the Hearing Aid Feature. A tone-based test is not a comprehensive diagnostic examination, and hearing concerns may need assessment by a hearing healthcare professional.
Who is the feature for?
The FDA describes the intended population as people aged 18 or older with perceived mild-to-moderate hearing impairment. That is narrower than saying AirPods Pro can address all hearing loss. The cited evidence does not establish that the feature is appropriate for every hearing profile or equivalent to every prescription hearing aid.
If you have concerns about your hearing or are unsure whether this feature suits your needs, seek appropriate guidance from a hearing healthcare professional. Do not rely on the feature as a diagnosis or let it delay care.
Rank #3
- Active Noise Cancellation blocks outside noise, so you can immerse yourself in music
- Transparency mode for hearing and interacting with the world around you
- Spatial audio with dynamic head tracking places sound all around you
- Adaptive EQ automatically tunes music to your ears
- Three sizes of soft, tapered silicone tips for a customizable fit
What the FDA study found
The FDA reported a multisite U.S. clinical study involving 118 subjects with perceived mild-to-moderate hearing impairment. The FDA said participants who self-fitted reported similar perceived benefit to participants professionally fitted with the same device. In-ear amplification and speech-understanding-in-noise measures were comparable, and no device-related adverse events were observed in that study.
These results support the specific authorization and comparisons reported by the FDA; they do not establish universal equivalence to all hearing aids, outcomes for every user, or long-term comparative performance. The study findings described here are from the FDA’s report, not evidence of independent replication.
Compatibility and regional availability
Apple’s current support documentation says setup requires AirPods Pro 2 with current firmware and an iPhone or iPad running current software. A user can set up from Apple’s Hearing Test or results from a hearing professional. Apple says availability varies by country or region, so check its support information for current local requirements.
- Confirm the AirPods: The feature requires compatible AirPods Pro; this article concerns AirPods Pro 2.
- Update software: Use current AirPods firmware and a compatible iPhone or iPad running current software, as Apple specifies.
- Prepare hearing results: Set up with Apple’s Hearing Test or an audiogram from a hearing professional.
- Check your region: Confirm that the feature is available where you live.
A U.S. FDA authorization should not be read as worldwide approval. Apple’s support documentation is the source to check for current setup details and regional availability.
Rank #4
- 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.*
Choosing AirPods Pro 2 for hearing assistance
If hearing assistance is your main reason for considering AirPods Pro 2, first check whether the feature is available in your region and whether you have the compatible Apple device and current software needed for setup. The product is not a substitute for choosing a hearing solution based on your individual needs.
When comparing hearing-support options, consider the intended degree and type of hearing loss, access to professional assessment and fitting, fit and comfort, speech understanding in the situations that matter to you, ongoing adjustment and follow-up, device and regional compatibility, and current price or coverage. The research reviewed here does not establish a broad head-to-head ranking or comparative price.
Independent reader supportYour contribution helps us test, update, and keep practical guides available for everyone.What “clinical-grade” does—and does not—mean
The most precise summary is that the FDA authorized Apple’s Hearing Aid Feature software for use with compatible AirPods Pro as an over-the-counter hearing-aid software device, intended for adults with perceived mild-to-moderate hearing impairment. Apple’s “clinical-grade” wording should be attributed to Apple and explained through the particular validation and study evidence available.
That does not mean:
- The FDA classified “clinical-grade” as a distinct category or endorsed every Apple hearing claim
- AirPods Pro diagnose all hearing loss
- They replace a hearing healthcare professional for every user
- They are equivalent to all prescription hearing aids
- The feature is available in every country
FAQ
Are AirPods Pro 2 FDA approved as hearing aids?
The FDA’s announcement says it authorized the Hearing Aid Feature software for use with compatible Apple AirPods Pro through the De Novo pathway. “FDA-authorized” is the precise wording used in the announcement.
Best Value
- This pre-owned product is not Apple certified, but has been professionally inspected, tested and cleaned by Amazon-qualified suppliers.
What does “clinical-grade” mean for AirPods Pro 2?
It is Apple’s wording, not a distinct FDA classification in the cited sources. Apple describes the Hearing Test as based on pure-tone audiometry and validated against traditional pure-tone audiometry; the FDA separately reports the evidence for the Hearing Aid Feature’s authorization.
Can AirPods Pro 2 replace hearing aids?
Not universally. The authorized feature is intended for adults with perceived mild-to-moderate hearing impairment, and the FDA-reported study compared self-fitting with professional fitting of the same device—not with every hearing aid or every user’s needs.
Who can use the AirPods hearing aid feature?
The FDA describes it as intended for people aged 18 or older with perceived mild-to-moderate hearing impairment. If you have hearing concerns or are unsure whether it is appropriate for you, consult a hearing healthcare professional.
Do I need an iPhone to use AirPods Pro 2 as a hearing aid?
Apple’s current support documentation says setup requires a compatible iPhone or iPad running current software, as well as AirPods Pro 2 with current firmware. Check Apple Support for current compatibility and regional availability.
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Sources
- U.S. Food and Drug Administration, “FDA Authorizes First Over-the-Counter Hearing Aid Software,” September 12, 2024
- Apple Support, “Use hearing health features with AirPods Pro 2 or AirPods Pro 3”
- Apple, “Using AirPods Pro 2 with iPhone and iPad to Help Protect, Assess, and Assist Hearing,” October 2024
- Apple, “Apple introduces groundbreaking health features to support conditions impacting billions of people,” September 9, 2024
Product prices and availability are accurate as of the date/time indicated and are subject to change. Any price and availability information displayed on Amazon at the time of purchase will apply.
