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The FDA authorized Apple’s Hearing Aid Feature on September 12, 2024, as over-the-counter hearing-aid software for compatible AirPods Pro versions. It is intended for adults 18 and older with perceived mild to moderate hearing impairment—not as a blanket approval of all AirPods or a substitute for every kind of hearing aid.
Did the FDA approve AirPods as hearing aids?
Not exactly. The FDA authorized Apple’s Hearing Aid Feature (HAF), a software-only mobile medical application designed to work with compatible wearable products. The authorization covers the software’s use with compatible AirPods Pro hardware; it does not classify every AirPods model as a hearing aid.
FDA records identify the device as Hearing Aid Feature, requested by Apple Inc. under De Novo number DEN230081. The FDA granted the De Novo request on September 12, 2024, and classified the software as a Class II air-conduction hearing aid under 21 CFR 874.3335. The decision letter says the feature is intended to amplify sound for people aged 18 or older with perceived mild to moderate hearing impairment. Read the FDA decision letter or view the FDA De Novo database entry.
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A free scan shows the junk files, broken settings and background clutter dragging Windows down - then fixes them in one click.Free scan · Windows 10 & 11The distinction matters: this is an FDA-authorized hearing-aid software feature used with specified consumer hardware, not a finding that the earbuds alone are a medical device suitable for anyone with hearing loss. FDA’s announcement described it as over-the-counter hearing aid software on a consumer audio product. FDA announcement, September 12, 2024.
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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.*
Who is the feature intended for?
The FDA indication is limited to people 18 years of age or older who perceive that they have mild to moderate hearing impairment. It is not presented as treatment for severe or profound hearing loss, nor does the authorization establish suitability for every cause or pattern of hearing difficulty.
“Perceived” describes the population in the authorization; it does not mean a user has received a diagnosis. If hearing problems are sudden, worsening, one-sided, accompanied by pain or dizziness, or otherwise concerning, seek medical advice rather than relying on a self-fitting feature alone.
Rank #2
- 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
Which AirPods work as hearing aids?
FDA materials refer to compatible versions of AirPods Pro. A later FDA comparison document identifies AirPods Pro 2 as the HAF platform, but the FDA documents cited here do not provide a complete current compatibility matrix for every AirPods generation, firmware, iOS version, or country. Do not assume the feature works with all AirPods Pro models or every software configuration. Check Apple’s current support documentation and device requirements before relying on compatibility.
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How does the AirPods Hearing Aid Feature work?
The feature is self-fitting: an iOS device is used during setup, hearing levels can be accessed from iOS HealthKit, and users can adjust the resulting amplification to their preferences. The FDA decision describes controls for volume, tone, and balance, allowing a user to refine the sound rather than requiring a professional fitting as a condition of the authorized use.
Rank #3
- 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.*
Self-fitting does not mean the result will suit every person or situation. The FDA authorization defines the intended users and the software’s role; individual hearing needs and listening environments can differ.
Independent reader supportYour contribution helps us test, update, and keep practical guides available for everyone.What did the FDA’s clinical study find?
FDA summarized a multi-site U.S. study involving 118 people with perceived mild to moderate hearing loss. In the FDA’s account, participants who self-fit the same device reported similar perceived benefit to those whose device was professionally fitted. The agency also reported comparable performance on specified amplification and speech-in-noise measures, and no device-related adverse events were observed in that study.
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.*
Those findings describe the study FDA reviewed, not a guarantee of benefit or safety for any individual. They also do not show that the feature is equivalent to every prescription hearing aid, or that it will perform equally well for severe hearing loss or in every listening environment.
Quick Recap
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- This pre-owned product is not Apple certified, but has been professionally inspected, tested and cleaned by Amazon-qualified suppliers.
What the authorization does—and does not—establish
- It establishes: FDA authorization of Apple’s HAF software as an over-the-counter hearing aid feature for compatible AirPods Pro use in adults with perceived mild to moderate hearing impairment.
- It does not establish: that every AirPods model is an FDA-authorized hearing aid, that the feature is appropriate for children or all levels of hearing loss, or that it replaces professional evaluation when one is needed.
- Compatibility and availability: The FDA materials cited here do not establish a full current device/software matrix or country-by-country availability. Confirm those details with Apple for the exact device and location.
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.
