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The FDA authorized Apple’s Hearing Aid Feature on September 12, 2024, as over-the-counter hearing-aid software for adults 18 and older with perceived mild to moderate hearing impairment. The authorization is for the software used with compatible AirPods Pro—not for all AirPods as standalone medical devices.
Did the FDA approve AirPods as hearing aids?
Not exactly. The FDA’s De Novo database records the device as the Hearing Aid Feature (HAF), requested by Apple Inc. under De Novo number DEN230081; the decision was granted September 12, 2024. The decision letter classifies it as Class II air-conduction hearing aid software under 21 CFR 874.3335. FDA De Novo database entry · FDA decision letter
The FDA’s indication says: “The Hearing Aid Feature is a software-only mobile medical application that is intended to be used with compatible wearable electronic products. The feature is intended to amplify sound for individuals 18 years of age or older with perceived mild to moderate hearing impairment.” FDA decision letter, September 12, 2024
In its announcement, the agency described the authorization as an over-the-counter hearing-aid software feature on a consumer audio product. Michelle Tarver, then acting director of FDA’s Center for Devices and Radiological Health, said the authorization was a step toward making hearing support more available and acceptable for adults with perceived mild to moderate hearing loss. FDA announcement, September 12, 2024
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Which AirPods work with the feature?
The FDA’s original announcement refers to “compatible versions” of AirPods Pro rather than naming every supported model. A later FDA comparison document identifies AirPods Pro 2 as the HAF hardware platform. That supports identifying AirPods Pro 2, but does not establish that every AirPods generation or software configuration is compatible. FDA announcement · FDA comparison document
The FDA materials cited here do not give a current, complete compatibility matrix, minimum operating-system requirements, or country-by-country availability. Check Apple’s current support information for device and software requirements before relying on the feature.
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How does the AirPods hearing aid feature work?
It is a self-fitting feature: an iOS device is used for setup, hearing levels can be accessed from iOS HealthKit, and users can adjust volume, tone, and balance to refine the listening experience. The FDA’s authorization describes the software’s intended use; it does not mean the earbuds automatically provide the right settings for every person or situation.
Independent reader supportYour contribution helps us test, update, and keep practical guides available for everyone.What did the FDA’s clinical evidence show?
The FDA summarized a multi-site U.S. study involving 118 people with perceived mild to moderate hearing loss. In that study, the agency reported similar perceived benefit for people who self-fitted and people professionally fitted with the same device, as well as comparable performance on specified amplification and speech-in-noise measures. No device-related adverse events were observed in the study. FDA announcement
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Those results describe the study FDA summarized, not a guarantee of benefit or safety for every individual. They also do not establish equivalence to every prescription hearing aid, effectiveness for severe hearing loss, or results in every listening environment.
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- Powerful Pass-Through Charging: Supports up to 85W pass-through charging so you can power up your laptop while you use the hub. Note: Pass-through charging requires a charger (not included). Note: To achieve full power for iPad, we recommend using a 45W wall charger.
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Who is the feature intended for—and what does the authorization not establish?
- Intended population: Adults aged 18 or older with perceived mild to moderate hearing impairment.
- Not a universal AirPods claim: The authorization concerns HAF software used with compatible wearable products, with AirPods Pro identified in FDA materials; it does not authorize every AirPods model as a hearing aid.
- Not a claim for all degrees of hearing loss: The stated indication is limited to perceived mild to moderate impairment.
- Not proof of equivalence across hearing aids or settings: The summarized study compared self-fitting with professional fitting of the same device and reported results on specified measures.
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