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# Apple AirPods Hearing Software Authorized
- URL: https://www.fdaweb.com/apple-airpods-hearing-software-authorized/
- Published: 2024-09-12T12:00:00.000Z
- Updated: 2026-09-14T14:41:07.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5157761

FDA has authorized the first over-the-counter hearing and software device that is used with compatible versions of the Apple AirPods Pro headphones. An agency [statement](https://www.fda.gov/news-events/press-announcements/fda-authorizes-first-over-counter-hearing-aid-software?ref=fdaweb.com) says that the authorized Apple Hearing Aid Feature (HAF) enables compatible versions of the AirPods Pro to operate as an over-the-counter hearing aid to amplify sounds for individuals aged 18 or older with perceived mild to moderate hearing impairment.

The statement says the HAF is a software-only mobile medical application that uses a self-fitting strategy so users can adjust it to meet their hearing needs without the assistance of a hearing professional. Users set up the HAF on an iPhone or iPad and the hearing levels are accessed from the iOS HealthKit to customize the HAF by refining the volume, tone, and balance settings.

FDA says the HAF was evaluated in a clinical study with 118 subjects with perceived mild to moderate hearing loss at multiple U.S. sites. The results demonstrated that subjects who used the HAF self-fitting strategy achieved similar perceived benefit as subjects who received professional fitting of the same device, it says. Results also showed a comparable performance on tests measuring levels of amplification in the ear canal, as well as a measure of speech understanding in noise. No adverse events related to the device were observed in the study, FDA says.

The application was reviewed under FDA’s *De Novo* premarket review pathway.