Assistive Listening Knowledge Base
  • Regulatory announcement

FDA Authorizes First Over-the-Counter Hearing Aid Software

From https://assistivelisteningknowledgebase.org/evidence/fda-2024-hearing-aid-software/ · record checked 13 October 2026

  • US Food and Drug Administration

Government (FDA account of Apple's authorization; study funding is not stated in this announcement)

Summary

FDA authorization of Apple's Hearing Aid Feature for compatible AirPods Pro, for adults with perceived mild to moderate hearing loss.

Key findings

  • The feature turns compatible AirPods Pro into an over-the-counter hearing aid for people aged 18 or older, with self-fitting through an iOS device.
  • FDA reports a 118-person study at multiple US sites: self-fitting and professional fitting of the same device gave similar perceived benefit and comparable ear-canal amplification and speech-in-noise results.

Limits

Regulatory summary, not the full clinical report. Funding and detailed results are absent. It compares fittings of the same device, not AirPods against venue receivers, and establishes no venue-broadcast compatibility.

Read the original

www.fda.gov/news-events/press-announcements/fda-authorizes-first-over-counter-hearing-aid-software

Link checked . We link to the original and do not host copies.

Cited in

Cite this source

US Food and Drug Administration. FDA Authorizes First Over-the-Counter Hearing Aid Software. 12 September 2024. https://www.fda.gov/news-events/press-announcements/fda-authorizes-first-over-counter-hearing-aid-software (accessed 13 October 2026).

The accessed date is when this library last checked the link; use the date you read it. To point readers to this summary instead, link to https://assistivelisteningknowledgebase.org/evidence/fda-2024-hearing-aid-software/

Every finding here cites its source, and who funded each source is labelled. This site does not recommend products. Found an error or a missing study? Suggest a correction.