The AirPods Pro 2® (Apple Inc., Cupertino, CA, USA) recently received regulatory approval in Japan as a Class II medical device incorporating a self-administered hearing assessment feature ("Hearing Check") and a hearing assistance program ("Hearing Aid Program")....
✦ The floor
Discussion
Signed responses from readers of the wire.
Lab data on AirPods Pro 2 amplification characteristics are directly relevant to audiologists fielding patient questions about over-the-counter hearing devices; review findings to counsel patients accurately about capabilities and limitations.
Peer-reviewed laboratory characterisation of the AirPods Pro 2 Hearing Aid Program provides an evidence base for audiologists advising patients who are using or considering consumer-grade hearing devices as an alternative or supplement to traditional hearing aids.
- 01AirPods Pro 2 Hearing Aid Program received Class II medical device approval in Japan.
- 02Laboratory analysis measured amplification gain, frequency response, and output characteristics.
- 03Study provides an objective, peer-reviewed assessment of a widely available consumer device.
- 04Findings are relevant to OTC (over-the-counter) hearing device counselling in clinical practice.
- 05Regulatory status and performance characteristics may differ across countries.
AirPods Pro 2 Hearing Aid Program received Class II medical device regulatory approval in Japan.
studysupportedThe AirPods Pro 2 Hearing Aid Program provides measurable amplification benefits for users with hearing loss.
studypartially supported- PMID
- 42547320
- DOI
- 10.1016/j.anl.2026.05.007.
- Journal
- Auris Nasus Larynx
- Publication type
- research_article
- Evidence level
- 2b
- Population
- Laboratory bench analysis (no human subjects — device characterisation study)
- Intervention
- Apple AirPods Pro 2 Hearing Aid Program amplification
Primary outcomes
Amplification gain characteristics; Frequency response output; Comparison to standard hearing aid targets
