Samsung Wins FDA Clearance for Galaxy Buds Hearing Aid Software, Following Apple’s 2024 Path
Updated
Updated · audioxpress.com · Aug 12
Samsung Wins FDA Clearance for Galaxy Buds Hearing Aid Software, Following Apple’s 2024 Path
3 articles · Updated · audioxpress.com · Aug 12
Summary
July 31 FDA records show Samsung cleared a software-only OTC hearing aid feature for Galaxy Buds and Galaxy phones under the Traditional 510(k) pathway, using Apple’s 2024 AirPods authorization as the predicate device.
A 5-minute self-administered hearing test builds an audiogram, then the feature applies NAL-NL2 fitting, beamforming, noise suppression and feedback control to personalize amplification for adults with perceived mild-to-moderate hearing loss.
Clinical validation backed the clearance: a 103-participant multicenter study found Samsung’s self-fit group delivered non-inferior perceived benefit versus clinician fitting, while a 367-participant test study showed a 3.75 dB median absolute difference from clinical audiometry.
The clearance reinforces a broader shift in earbuds from consumer audio accessories to regulated hearing platforms, with the medical device defined as software running across compatible phones and earbuds rather than the hardware alone.