Samsung's Galaxy Buds 3 Pro and 4 Pro are getting FDA-cleared hearing aid features

By: Anton Kratiuk | yesterday, 21:51

Samsung's Galaxy Buds 3 Pro and 4 Pro will gain FDA-cleared hearing aid capabilities before the end of 2026, the company announced via Samsung Mobile Press. The update adds a clinical-grade hearing test and personalized sound amplification, both free with no subscription attached. For anyone managing mild-to-moderate hearing loss, this could make a meaningful difference — private hearing aids in the UK run from £495 to £3,500 per ear, per TreatCompare.

The features

Two new functions roll out as part of the update. Hearing Test runs a five-minute audiometry check — the same kind done in a clinic — and maps hearing ability for each ear separately. The test uses the NAL-NL2 fitting formula, a globally recognized clinical standard developed with Australia's National Acoustic Laboratories and validated at Vanderbilt, San Jose State, and Memphis universities.

Hearing Aid then takes those results and adjusts amplification in real time, tuning what you hear in conversation, music, or ambient sound to match your specific profile. Both features live inside the Samsung Health app and also include noise reduction and beamforming — a technique that focuses the microphone on the sound directly in front of you. No prescription or audiology appointment needed; the only requirements are a Galaxy phone running One UI 8 or later and being 18 or older.

The catch for UK buyers

The FDA clearance covers the US. Samsung says the rollout will reach "select approved markets" in Q4 2026, but has not confirmed which countries outside the US qualify. UK market eligibility is unconfirmed as of now, and EU regulatory approval — which follows a separate pathway involving CE marking — has not been announced.

That matters for context. Apple's AirPods Pro 2 already offer hearing aid features in some regions after FDA clearance, and Samsung is now matching that standard. But availability in the UK, where NHS hearing aids are free but involve waiting lists and limited models, could make this update genuinely significant — if and when it arrives. Watch for Samsung's market-specific announcements closer to the Q4 window.