Samsung has secured FDA approval to transform its Galaxy Buds into over-the-counter hearing support devices, marking a significant shift towards mainstream health technology integration and offering a new option for adults with mild to moderate hearing loss.
Samsung has won US Food and Drug Administration clearance for a hearing support feature in its Galaxy Buds line, moving wireless earbuds further into the health tech space. The approval allows compatible Galaxy Buds to operate as over-the-counter hearing aids for adults with perceived mild to moderate hearing loss, a category the FDA says is intended for people aged 18 and over who want to manage hearing needs without a prescription or direct clinical supervision.
The feature centres on a built-in hearing test that Samsung says takes about five minutes and evaluates each ear separately. Using pure-tone audiometry, the system creates an audiogram that maps hearing ability across frequencies and classifies results from normal to profound loss. Samsung then uses that profile to tailor amplification, with the company saying the aim is not simply to make everything louder but to lift sounds the listener is most likely to miss, such as high-frequency speech cues, whispers and voices at a distance.
Samsung is also adding processing designed to improve speech understanding in noisy places. The company says the hearing aid mode includes noise elimination and beamforming, a technique that directs focus towards sound coming from in front of the wearer. Hearing information will be surfaced in Samsung Health, where users can review test results and noise exposure data. The full experience requires a compatible Galaxy device running One UI 8 or later.
The feature builds on Samsung’s earlier hearing-related work, including the Personal Sound Amplification Product function it introduced on Galaxy Buds+ in 2020 and later said had been clinically validated in 2021 for everyday communication support. For the new system, Samsung worked with the National Acoustic Laboratories and Samsung Medical Centre, with clinical validation also involving Vanderbilt University Medical Centre, San Jose State University and the University of Memphis. Samsung says the FDA-cleared hearing test and hearing aid features will reach Galaxy Buds3 Pro and Galaxy Buds4 Pro in the US and selected approved markets in the fourth quarter of 2026, although availability will vary by country and paired device.
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