Samsung has secured FDA approval for a built-in hearing aid function in selected Galaxy Buds, signaling a significant shift towards accessible over-the-counter hearing support for adults with mild to moderate hearing loss, and positioning the tech giant ahead of competitors like Apple.
Samsung has won US Food and Drug Administration clearance for a hearing aid function built into selected Galaxy Buds, moving the earbuds further into the growing OTC hearing support market. The company said the feature is intended for adults aged 18 and over with perceived mild to moderate hearing loss and can be used without a prescription or clinic appointment. In practical terms, it gives Samsung users a consumer-device route to basic hearing assistance at a time when manufacturers are trying to make hearing support easier to access and less visibly medical. According to the FDA, OTC hearing aids are designed for adults with perceived mild to moderate hearing loss and are available without the involvement of a licensed professional.
The system centres on two tools embedded in the Galaxy Buds interface. Users can run a self-administered hearing test from the buds settings menu, and Samsung says the process takes about five minutes. The test uses pure-tone audiometry to assess each ear separately and generates an audiogram, with results placing hearing into categories from normal through to profound loss. The hearing aid mode then adjusts amplification to the user’s profile, with the aim of making high frequencies, whispers and distant speech easier to hear. Samsung says the software also applies noise reduction and beamforming to improve speech focus in louder environments.
Samsung’s approach follows a path already established by Apple, which became the first company to secure FDA authorisation for OTC hearing aid software for AirPods Pro. Android Central reported that Samsung’s newly cleared hearing aid feature will first appear on the Galaxy Buds 3 Pro and Galaxy Buds 4 Pro, with a launch expected in the fourth quarter of 2026 in the United States and selected other markets. TechRadar added that the feature is designed to work inside Samsung’s wider software stack, requiring a Samsung phone running One UI 8 or later.
The company has been building towards this for years. Samsung first introduced a personal sound amplification mode on the Galaxy Buds+ in 2020, and that feature was later clinically validated in 2021 for daily communication support. For the new hearing aid mode, Samsung worked with the National Acoustic Laboratories and Samsung Medical Centre, while validation studies were carried out at Vanderbilt University Medical Centre, San Jose State University and the University of Memphis, according to the company’s announcement. Samsung also points to the scale of unmet need: the World Health Organisation estimates that more than 1.5 billion people live with some degree of hearing loss, a figure it expects to rise sharply by 2050.
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