Samsung Galaxy Buds receive FDA clearance for hearing aid feature

Samsung has received FDA clearance for a new Hearing Aid feature for its Galaxy Buds, allowing selected models to function as over-the-counter (OTC) hearing aids. The feature is designed for adults aged 18 and older with perceived mild to moderate hearing loss.

Users can perform a self-administered, five-minute hearing test via their Galaxy smartphone. This test uses pure-tone audiometry to create a clinical-grade audiogram, which is then used to personalize sound amplification. The system utilizes the NAL-NL2 fitting formula to boost specific frequencies, such as high-pitched sounds and whispers, while employing beamforming and noise reduction to focus on speech and minimize background interference.

The rollout is expected to begin in the fourth quarter of 2026 for the Galaxy Buds3 Pro and Galaxy Buds4 Pro models. To use these features, a compatible Samsung Galaxy device running One UI 8 or later is required. This development positions Samsung as a direct competitor to Apple, which introduced similar hearing health capabilities for its AirPods in 2024.