Samsung Galaxy Buds receive FDA approval for hearing aid functionality

Samsung Electronics has announced that the hearing aid functionality for its Samsung Galaxy Buds has received approval from the U.S. Food and Drug Administration (FDA). This allows specific models to function as over-the-counter (OTC) hearing aids for adults aged 18 and older experiencing mild to moderate hearing loss, without requiring a prescription or medical consultation.

The feature set includes a self-administered hearing test that takes approximately five minutes to measure both ears individually. Based on the results, the software creates an audiogram to classify hearing levels. The hearing aid function then uses this profile to amplify difficult-to-hear sounds, such as high-frequency tones or distant voices, while utilizing noise reduction and beamforming technologies to minimize background interference.

The service is expected to roll out in the fourth quarter of 2026 in the United States and other approved regions. The functionality will be available for the Samsung Galaxy Buds3 Pro and Samsung Galaxy Buds4 Pro models, provided they are paired with a Samsung Galaxy device running One UI 9 or later.