Samsung Electronics secured U.S. Food and Drug Administration (FDA) clearance for its Galaxy Buds hearing aid feature. This functionality allows compatible Galaxy Buds to serve as over-the-counter (OTC) hearing aids for adults aged 18 and older. The feature targets individuals with perceived mild to moderate hearing loss and does not require a prescription.
The system includes a Software as a Medical Device (SaMD)-registered Hearing Test feature. This tool provides users with a medical-grade assessment to personalize sound amplification based on clinical standards.
This development expands Samsung’s footprint in the digital health sector by integrating medical support into consumer electronics. Hon Pak, Head of the Digital Health Team at Samsung, stated the move makes proactive hearing care more accessible and effortless for consumers.