US FDA Approves Samsung Galaxy Buds Hearing Assistance for Mild to Moderate Hearing Loss

The US Food and Drug Administration has formally approved the hearing assistance feature on Samsung Electronics' Galaxy Buds smart earbuds. The feature has been certified as an over-the-counter medical assistance solution for adults aged 18 and above. Currently, the Galaxy Buds3 Pro and Buds4 Pro support the feature. Users can complete a clinical-grade pure-tone audiometry test through the Samsung Health app on their mobile devices, which generates an audiogram containing detailed hearing data for both ears and classifies hearing status as mild, moderate, severe, or profound. The hearing assistance algorithm applies amplification compensation to specific frequency bands based on the user's individual hearing profile. Combined with noise reduction and beamforming technology, the device can focus on sounds directly in front of the user while reducing background noise.

The solution is primarily aimed at people with mild to moderate hearing loss, such as users who struggle to follow conversations in noisy environments. The hearing assistance feature is delivered in the form of conventional wireless earbuds, allowing users to complete the setup through a low-cost and convenient hearing assessment process without the need for professional hearing aids.