Samsung to add FDA-approved hearing aid features to Galaxy Buds Pro series
Samsung plans to roll out hearing aid capabilities for its Galaxy Buds 3 Pro and Buds 4 Pro earbuds in early 2027 following regulatory approvals in the U.S. and South Korea.
Samsung is expanding the functionality of its premium wireless earbuds by integrating clinical-grade hearing aid software. The company confirmed that the Galaxy Buds 3 Pro and Galaxy Buds 4 Pro have received approval from the U.S. Food and Drug Administration (FDA) and South Korea’s Ministry of Food and Drug Safety to operate as digital medical devices.
The feature suite includes "Hearing Check" and "Hearing Care" functions, which allow users to perform clinical-grade pure-tone audiometry directly through a connected Galaxy smartphone. By measuring the minimum sound intensity audible to the user across different frequencies, the system generates a personalized audiogram and categorizes hearing loss into six levels, ranging from normal to profound.
For hearing amplification, the devices utilize the NAL-NL2 fitting formula developed by Australia’s National Acoustic Laboratories. This clinical standard allows the earbuds to selectively amplify specific frequency bands, targeting the needs of users with mild to moderate hearing loss. Samsung positions this as a self-managed tool for individuals aged 18 and older, though the company emphasizes that these software features do not replace professional medical diagnostics or clinical consultations.