Samsung’s Hearing Aid Feature on Galaxy Buds Cleared by FDA
Samsung’s Galaxy Buds Hearing Aid feature has received FDA clearance as an over-the-counter hearing aid for adults with mild to moderate hearing loss, eliminating the need for a prescription.
Samsung Electronics announced that the Galaxy Buds Hearing Aid feature has received clearance from the U.S. Food and Drug Administration (FDA), allowing users aged 18 and older to use compatible Galaxy Buds as over-the-counter hearing aids for perceived mild to moderate hearing loss. The feature does not require a prescription or in-person clinic visit, addressing accessibility barriers such as cost and limited professional care. Samsung’s announcement follows clinical validation studies conducted at Vanderbilt University Medical Center, San Jose State University, and the University of Memphis, with collaboration from the National Acoustic Laboratories and Samsung Medical Center.
The Galaxy Buds Hearing Aid feature integrates directly into the Galaxy Buds menu within device settings, enabling users to perform a self-administered Hearing Test in approximately five minutes. The test uses clinical-grade pure-tone audiometry to evaluate each ear individually and generates an audiogram comparable to a professional audiologist’s assessment. Results categorize hearing levels as normal, mild, moderate, severe, or profound, providing a personalized hearing profile for the Hearing Aid feature to amplify specific frequencies and sounds the user struggles to hear.
The Hearing Aid feature includes advanced capabilities such as noise elimination and beamforming, which focus on sounds in front of the user while suppressing background noise. It employs the NAL-NL2 formula, a globally recognized clinical standard for fitting prescription hearing aids, ensuring personalized and accurate amplification tailored to individual hearing profiles.
Samsung’s hearing health experience also includes hearing-related insights within the Samsung Health app, such as noise exposure levels and Hearing Test results. The company has emphasized its commitment to hearing support since 2020, when it introduced a Personal Sound Amplification Product (PSAP) feature on Galaxy Buds+, which was clinically validated in 2021.