FDA clears hearing aid feature on Samsung Galaxy Buds

Samsung introduced the Personal Sound Amplification Product (PSAP) feature on Galaxy Buds+ in 2020 Samsung announced that its Galaxy Buds Hearing Aid feature has received US Food and Drug Administration (FDA) clearance, enabling compatible Galaxy Buds to serve as an over-the-counter (OTC) hearing aid, offering users 18 years and older a convenient solution for addressing perceived mild to moderate hearing loss. Users can also diagnose their hearing with the Galaxy Buds Hearing Test feature, which is registered as a Software as a Medical Device (SaMD) and provides medical-grade results.Commenting on the launch, Hon Pak, Senior Vice President and Head of the Digital Health Team for the Mobile eXperience (MX) Business at Samsung Electronics said “Hearing health is a vital component of our overall well-being, profoundly impacting how we communicate, connect with loved ones and engage with the world,” adding “With the latest clearance from the FDA, we are expanding access to hearing support and making proactive care effortless by integrating the Hearing Test and Hearing Aid functionality directly into the Galaxy Buds.”Samsung introduced a Personal Sound Amplification Product (PSAP) feature on Galaxy Buds+ in 2020. The PSAP feature was clinically validated in 2021 as effective support for daily communication for those with hearing loss.To develop this new OTC solution, Samsung collaborated closely with the National Acoustic Laboratories (NAL) and Samsung Medical Center (SMC). The resulting technology is backed by robust clinical validation studies conducted at Vanderbilt University Medical Center, San Jose State University and the University of Memphis. Based on those results, the Hearing Aid feature amplifies the sounds users have difficulty hearing — such as high frequencies, surrounding whispers and distant voices — personalized to each user’s hearing profile.Samsung said the hearing aid also supports additional advanced features typically found in premium hearing aids, such as noise elimination and beamforming, which help focus sounds in front of the user and suppress background noise. The Hearing Aid and Hearing Test features will be available on Galaxy Buds 3 Pro and Galaxy Buds 4 Pro in the US and select approved markets in Q4 2026.Get the latest technology news and updates. Download the TOI App.