FDA clears Samsung Galaxy Buds as over-the-counter hearing aids

Samsung announced Tuesday that its Galaxy Buds Hearing Aid feature has received clearance from the U.S. Food and Drug Administration, allowing compatible earbuds to function as over-the-counter hearing aids for adults with perceived mild to moderate hearing loss.news.samsung

The feature, which requires no prescription or clinic visit, will be available on Galaxy Buds 3 Pro and Galaxy Buds 4 Pro in the U.S. and select approved markets in Q4 2026.engadget+1

How It Works

Samsung's hearing health system combines two features: a self-administered Hearing Test and the Hearing Aid function itself. The Hearing Test, registered as a Software as a Medical Device, uses clinical-grade pure-tone audiometry to evaluate each ear individually in about five minutes, generating an audiogram that categorizes hearing as normal or across four stages of loss — mild, moderate, severe, or profound.digitaltrends+1

Based on those results, the Hearing Aid feature amplifies sounds the user struggles to hear, such as high frequencies, distant voices, and whispers. It also incorporates noise elimination and beamforming to suppress background noise and focus on audio from in front of the wearer.news.samsung+1

Samsung says the system uses NAL-NL2, a clinical standard formula for fitting prescription hearing aids, to personalize amplification for each user's profile.digitaltrends+1

Building on Years of Development

Samsung has been working toward this capability since 2020, when it introduced a Personal Sound Amplification feature on Galaxy Buds+. The company collaborated with the National Acoustic Laboratories, Samsung Medical Center, and conducted clinical validation studies at Vanderbilt University Medical Center, San Jose State University, and the University of Memphis.news.samsung

"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," said Hon Pak, Samsung's Senior Vice President and Head of the Digital Health Team.news.samsung

Apple ↘ 1.09% already offers a similar experience through its AirPods Pro lineup, and Samsung's move places it in direct competition in the growing OTC hearing aid space. The World Health Organization estimates that more than 1.5 billion people globally experience some degree of hearing loss, a figure projected to reach 2.5 billion by 2050.notebookcheck+2

Full support requires a compatible Galaxy device running One UI 8 or later.news.samsung