Samsung’s Hearing Aid Feature on Galaxy Buds Cleared by FDA

Samsung Electronics Co., Ltd. today announced that its Galaxy Buds Hearing Aid feature has received U.S. Food and Drug Administration (FDA) clearance. The feature enables compatible Galaxy Buds¹ to serve as an over-the-counter (OTC) hearing aid,² offering users over the age of 18 a convenient solution for addressing perceived mild to moderate hearing loss — which may be indicated by difficulty following conversations in noisy environments — without a prescription or clinic visit. Users can also diagnose their hearing with the Galaxy Buds Hearing Test feature (available on Galaxy Buds3 Pro and Galaxy Buds4 Pro), which is registered as a Software as a Medical Device (SaMD) and provides medical-grade results.

“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, Senior Vice President and Head of the Digital Health Team for the Mobile eXperience (MX) Business at Samsung Electronics. “With the latest clearance from the FDA, we are expanding access to hearing support and making proactive care effortless by integrating Hearing Test and Hearing Aid functionality directly into the Galaxy Buds.”

Hearing loss is incredibly common, yet it remains one of the most overlooked health conditions worldwide. The World Health Organization (WHO) estimates that globally, more than 1.5 billion people experience some degree of hearing loss — a figure projected to reach 2.5 billion people by 2050. Despite this, many people who could benefit from hearing aids do not use them due to high cost, social stigma, or limited access to professional care.

Samsung is committed to advancing hearing support technologies for consumers. In 2020, the company introduced a Personal Sound Amplification (PSAP) feature on Galaxy Buds+. The PSAP feature was clinically validated in 2021 as effective support for daily communication for those with hearing loss, building the foundation for the Hearing Aid feature. 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.

Samsung’s holistic hearing health experience centers around two major features integrated directly into Galaxy Buds without requiring a separate app.³ By navigating to the Galaxy Buds menu in Settings, users can complete a self-administered Hearing Test in just five minutes. Using clinical-grade, pure-tone audiometry, the software tests each ear individually to pinpoint the user’s specific hearing deficits. It then generates an audiogram with accuracy comparable to a professional audiologist’s evaluation. The results categorize the user’s hearing as normal or one of four stages of hearing loss: mild, moderate, severe, or profound.

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. 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.

Galaxy Buds use NAL-NL2, recognized globally as the clinical standard formula for fitting prescription hearing aids. This advanced approach ensures highly personalized, accurate results tailored to each individual’s hearing profile.

To give users a comprehensive view of their overall wellness, hearing-related insights — including noise exposure levels and Hearing Test results — are accessible directly within the Samsung Health app.

Availability

The Hearing Aid and Hearing Test features will be available on Galaxy Buds3 Pro and Galaxy Buds4 Pro in the U.S. and select approved markets in Q4, 2026.

1 Available on Galaxy Buds3 Pro and Galaxy Buds4 Pro only.

2 Availability may vary by market, model or paired device. The Hearing Aid feature is intended for users 18 years and older with perceived mild to moderate hearing loss and is not a substitute for professional diagnosis or treatment by a qualified clinician.

3 Full support requires a compatible Galaxy device with One UI 8 or later.