IBNS-CMEDIA: Samsung Electronics has announced that its Galaxy Buds Hearing Aid feature has received clearance from the U.S. Food and Drug Administration (FDA), allowing compatible Galaxy Buds to function as over-the-counter (OTC) hearing aids for eligible users.
The feature is designed for people aged 18 and above experiencing perceived mild to moderate hearing loss. It aims to provide a convenient way to address hearing difficulties, such as struggling to follow conversations in noisy environments, without requiring a prescription or a clinic visit.
Users can also assess their hearing through Samsung’s Galaxy Buds Hearing Test feature, which is registered as 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 at Samsung Electronics’ Mobile eXperience (MX) Business.
“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,” he added.
Galaxy Buds to Offer Personalised Hearing Support
Hearing loss is one of the most common health conditions worldwide. The World Health Organization (WHO) estimates that more than 1.5 billion people globally experience some degree of hearing loss, with that number projected to rise to 2.5 billion by 2050.
Despite its prevalence, many people who could benefit from hearing aids do not use them due to factors including cost, social stigma and limited access to professional care.
Samsung has been developing hearing-support technologies since 2020, when it introduced a Personal Sound Amplification Product (PSAP) feature on the Galaxy Buds+.
The PSAP feature was clinically validated in 2021 as providing effective support for daily communication among people with hearing loss, helping lay the groundwork for Samsung’s Hearing Aid feature.
For the new OTC solution, Samsung collaborated with the National Acoustic Laboratories (NAL) and Samsung Medical Center (SMC). The technology has also undergone clinical validation studies at Vanderbilt University Medical Center, San Jose State University and the University of Memphis.
Hearing Test Can Be Completed in Five Minutes
Samsung’s hearing-health experience combines two key features directly within compatible Galaxy Buds, eliminating the need for a separate app.
Users can access the Hearing Test through the Galaxy Buds menu in their device settings and complete a self-administered assessment in around five minutes.
Using clinical-grade pure-tone audiometry, the software tests each ear separately to identify specific hearing difficulties. It then generates an audiogram designed to provide results comparable in accuracy to a professional audiological evaluation.
The results classify hearing as normal or into one of four levels of hearing loss: mild, moderate, severe or profound.
Based on the test results, the Hearing Aid feature automatically adjusts sound amplification according to the user’s individual hearing profile. It can enhance sounds that may be difficult to hear, including higher-frequency sounds, surrounding whispers and distant voices.
The feature also includes advanced capabilities commonly associated with premium hearing aids, such as noise reduction and beamforming, which can help focus on sounds coming from in front of the user while reducing background noise.
Uses NAL-NL2 Hearing-Aid Fitting Formula
Galaxy Buds use NAL-NL2, a globally recognised clinical formula for fitting hearing aids. Samsung says the approach enables personalised adjustments based on each user’s hearing profile.
Hearing-related information, including noise exposure levels and Hearing Test results, can also be accessed through the Samsung Health app, giving users a broader view of their hearing and overall wellness.
Availability
The Hearing Aid and Hearing Test features will be available on Galaxy Buds3 Pro and Galaxy Buds4 Pro in the United States and select approved markets in Q4 2026.
