Samsung Electronics announced that its Galaxy Buds Hearing Aid feature has received clearance from the U.S. Food and Drug Administration (FDA), allowing compatible Galaxy Buds1 to function as over-the-counter (OTC) hearing aids2 for adults age 18 and older with perceived mild to moderate hearing loss.
The feature is designed for users who may have difficulty following conversations in noisy environments and can be used without a prescription or clinic visit. Samsung is also offering a Hearing Test feature on the Galaxy Buds3 Pro and Galaxy Buds4 Pro. The company says the hearing test 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 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 Test and Personalized Amplification
According to Samsung, the hearing health experience centers around two features integrated directly into Galaxy Buds without requiring a separate app.3 Users can access the Galaxy Buds menu in Settings and complete a self-administered Hearing Test in approximately five minutes.
Using pure-tone audiometry, the software tests each ear individually and generates an audiogram. Samsung says the results categorize the user’s hearing as normal or as mild, moderate, severe, or profound hearing loss.
Based on those results, the Hearing Aid feature is designed to amplify sounds the user has difficulty hearing and personalize amplification according to the individual hearing profile.
The feature also incorporates technologies commonly found in hearing aids, including noise reduction and beamforming to emphasize sounds from in front of the listener while reducing competing background noise.
Galaxy Buds use NAL-NL2, a widely used clinical fitting prescription for hearing aids. Samsung developed the OTC hearing solution in collaboration with the National Acoustic Laboratories (NAL) and Samsung Medical Center. According to the company, clinical validation studies were conducted at Vanderbilt University Medical Center, San Jose State University, and the University of Memphis.
Samsung Expands Hearing Health Features
Samsung has been adding hearing-related functionality to its earbuds for several years. In 2020, the company introduced a Personal Sound Amplification Product (PSAP) feature on Galaxy Buds+. Samsung says the PSAP feature was clinically validated in 2021 as a support tool for daily communication among people with hearing loss, helping establish the foundation for the new Hearing Aid feature.
Hearing-related information, including noise exposure levels and Hearing Test results, can also be viewed within the Samsung Health app.
The development comes as major consumer electronics manufacturers increasingly incorporate hearing assessment and amplification capabilities into mainstream earbuds and wearable devices, expanding the range of options available to adults with perceived mild to moderate hearing loss.
Availability
The Hearing Aid and Hearing Test features are expected to become available on the Galaxy Buds3 Pro and Galaxy Buds4 Pro in the United States and select approved markets in the fourth quarter of 2026.
Full support requires a compatible Galaxy device running One UI 8 or later.3 Samsung notes that availability may vary by market, model, or paired device. The company states that the new Hearing Aid feature is intended for adults age 18 and older with perceived mild to moderate hearing loss and is not a substitute for professional diagnosis or treatment by a qualified clinician.2
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.
Source: Samsung Electronics
