Samsung announced today that its Galaxy Buds Hearing Aid feature has received U.S. Food and Drug Administration (FDA) clearance. The software feature allows compatible Galaxy Buds to function as over-the-counter (OTC) hearing aids, providing adults aged 18 and older with a prescription-free solution for perceived mild to moderate hearing loss without requiring a clinical visit.
Alongside the hearing aid capabilities, Samsung introduced a Galaxy Buds Hearing Test feature, which is registered as a Software as a Medical Device (SaMD) to provide medical-grade diagnostics.
Addressing Global Hearing Loss Accessibility
According to estimates from the World Health Organization (WHO), over 1.5 billion people worldwide experience some degree of hearing loss—a number projected to grow to 2.5 billion by 2050.
Despite the prevalence of the condition, adoption of hearing aids remains limited globally due to factors including high device costs, social stigma, and limited access to clinical audiologists.
Samsung’s development of consumer-accessible hearing technology began in 2020 with the introduction of a Personal Sound Amplification (PSAP) feature on the Galaxy Buds+. Clinically validated in 2021 as an effective communication aid, the PSAP technology served as the foundation for the newly cleared OTC feature.
Clinical Validation and Technical Development
To develop the OTC Hearing Aid system, Samsung collaborated with several research and medical institutions, including the National Acoustic Laboratories (NAL) and Samsung Medical Center (SMC). The software was evaluated in clinical validation studies conducted at Vanderbilt University Medical Center, San Jose State University, and the University of Memphis.
The system incorporates two primary features accessed through the native Galaxy Buds menu within device settings:
1. Pure-Tone Audiometry Hearing Test
Users can perform a self-administered hearing test in approximately five minutes. The software utilizes pure-tone audiometry to test each ear independently, generating an audiogram designed to match the accuracy of professional evaluations. Results categorize hearing levels into one of five stages:
- Normal
- Mild hearing loss
- Moderate hearing loss
- Severe hearing loss
- Profound hearing loss
2. Personalized Sound Amplification
For users with identified needs, the software applies the NAL-NL2 fitting formula—a standard algorithm used in prescription hearing aids—to automatically amplify targeted frequencies.
The feature selectively boosts hard-to-hear sounds, such as high-frequency tones, quiet voices, and ambient whisper levels, while utilizing beamforming and noise-suppression algorithms to isolate target speech from background noise.
System Integration and Market Availability
Hearing metrics, including historical Hearing Test results and ambient noise exposure tracking, sync directly with the Samsung Health application for centralized data review.
Availability Timeline
The Hearing Aid and Hearing Test features are scheduled to launch in the United States and select approved international markets in the fourth quarter of 2026. The functionality will be supported on the Galaxy Buds3 Pro and Galaxy Buds4 Pro.
Regarding this, 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. 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.