FDA Approval for Hearing Aid Functionality in Samsung Galaxy Buds Marks Industry Milestone

Samsung Electronics has achieved a significant milestone by obtaining U.S. Food and Drug Administration (FDA) clearance for its Galaxy Buds Hearing Aid feature. Designed to function as an over-the-counter (OTC) hearing aid, this feature provides adults over 18 with a non-prescription solution for perceived mild to moderate hearing loss. The device aims to enhance auditory experiences in environments where following conversations can be challenging, without necessitating a clinic visit.

The Galaxy Buds also include a Hearing Test feature, certified as a Software as a Medical Device (SaMD), offering users the ability to self-diagnose their hearing capabilities with results comparable to medical-grade assessments.

Addressing a Global Health Concern

Hon Pak, Senior Vice President and Head of the Digital Health Team for Samsung’s Mobile eXperience (MX) Business, emphasized the importance of hearing health, stating, “The FDA’s clearance allows us to expand hearing support access, simplifying proactive care by integrating Hearing Test and Hearing Aid functionalities directly into the Galaxy Buds.”

Hearing impairment is a pervasive issue, with the World Health Organization (WHO) estimating over 1.5 billion people globally suffer some form of hearing loss—a number expected to rise to 2.5 billion by 2050. The prohibitive cost, societal stigma, and limited access to professional care often deter individuals from using conventional hearing aids.

Technological Advancements

Samsung’s commitment to advancing hearing aid technology began in 2020 with the introduction of a Personal Sound Amplification Product (PSAP) in Galaxy Buds+. Clinically validated in 2021, this feature laid the groundwork for the new Hearing Aid capability. Collaboration with the National Acoustic Laboratories (NAL) and Samsung Medical Center (SMC) facilitated the development of this OTC solution, supported by clinical validation from institutions such as Vanderbilt University Medical Center and San Jose State University.

The Galaxy Buds Hearing Aid feature capitalizes on two main components integrated directly into the device:

• A self-administered Hearing Test, which uses clinical-grade pure-tone audiometry to assess each ear separately, generating a detailed audiogram.
• A Hearing Aid feature that customizes sound amplification based on the user’s specific hearing profile, employing NAL-NL2, a globally recognized fitting formula for prescription hearing aids.

These features include advanced options like noise elimination and beamforming to enhance sound clarity and reduce background interference.

Market Availability

The Galaxy Buds Hearing Aid and Hearing Test features are slated for release on the Galaxy Buds3 Pro and Galaxy Buds4 Pro in the U.S. and select markets by Q4 2026. These capabilities are exclusive to users 18 and older with perceived mild to moderate hearing loss and require a compatible Galaxy device with One UI 8 or later. Hearing-related insights and test results will be integrated within the Samsung Health app, providing a holistic view of user wellness.