Samsung Galaxy Buds Gain FDA Clearance as OTC Hearing Aids, Launching Q4 2026
August 11, 2026 — Samsung announced today that its Hearing Aid feature for Galaxy Buds has received clearance from the U.S. Food and Drug Administration (FDA), allowing compatible earbuds to function as over-the-counter (OTC) hearing aids for adults.
The new Hearing Aid and Hearing Test features will roll out in the United States and select markets in Q4 2026, supporting the Galaxy Buds 3 Pro and Galaxy Buds 4 Pro.
A Medical-Grade Solution in Your Ears
Designed for users aged 18 and older with mild to moderate hearing loss, the feature offers a prescription-free, clinic-free alternative to traditional hearing aids. Samsung's wireless earbuds can now serve as a convenient hearing assistance tool, directly addressing a global health issue that remains widely overlooked.
The built-in Hearing Test function is registered as Software as a Medical Device (SaMD), delivering medical-grade diagnostic results. Users can complete the test in approximately five minutes directly within the Galaxy Buds settings menu — no additional apps required.
Once the test is complete, the Hearing Aid feature automatically adjusts audio output based on the user's personal hearing profile. It amplifies sounds that are harder to hear, such as distant voices and high-frequency sounds, using the NAL-NL2 method commonly employed in professional hearing aid fitting.
The earbuds also leverage noise reduction and beamforming technology to minimize background noise and focus on sounds coming from in front of the user.
Backed by Clinical Research
Samsung developed the hearing technology in close collaboration with Australia's National Acoustic Laboratories and Samsung Medical Center. The solution also underwent rigorous clinical validation studies at Vanderbilt University Medical Center, San Jose State University, and the University of Memphis.
Tackling a Global Health Challenge
Hearing loss is one of the most prevalent yet underaddressed health conditions worldwide. The World Health Organization estimates that over 1.5 billion people currently live with some degree of hearing loss, a figure projected to rise to 2.5 billion by 2050.
Despite the widespread need, many who could benefit from hearing aids remain without them due to high costs, social stigma, and limited access to professional healthcare services. By integrating FDA-cleared hearing assistance directly into popular consumer earbuds, Samsung aims to lower the barrier to entry and normalize hearing support as an everyday feature.
Samsung has been gradually building toward this milestone. In 2020, the company introduced a sound-amplifying feature on the Galaxy Buds+, laying the groundwork for today's more advanced, medically certified solution.
The Samsung Galaxy Buds Hearing Aid and Hearing Test features are expected to arrive via firmware update in Q4 2026.
