Samsung has received U.S. Food and Drug Administration clearance for its Galaxy Buds Hearing Aid feature, enabling compatible earbuds to function as over-the-counter hearing aids for adults aged 18 and older with perceived mild to moderate hearing loss.
The functionality will be available on Galaxy Buds3 Pro and Galaxy Buds4 Pro, alongside Samsung’s Galaxy Buds Hearing Test feature. The self-administered test takes approximately five minutes and uses clinical-grade, pure-tone audiometry to assess each ear individually and identify hearing deficits.
Samsung said the resulting assessment is comparable to an evaluation conducted by a professional audiologist, categorizing hearing loss as normal, mild, moderate, severe or profound. The Hearing Aid feature subsequently uses these results to personalize and adjust sound for the individual user.
The technology also incorporates noise elimination and beamforming. The latter uses multiple microphones to focus on sound originating in front of the wearer while reducing background noise from the side or rear.
Both the Hearing Aid and Hearing Test features are scheduled to become available to U.S. customers using Galaxy Buds3 Pro and Galaxy Buds4 Pro in the fourth quarter of 2026.
"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 Samsung Electronics’ Mobile eXperience business.
The clearance follows regulatory changes that have expanded access to consumer hearing technology. In 2022, the FDA established a category of over-the-counter hearing aids, allowing adults with perceived mild to moderate hearing loss to purchase eligible products without a prescription.
Apple subsequently received FDA authorization through the De Novo pathway in September 2024 for hearing aid software embedded in AirPods Pro 2. The software enabled the earbuds to operate as hearing aids and used machine learning to adjust sound according to users’ hearing requirements.
Apple later expanded its hearing-health capabilities internationally and has incorporated Hearing Test, Hearing Aid and Hearing Protection functionality into AirPods Pro 3. Samsung’s clearance further extends hearing-assistance functionality into widely used consumer earbuds.
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