Samsung Electronics secured U.S. Food and Drug Administration clearance for a built-in hearing aid feature on its Galaxy Buds, allowing users 18 and older with perceived mild to moderate hearing loss to use the earbuds as over-the-counter devices without a prescription or clinic visit, according to a company announcement on Aug. 11, 2026. The authorization follows Apple’s model for AirPods Pro and expands consumer tech options, addressing a World Health Organization projection that over 1.5 billion people globally experience hearing loss.
FDA Clearance Brings OTC Hearing Aid Software to Galaxy Buds
The newly cleared software lets compatible Galaxy Buds function as an over-the-counter hearing aid for adults experiencing perceived mild to moderate hearing loss, according to Samsung Electronics. Users can bypass traditional clinic visits and prescriptions. Hon Pak, senior vice president and head of the digital health team for the Mobile eXperience (MX) Business at Samsung Electronics, said in a release that the clearance expands access to hearing support and makes proactive care effortless.
Five-Minute Self-Administered Hearing Test Powered by SaMD
The hearing health experience requires no separate app and is built directly into device settings, according to Samsung. Users navigate to the Galaxy Buds menu to complete a five-minute self-administered hearing test using clinical-grade, pure-tone audiometry. Registered as Software as a Medical Device, the test evaluates each ear individually to generate an audiogram with accuracy comparable to a professional audiologist’s evaluation, as stated by Samsung. Results categorize hearing as normal or place it into mild, moderate, severe, or profound stages of loss.
Pro Tip: Users can access hearing-related insights, including noise exposure levels and hearing test results, directly within the Samsung Health app, as noted in company specifications.
Clinical Validation and Professional Partnerships
Samsung’s path to the FDA milestone spans six years of audio development, starting with a Personal Sound Amplification Product feature on Galaxy Buds+ in 2020 that was clinically validated in 2021. To build the current OTC device, Samsung collaborated with the National Acoustic Laboratories and Samsung Medical Center. Validation studies took place at Vanderbilt University Medical Center, San Jose State University, and the University of Memphis, according to company documentation.
Global Market Context and Projected Availability
The World Health Organization estimates that global hearing loss will reach 2.5 billion people by 2050, up from more than 1.5 billion today. Samsung noted that many individuals who could benefit from amplification avoid devices due to cost, social stigma, or limited access to care. While specific pricing was not disclosed, Samsung targeted a fourth-quarter 2026 rollout for the United States, with features slated for models including Galaxy Buds3 Pro and Galaxy Buds4 Pro.
Did You Know?
Galaxy Buds use the NAL-NL2 formula—recognized globally as a clinical standard for prescription hearing aid fitting—alongside advanced noise elimination and beamforming capabilities, according to Samsung.
Frequently Asked Questions
Who is eligible to use the Samsung Galaxy Buds hearing aid feature?
The feature is cleared for users 18 years and older with perceived mild to moderate hearing loss, according to Samsung.
Do users need a prescription or a doctor’s visit?
No. The feature operates as an over-the-counter solution that does not require a prescription or a clinical visit, as stated by Samsung.
How long does the built-in hearing test take?
The self-administered test takes approximately five minutes and uses pure-tone audiometry, according to Samsung Electronics.
When and where will the feature be available?
Samsung targeted the fourth quarter of 2026 for availability in the United States on compatible models like Galaxy Buds3 Pro and Galaxy Buds4 Pro.
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