Samsung Electronics has secured medical device clearance from the United States Food and Drug Administration (FDA) for its Galaxy Buds Hearing Aid feature. The clearance allows adults aged 18 and older with perceived mild to moderate hearing loss to use compatible Galaxy Buds as over-the-counter (OTC) hearing aids without visiting a doctor or obtaining a prescription. Alongside the hearing aid functionality, Samsung introduced a self-administered Hearing Test feature registered as Software as a Medical Device (SaMD). This feature gives users medical-grade audiogram assessments directly from their smartphone settings.
Key Takeaways
- Galaxy Buds receive FDA clearance to operate as non-prescription OTC hearing aids for users 18 and older.
- The integrated five-minute Hearing Test uses pure-tone audiometry to generate personalized audiograms.
- Samsung uses the NAL-NL2 clinical fitting formula alongside noise reduction and beamforming controls.
- The features will roll out to Galaxy Buds3 Pro and Galaxy Buds4 Pro in the US and select markets starting in Q4 2026.
How the Hearing Test and Hearing Aid Features Function
The built-in software allows users to manage their auditory health without downloading extra third-party apps. Users can access the tool under the standard Galaxy Buds settings menu. The self-test runs for five minutes, delivering pure-tone audiometry to evaluate each ear independently. The test classifies auditory response into normal, mild, moderate, severe, or profound loss.
Once testing finishes, the system creates an audiogram and calibrates the audio output based on the NAL-NL2 fitting formula, an internationally recognized standard in audiology. The earbuds target difficult frequency ranges, whispers, and distant sounds to provide clear sound.
Users can also customize controls in the software:
- Separate or unified volume sliders for each ear.
- Sound direction adjustment between ambient all-around listening and focused front-facing reception.
- Adjustable background noise reduction levels.
- Audiogram data sync directly with the Samsung Health application.
Clinical Background and Market Rollout
According to World Health Organization estimates, over 1.5 billion people live with some form of hearing loss globally. Samsung began early work in consumer hearing assistance in 2020 by adding a Personal Sound Amplification Product (PSAP) tool to Galaxy Buds+.
To build the newly cleared OTC solution, Samsung partnered with the National Acoustic Laboratories (NAL) and Samsung Medical Center (SMC). Academic partners at Vanderbilt University Medical Center, San Jose State University, and the University of Memphis provided validation research.
Samsung will release the software update for Galaxy Buds3 Pro and Galaxy Buds4 Pro users in the United States and select approved regions in the fourth quarter of 2026.
Frequently Asked Questions
Q1. Which Galaxy Buds models support the FDA-cleared hearing aid feature?
A1. The Hearing Aid and Hearing Test tools will be available on the Galaxy Buds3 Pro and Galaxy Buds4 Pro.
Q2. Do users need a doctor prescription to use this feature?
A2. No, the FDA cleared it as an over-the-counter feature for adults 18 and older with perceived mild to moderate hearing loss.
Q3. When will the hearing aid update be released?
A3. Samsung plans to launch the feature in Q4 2026 in the United States and select approved international markets.
