Samsung's Galaxy Buds get green light for hearing aid functions
Quick Look
- Samsung Electronics has received Korean medical-device approval for Hearing Test and Hearing Aid functions on Galaxy Buds4 Pro and Buds3 Pro, launching early next year via software updates.
- The features use pure-tone audiometry and the NAL-NL2 formula to support users aged 18+ with suspected mild to moderate hearing loss, following US FDA clearance in July.
AI-generated summary
Why It Matters
Samsung introduced personal sound amplification product technology in the Galaxy Buds Plus in 2020 and conducted clinical validation in 2021 to assess its effectiveness in supporting daily communication for people with hearing loss. The company received US Food and Drug Administration clearance for the same features in July.
Samsung Electronics has secured Korean medical-device approval from the Ministry of Food and Drug Safety for the "Hearing Test" and "Hearing Aid" functions on its Galaxy Buds4 Pro and Buds3 Pro.
The features are set to launch early next year through software updates, bringing Samsung into closer competition with Apple's AirPods.
The Hearing Test feature uses pure-tone air-conduction audiometry to measure hearing in each ear and generate an audiogram. Results are classified into seven levels, from normal to profound hearing loss, with guidance on follow-up measures.
The Hearing Aid function adjusts sound amplification based on individual hearing profiles. Users aged 18 or older with suspected mild to moderate hearing loss can customize audio settings without assistance from a hearing specialist. It uses the NAL-NL2 formula, developed by Australia's National Acoustic Laboratories, to calculate amplification levels for different frequencies.
Users can also check hearing test results and noise exposure levels through the Samsung Health app.
Samsung introduced personal sound amplification product technology in the Galaxy Buds Plus in 2020 and conducted clinical validation in 2021 to assess its effectiveness in supporting daily communication for people with hearing loss. The company received US Food and Drug Administration clearance for the same features in July.
"We have integrated hearing test and hearing aid functions into Galaxy Buds, making hearing support more accessible," said Pak Hon-soo, senior vice president of the Digital Health Team at Samsung Electronics' Mobile eXperience business. "We will continue to expand personalized health management services through our Galaxy ecosystem and digital health technologies."
The US Food and Drug Administration approved the same functions in July, with plans to launch in the fourth quarter.
What to Watch
AI outlook — possibilities, not facts
Samsung will roll out the Hearing Test and Hearing Aid features via software update early next year.
Very likely · Within months
Open Questions
- Which specific markets outside Korea and the US will receive the hearing features?
- What is the exact launch date for the software update?
- Will the hearing features require a subscription or additional hardware?


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