Galaxy Buds4 Pro and Buds3 Pro Win Korean Approval as Hearing Aids
Samsung’s Galaxy Buds are about to do a second job. South Korea’s Ministry of Food and Drug Safety has approved the Galaxy Buds Hearing Check and Hearing Care features as medical device software, so the Galaxy Buds4 Pro and the Galaxy Buds3 Pro will be able to test their owner’s hearing and amplify the sounds that owner misses — without a separate hearing aid. The features roll out in South Korea gradually through software updates starting in early 2027.
At a glance
Korean approval: 4 November 2026, Ministry of Food and Drug Safety — CONFIRMED
Models: Galaxy Buds4 Pro and Galaxy Buds3 Pro only — CONFIRMED
Korea rollout: Gradual software updates from early 2027 — CONFIRMED
US clearance: FDA clearance announced August 2026 — CONFIRMED
US rollout: US and select markets in Q4 2026, per Samsung’s August announcement — CONFIRMED
How it works
The two features are complementary. Hearing Check plays single tones at different frequencies into each ear and measures the faintest sound the wearer can detect, using clinical-grade pure-tone air conduction audiometry. Hearing Care then uses those results to amplify the frequencies the wearer struggles with, tuned to the NAL-NL2 formula — the prescription standard developed by Australia’s National Acoustic Laboratories and used in hearing-aid fitting worldwide. Results and noise-exposure levels are visible in the Samsung Health app.
The feature is intended for users aged 18 and older with perceived mild to moderate hearing loss — difficulty following conversations in noisy rooms, for example. It is not a substitute for a professional diagnosis or treatment by a qualified clinician, and Samsung says so in its own announcement. Full functionality requires a compatible Galaxy phone running One UI 9 or later.
Two approvals, two timelines
The Korean approval follows the United States Food and Drug Administration’s clearance, which Samsung announced in August. The August announcement put the United States and select approved markets in the fourth quarter of 2026; the November Korean announcement puts South Korea in early 2027. The two dates are not a contradiction — they are two regulators on two schedules — but they mean Korean owners wait longer than American ones for the same software.
Samsung’s hearing features arrive as Apple ships a similar capability on AirPods, and the comparison is fair: both turn earbuds many people already own into over-the-counter hearing support. The difference is the route — Samsung needed a medical-device approval in each market, and Korea has now granted its own.
Featured image: Galaxy Buds4 Pro — Image: Samsung. Sources: Samsung Electronics (announcement, 4 November 2026, via TheElec and SamMobile); Samsung Newsroom India (FDA clearance, 12 August 2026); Digital Trends (One UI 9 requirement, 5 November 2026).
