Back in the summer, Samsung’s Hearing Aid feature for the Galaxy Buds got cleared by the FDA in the US. Today, the company announced that its Hearing Test and Hearing Aid features have also received medical device approval in South Korea, from the country’s Ministry of Food and Drug Safety (MFDS).
Both features are coming to the Galaxy Buds4 Pro and Galaxy Buds3 Pro through a software update, with the rollout in Korea set to start in early 2027. Samsung hasn’t said when owners in the US will get them, even though the FDA clearance came first.
The Hearing Test is based on clinical-grade pure-tone air conduction audiometry, which plays single tones at different frequencies to find the quietest sound you can hear, and it measures each ear separately. You then get an audiogram that puts your hearing into one of seven levels (normal, slight, mild, moderate, moderately severe, severe, and profound), along with guidance on what to do next.
The Hearing Aid feature uses that audiogram to amplify only the sounds you struggle to hear. It relies on NAL-NL2, a prescription formula developed by Australia’s National Acoustic Laboratories that’s widely used for hearing aids. It’s meant for adults aged 18 and over who suspect they have mild to moderate hearing loss, and they can tune it to their needs without help from a hearing specialist. Insights like your noise exposure levels and test results also show up in the Samsung Health app.
This has been a long time coming – Samsung first added a personal sound amplification feature to the Galaxy Buds+ back in 2020, and clinical testing in 2021 found it helped people with hearing loss in everyday conversations. Samsung’s Park Heon-soo, head of the Digital Health team in its MX business, says building both features right into the Galaxy Buds broadens access to hearing support.
Source (in Korean)