Galaxy Buds’ “Hearing Care” Feature Approved as a Medical Device

[Financial News] Samsung Electronics has received MFDS medical-device approval for Galaxy Buds’ hearing-test and sound-amplification functions. The wireless earbuds will allow users to check their hearing and adjust the sound based on their test results.
Samsung Electronics said on the 4th that the “Hearing Test” and “Hearing Aid” features for Galaxy Buds had received MFDS approval.
The features are scheduled to roll out in stages to Galaxy Buds4 Pro and Galaxy Buds3 Pro through a software update starting in early 2027.
Hearing Test is available from the Galaxy Buds menu in smartphone settings. With the Buds in, users can test each ear separately, check the degree of hearing loss at different frequencies and generate an audiogram. It uses pure-tone air-conduction testing, which plays pure tones at different frequencies and measures the lowest sound level the user can hear.
The test results are classified into seven levels, from normal to profound. Users can also view guidance on any measures they may need to take.
Hearing Care amplifies sounds that users have difficulty hearing based on their test results. Users aged 18 or older who are suspected of having mild to moderate hearing loss can adjust the sound of their Buds to match their audiogram. Samsung Electronics said it has applied the NAL-NL2 hearing-aid prescription formula, which calculates the amount of amplification based on each individual’s hearing characteristics.
Information such as noise exposure levels and Hearing Test results can be viewed in the Samsung Health app.
Samsung Electronics has been developing hearing-support technology since introducing a personal sound amplification product (PSAP) feature in the Galaxy Buds Plus in 2020. In 2021, it conducted clinical validation showing that the feature was effective in the daily communication of users with hearing loss. The Hearing Care feature also received approval from the U.S. Food and Drug Administration (FDA) last July.
Park Heon-su, vice president and head of the Digital Health Team in Samsung Electronics’ MX Business Division, said, “By integrating Hearing Test and Hearing Care into Galaxy Buds, we have broadened access to hearing support,” adding, “We will expand personalized health-management experiences through the connectivity of the Galaxy ecosystem and digital health technologies.” 

[email protected] Yoon Hong-jip Reporter