Samsung Galaxy Buds Win MFDS Approval for Hearing Test and Sound Amplification Features

Samsung Electronics announced on November 4 that the "Hearing Test" and "Hearing Care" features for its Galaxy Buds wireless earphones have gained medical device approval from South Korea's Ministry of Food and Drug Safety (MFDS). These features enable users of the Galaxy Buds4 Pro and Galaxy Buds3 Pro models to assess their hearing and adjust audio settings without needing extra equipment.

The approval allows users to check their hearing using pure-tone air-conduction audiometry, which evaluates the softest sounds each ear can detect at various frequencies. Results are categorized into seven levels, from normal to profound hearing loss, and displayed as an individual audiogram, along with recommendations for follow-up action.

This information can be saved to the Samsung Health app for monitoring changes over time. The "Hearing Care" feature utilizes the test outcomes to amplify sounds at frequencies where users struggle to hear, employing the NAL-NL2 formula, a hearing-aid prescription method developed by Australia's National Acoustic Laboratories. This adjustment is aimed at adults aged 18 and older who may have mild to moderate hearing loss.

Users can personalize sound settings based on their hearing profiles without needing the help of a hearing specialist. Samsung introduced the sound amplification feature in the Galaxy Buds Plus in 2020 and has since improved it through clinical testing. A 2021 study showed that the feature can aid communication for individuals with hearing loss in daily life.

Samsung Electronics' Digital Health Team reported a significant surge in third-quarter revenue and operating profit, with the medical device software approval furthering the company's strategy to diversify into digital healthcare solutions.