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Samsung Electronics has obtained medical device approval from the Ministry of Food and Drug Safety (MFDS) for the "Hearing Test" and "Hearing Aid" features to be included in Galaxy Buds. / Courtesy of Samsung Electronics

Samsung Electronics' Galaxy Buds have received medical device approval from the Ministry of Food and Drug Safety (MFDS) for their Hearing Test and Hearing Aid features.

On Nov. 4, Samsung Electronics announced that the Galaxy Buds4 Pro and Galaxy Buds3 Pro could be used for hearing testing and hearing assistance. The features are scheduled to become available through a software update early next year.

Specifically, users will be able to check their hearing test results directly using the Galaxy Buds' Hearing Test feature, which is registered as Software as a Medical Device (SaMD). The feature uses clinical-grade pure-tone air-conduction audiometry to measure each ear separately while the user wears the earbuds, determining the degree of hearing loss.

Pure-tone air-conduction audiometry is a standard testing method that plays individual tones at different frequencies and measures the lowest sound level a person can hear.

Test results are classified into seven levels: normal, minimal, mild, moderate, moderately severe, severe and profound hearing loss. Users can also receive guidance on necessary measures based on their results.

The Hearing Aid feature uses the Hearing Test results to amplify sounds that users have difficulty hearing, adjusting the amplification to their individual audiograms.

In particular, Galaxy Buds use NAL-NL2, a globally recognized clinical standard fitting formula. Developed by Australia's National Acoustic Laboratories (NAL), the hearing aid prescription formula is used to calculate optimal amplification levels at different frequencies based on an individual's audiogram. According to Samsung Electronics, this enables the feature to provide results tailored to each user's hearing characteristics.

Samsung Electronics has been developing hearing assistance technology since introducing a personal sound amplification feature in the Galaxy Buds+ in 2020. In 2021, the feature underwent clinical validation confirming its effectiveness in supporting everyday communication among users with hearing loss, laying the foundation for the new Hearing Aid feature.

The company had already obtained clearance from the U.S. Food and Drug Administration (FDA) for the same feature in July.

"With this approval from the Ministry of Food and Drug Safety, we have expanded access to hearing assistance by integrating the Hearing Test and Hearing Aid features directly into Galaxy Buds," said Hon Pak, head of the Digital Health Team at Samsung Electronics' Mobile eXperience (MX) Business.

"We will continue to expand personalized health management experiences based on the connectivity of the Galaxy ecosystem and digital health technologies," he added.

                                                                                                               Choi In-gyu