Samsung Electronics announced that it has received medical device approval from the Ministry of Food and Drug Safety for the 'Hearing Check' and 'Hearing Care' features to be integrated into the Galaxy Buds.
With this approval, users of the Galaxy Buds4 Pro and Galaxy Buds3 Pro will be able to utilize their existing Galaxy Buds for 'Hearing Check' and 'Hearing Care' purposes.
The 'Hearing Check' and 'Hearing Care' features will be gradually rolled out through software updates for domestic Galaxy Buds4 Pro and Galaxy Buds3 Pro users starting early next year.
Users can directly check their hearing test results using the 'Hearing Check' feature, which is registered as digital medical device software.
The 'Hearing Check' can be conducted through the Galaxy Buds menu in smartphone settings.
Using a clinical-level pure tone air conduction hearing test method, the device measures each ear of the user wearing the Buds to assess the degree of hearing loss and generates an audiogram based on the results.
The test results are classified into seven levels: normal, mild, moderate, moderately severe, severe, and profound, allowing users to see their results along with guidance on necessary follow-up actions.
The 'Hearing Care' feature amplifies sounds that the user struggles to hear based on the results from the 'Hearing Check,' allowing users aged 18 and older who suspect mild to moderate hearing loss to adjust the sound of the Galaxy Buds according to their hearing needs without the assistance of an audiologist.
Notably, the Galaxy Buds apply the globally recognized clinical standard 'NAL-NL2' to provide results tailored to individual hearing characteristics.
Samsung Electronics has been developing hearing support technology since introducing personal sound amplification products (PSAP) in the Galaxy Buds Plus in 2020.
In 2021, this feature underwent clinical validation, proving effective for daily communication among users with hearing loss, laying the groundwork for the current 'Hearing Care' feature.
The U.S. Food and Drug Administration (FDA) granted approval for the same features in July.
Park Heon-soo, Vice President and Head of the Digital Health Team at Samsung Electronics' MX Division, stated, "With this approval from the Ministry of Food and Drug Safety, we have integrated the 'Hearing Check' and 'Hearing Care' features directly into the Galaxy Buds, broadening accessibility to hearing support. Samsung Electronics will continue to expand proactive and personalized health management experiences based on the connectivity of the Galaxy ecosystem and digital health technology."
* This article has been translated by AI.
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