Samsung Electronics receives medical device approval for Galaxy Buds hearing features

Samsung Electronics Galaxy Buds hearing aid medical device approval digital health

Samsung Electronics has obtained medical device approval from South Korea’s Ministry of Food and Drug Safety for its Galaxy Buds “Hearing Test” and “Hearing Aid” functions. These features will be rolled out via software updates to Galaxy Buds4 Pro and Buds3 Pro users starting in early 2025.

The Hearing Test utilizes pure tone air conduction, a clinical standard, to measure hearing thresholds across different frequencies and generate an audiogram. Results are categorized into seven stages, ranging from normal to profound hearing loss. The Hearing Aid function uses these results to amplify specific frequencies that a user may struggle to hear, applying the NAL-NL2 prescription formula developed by the National Acoustic Laboratories in Australia.

Designed for adults aged 18 and older with mild to moderate hearing loss, the feature allows users to adjust sound settings without professional assistance. Hearing data and noise exposure insights can be managed through the Samsung Health app. This development follows Samsung’s previous FDA approval for similar functions in the United States.

Entities

Galaxy Buds · Ministry of Food and Drug Safety · National Acoustic Laboratories · Samsung Electronics · U.S. Food and Drug Administration

Claims

What the coverage asserts, and how many sources carry each claim.

[● 3 SOURCES] The Hearing Test uses the pure tone air conduction method to measure hearing thresholds and generate an audiogram. socialvalue.kr · www.techholic.co.kr · www.joseilbo.com
[● 3 SOURCES] Samsung Electronics previously obtained FDA approval for these functions in July. socialvalue.kr · www.techholic.co.kr · www.joseilbo.com
[○ 1 SOURCE] In FDA clinical data, the median absolute difference in hearing thresholds between the hearing test and standard clinical tests was 3.75 dB. www.joseilbo.com
[● 3 SOURCES] The Hearing Aid function applies the NAL-NL2 prescription formula developed by the National Acoustic Laboratories. socialvalue.kr · www.techholic.co.kr · www.joseilbo.com
[○ 1 SOURCE] The FDA approved hearing aid software for AirPods in September 2024. www.joseilbo.com
[● 3 SOURCES] The hearing aid feature is designed for users aged 18 and older with mild to moderate hearing loss. socialvalue.kr · www.techholic.co.kr · www.joseilbo.com
[● 3 SOURCES] Samsung Electronics obtained medical device approval from the Ministry of Food and Drug Safety for Galaxy Buds hearing test and hearing aid functions. socialvalue.kr · www.techholic.co.kr · www.joseilbo.com
[● 3 SOURCES] The hearing features will be provided to Galaxy Buds4 Pro and Buds3 Pro users via software updates starting in early 2025. socialvalue.kr · www.techholic.co.kr · www.joseilbo.com