{"@context":"https://neupai.io/schema/v0.2","@type":"StructuredNewsArticle","identity":{"article_id":"samsung-newsroom_20261104_galaxy-buds-hearing-test","canonical_url":"https://news.samsung.com/kr/%EC%82%BC%EC%84%B1%EC%9E%90-%EA%B0%A4%EB%9F%AD%EC%8B%9C-%EB%B2%84%EC%88%80-%EC%B2%AD%EB%A0%A5-%EC%B2%B4%ED%81%AC-%EF%82%9E-%EC%B2%AD%EB%A0%A5-%EC%BC%80%EC%96%B4-%EA%B8%B0%EB%B0%8C","ai_url":null,"publisher":{"name":"삼성전자 뉴스룸","domain":"https://news.samsung.com/kr/","type":"online"},"author":"삼성전자 뉴스룸","published_at":"2026-11-04T08:00:00.000Z","updated_at":null,"language":"en","article_type":"straight_news","originality":"self_produced"},"content":{"headline":"Samsung Electronics Obtains MFDS Approval for Galaxy Buds' 'Hearing Check' and 'Hearing Care' Features","summary":"Samsung Electronics has obtained medical device approval from the Ministry of Food and Drug Safety (MFDS) for the 'Hearing Check' and 'Hearing Care' features on its Galaxy Buds. The features will be rolled out sequentially to Galaxy Buds4 Pro and Galaxy Buds3 Pro users via a software update in early 2027.","topics":["economy","technology"],"geography":["KR"],"entities":[{"name":"Samsung Electronics","canonical_id":"corp:kr:samsung-electronics","type":"company","role_in_article":"primary_subject","metadata":{"ticker":null,"parent":null}},{"name":"Galaxy Buds","canonical_id":"product:kr:galaxy-buds","type":"product","role_in_article":"primary_subject","metadata":{"ticker":null,"parent":null}},{"name":"Ministry of Food and Drug Safety (MFDS)","canonical_id":"org:kr:fda","type":"organization","role_in_article":"source","metadata":{"ticker":null,"parent":null}},{"name":"FDA","canonical_id":"org:us:fda","type":"organization","role_in_article":"source","metadata":{"ticker":null,"parent":null}},{"name":"Park Heon-soo","canonical_id":"person:kr:samsung-electronics","type":"person","role_in_article":"quoted","metadata":{"ticker":null,"parent":null}}],"claims":[{"id":"c1","statement":"Samsung Electronics obtained medical device approval from the Ministry of Food and Drug Safety (MFDS) for the 'Hearing Check' and 'Hearing Care' features on Galaxy Buds.","as_of":"2026","as_of_explicit":false,"as_of_raw":"2026","source_type":"company_plan","comparison":null,"type":"future_plan","figures":{"value":0,"unit":"","approximate":false,"converted":null},"expiry_hint":null,"insight":null},{"id":"c2","statement":"Starting in early 2027, Galaxy Buds4 Pro and Galaxy Buds3 Pro users will be able to use their existing Galaxy Buds for 'Hearing Check' and 'Hearing Care' purposes.","as_of":"2026-11","as_of_explicit":true,"as_of_raw":"early 2027","source_type":"company_plan","comparison":null,"type":"future_plan","figures":{"value":0,"unit":"","approximate":false,"converted":null},"expiry_hint":null,"insight":null},{"id":"c3","statement":"The 'Hearing Check' and 'Hearing Care' features of the Galaxy Buds will be provided sequentially through a software update.","as_of":"2026-11","as_of_explicit":false,"as_of_raw":"November 2026","source_type":"media_report","comparison":null,"type":"fact","figures":{"value":0,"unit":"","approximate":false,"converted":null},"expiry_hint":null,"insight":null},{"id":"c4","statement":"'Hearing Check' measures each ear individually to assess the degree of hearing loss and generates an audiogram.","as_of":"2026-11","as_of_explicit":false,"as_of_raw":"November 2026","source_type":"media_report","comparison":null,"type":"fact","figures":{"value":0,"unit":"","approximate":false,"converted":null},"expiry_hint":null,"insight":null},{"id":"c5","statement":"Hearing test results are classified into seven levels: normal, slight, mild, moderate, moderately severe, severe, and profound.","as_of":"2026-11","as_of_explicit":false,"as_of_raw":"November 2026","source_type":"media_report","comparison":null,"type":"fact","figures":{"value":7,"unit":"levels","approximate":false,"converted":null},"expiry_hint":null,"insight":null},{"id":"c6","statement":"The 'Hearing Care' feature amplifies sounds that users have difficulty hearing based on their audiogram.","as_of":"2026-11","as_of_explicit":false,"as_of_raw":"November 2026","source_type":"media_report","comparison":null,"type":"fact","figures":{"value":0,"unit":"","approximate":false,"converted":null},"expiry_hint":null,"insight":null},{"id":"c7","statement":"Users aged 18 or older suspected of having mild to moderate hearing loss can adjust the Galaxy Buds' sound using this feature without the help of a hearing specialist.","as_of":"2026-11","as_of_explicit":false,"as_of_raw":"November 2026","source_type":"media_report","comparison":null,"type":"fact","figures":{"value":18,"unit":"years","approximate":false,"converted":null},"expiry_hint":null,"insight":null},{"id":"c8","statement":"The Galaxy Buds apply 'NAL-NL2,' a globally recognized clinical standard formula, to provide results tailored to individual hearing characteristics.","as_of":"2026-11","as_of_explicit":false,"as_of_raw":"November 2026","source_type":"media_report","comparison":null,"type":"fact","figures":{"value":0,"unit":"","approximate":false,"converted":null},"expiry_hint":null,"insight":null},{"id":"c9","statement":"Development and clinical validation of hearing support technology has been ongoing since 2020.","as_of":"2026-11","as_of_explicit":false,"as_of_raw":"November 2026","source_type":"media_report","comparison":null,"type":"fact","figures":{"value":0,"unit":"","approximate":false,"converted":null},"expiry_hint":null,"insight":null},{"id":"c10","statement":"In 2021, the feature underwent clinical validation confirming its effectiveness for daily communication among users with hearing loss.","as_of":"2026-11","as_of_explicit":true,"as_of_raw":"2021","source_type":"media_report","comparison":null,"type":"fact","figures":{"value":0,"unit":"","approximate":false,"converted":null},"expiry_hint":null,"insight":null},{"id":"c11","statement":"The U.S. Food and Drug Administration (FDA) approved the same feature last July.","as_of":"2026-07","as_of_explicit":true,"as_of_raw":"last July","source_type":"company_plan","comparison":null,"type":"fact","figures":{"value":0,"unit":"","approximate":false,"converted":null},"expiry_hint":null,"insight":null},{"id":"c12","statement":"Park Heon-soo, Vice President and Head of the Digital Health Team at Samsung Electronics' MX Business, said that MFDS approval has expanded accessibility to hearing support by directly integrating the 'Hearing Check' and 'Hearing Care' features into Galaxy Buds.","as_of":"2026-11","as_of_explicit":false,"as_of_raw":"November 2026","source_type":"media_report","comparison":null,"type":"opinion","figures":{"value":0,"unit":"","approximate":false,"converted":null},"expiry_hint":null,"insight":null}],"image":{"url":"https://onjblseywainslkhvkav.supabase.co/storage/v1/object/public/article-images/f7fd49c7-a3d8-44c6-9cb7-1e6e29fcb41f.jpg","alt":"갤럭시 버즈 앱의 청력 검사 결과, 보청기 기능 설정, 오디오그램 화면을 보여주는 스마트폰 UI 3컷.","caption":"▲ 삼성전자가 갤럭시 버즈에 탑재될 ‘청력 체크(Hearing Test)’와 ‘청력 케어(Hearing Aid)’ 기능으로 식품의약품안전처(이하 식약처)의 의료기기 허가를 획득했다","source":"first_img","alt_status":"auto"}},"provenance":{"source_chain":["primary_reporting"],"original_source_url":null,"related_articles":[]},"temporal":{"freshness":"recent","next_update_expected":null},"access":{"license":"neupai_standard","attribution_required":true,"structured_data":"free","full_text_available":false,"full_text_access":null}}