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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Masker, Tinnitus
510(k) Number K260614
Device Name Tinnitus Therapy
Applicant
Sivantos GmbH
Henri-Dunant-Str. 100
Erlangen,  DE 91058
Applicant Contact Anja Ravn
Correspondent
Sivantos GmbH
Henri-Dunant-Str. 100
Erlangen,  DE 91058
Correspondent Contact Anja Ravn
Regulation Number874.3400
Classification Product Code
KLW  
Date Received02/25/2026
Decision Date 06/10/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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