BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    Tuned Self-Fitting Mobile App

    K Number: K251208 · Decision Sep 26, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    2
    Applicant Total
    2
    Review Days
    161

    Basic Information

    Device Name
    Tuned Self-Fitting Mobile App
    K Number
    K251208
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3335
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tuned , Ltd.
    Date Received
    April 18, 2025
    Decision Date
    September 26, 2025
    Product Code
    SCR
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    SCR Air-Conduction Hearing Aid Software

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    Other Clearances by Tuned , Ltd.

    K Number Device Name
    K223848 Intrisound™ Tuned Lumen® 155 Hearing Aids