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

    Intrisound™ Tuned Lumen® 155 Hearing Aids

    K Number: K223848 · Decision Sep 8, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    8
    Applicant Total
    2
    Review Days
    260

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    Basic Information

    Device Name
    Intrisound™ Tuned Lumen® 155 Hearing Aids
    K Number
    K223848
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3325
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tuned , Ltd.
    Date Received
    December 22, 2022
    Decision Date
    September 8, 2023
    Product Code
    QUH
    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
    QUH Self-Fitting Air-Conduction Hearing Aid, Over The Counter

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    Other Clearances by Tuned , Ltd.

    K Number Device Name
    K251208 Tuned Self-Fitting Mobile App