BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Hearing, Active, Middle Ear, Totally Implanted

    PMA: P090018 · Supplement: S027 · Decision Sep 10, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    Implant, Hearing, Active, Middle Ear, Totally Implanted
    Trade Name
    ESTEEM
    PMA Number
    P090018
    Supplement Number
    S027
    Device Class
    FDA Class 3
    Product Code
    OAF
    Generic Name
    Implant, hearing, active, middle ear, totally implanted
    Medical Specialty
    Unknown
    Advisory Committee
    Ear, Nose, Throat
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    September 10, 2014
    Date Received
    June 12, 2014
    Supplement Type
    Real-Time Process
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CHANGES TO CAPACITANCE SPECIFICATIONS FOR THE ESTEEM SENSOR AND DRIVER COMPONENTS, AND THE ESTEEM SYSTEM IS INTENDED TO ALLEVIATE HEARING LOSS INPATIENTS BY REPLICATING THE OSSICULAR CHAIN AND PROVIDING ADDITIONAL GAIN. THE ESTEEM IS INDICATED FOR PATIENTS WITH HEARING LOSS THAT MEET THE FOLLOWING CRITERIA:1) 18 YEARS OF AGE OR OLDER; 2) STABLE BILATERAL SENSORINEURAL HEARING LOSS;3) MODERATE TO SEVERE SENSORINEURAL HEARING LOSS DEFINED BY PURE TONE AVERAGE (PTA);4) UNAIDED SPEECH DISCRIMINATION TEST SCORE GREATER THAN OR EQUAL TO 40%;5) NORMALLY FUNCTIONING EUSTACHIAN TUBE6) NORMAL MIDDLE EAR ANATOMY;7) NORMAL TYMPANIC MEMBRANE;8) ADEQUATE SPACE FOR ESTEEM IMPLANT DETERMINED VIA A HIGH RESOLUTION CT SCAN; AND 9) MINIMUM 30 DAYS OF EXPERIENCE WITH APPROPRIATELY FIT HEARING AIDS.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OAF Implant, Hearing, Active, Middle Ear, Totally Implanted