BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Hearing, Active, Middle Ear, Totally Implanted

    PMA: P090018 · Decision Mar 17, 2010
    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 TOTALLY IMPLANTABLE HEARING SYSTEM
    PMA Number
    P090018
    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
    March 17, 2010
    Date Received
    August 4, 2009
    Expedited Review
    Y
    Docket Number
    10M-0244

    Advisory Committee Statement

    APPROVAL FOR THE ESTEEM. THE ESTEEM IS INTENDED TO ALLEVIATE HEARING LOSS IN PATIENTS 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 TUBE;6) NORMAL MIDDLE EAR ANATOMY;7) NORMAL TYMPANIC MEMBRANE;8) ADEQUATE SPACE FOR ESTEEM IMPLANT DETERMINED VIA A HIGH RESOLUTION CT SCAN; AND9) 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