BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Cochlear

    PMA: P000025 · Decision Aug 20, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22

    Basic Information

    Device Name
    Implant, Cochlear
    Trade Name
    COMBI 40+ COCHLEAR IMPLANT SYSTEM
    PMA Number
    P000025
    Device Class
    FDA Class 3
    Product Code
    MCM
    Generic Name
    Implant, cochlear
    Medical Specialty
    Unknown
    Advisory Committee
    Ear, Nose, Throat
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 20, 2001
    Date Received
    June 29, 2000
    Expedited Review
    N
    Docket Number
    02M-0006

    Advisory Committee Statement

    APPROVAL FOR THE MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM (COMBI 40+). THE DEVICE IS INTENDED TO PROVIDE THE OPPORTUNITY TO DETECT AND RECOGNIZE AUDITORY INFORMATION THROUGH ELECTRICAL STIMULATION OF THE AUDITORY NERVE FOR SERVER TO PROFOUNDLY HEARING-IMPAIRED INDIVIDUALS WHO OBTAIN LITTLE OR NO BENEFIT FROM CONVENTIONAL ACOUSTIC AMPLIFICATION IN THE BEST-AIDED CONDITION. THE COMBI 40+ IS INDICATED FOR THE FOLLOWING PATIENT POPULATIONS: ADULTS OF EIGHTEEN (18) YEARS OF AGE OR OLDER WHO HAVE BILATERAL, SENSORINEURAL HEARING IMPAIRMENT AND OBTAIN LIMITED BENEFIT FROM APPROPRIATELY FITTED BINAURAL HEARING AIDS. THESE INDIVIDUALS TYPICALLY DEMONSTRATE BILATERAL SEVERE TO PROFOUND SENSORINEURAL HEARING LOSS DETERMINED BY A PURE TONE AVERAGE OF 70 DB OR GREATER AT 500 HZ, 1000 HZ, AND 2000 HZ. LIMITED BENEFIT FROM AMPLIFICATION IS DEFINED BY TEST SCORES OF 40% CORRECT OR LESS IN BEST-AIDED LISTENING CONDITION ON CD RECORDED TESTS OF OPEN-SET SENTENCE RECOGNITION HEARING IN NOISE TEST (HINT) SENTENCES. CHILDREN AGED EIGHTEEN (18) MONTHS TO SEVENTEEN (17) YEARS ELEVEN (11) MONTHS MUST DEMONSTRATE A PROFOUND, BILATERAL SENSORINEURAL HEARING LOSS WITH THRESHOLDS OF 90 DB OR GREATER AT 1000HZ. IN YOUNGER CHILDREN, LITTLE OR NO BENEFIT IS DEFINED BY LACK OF PROGRESS IN THE DEVELOPMENT OF SIMPLE AUDITORY SKILLS IN CONJUNCTION WITH APPROPRIATE AMPLIFICATION AND PARTICIPATION IN INTENSIVE AURAL HABILITATION OVER A THREE (3) TO SIX (6) MONTH PERIOD. IN OLDER CHILDREN, LACK OF AIDED BENEFIT IS DEFINED AS < 20% CORRECT ON THE MULTI-SYLLABIC LEXICAL NEIGHBORHOOD TEST (MLNT) OR LEXICAL NEIGHBORHOOD TEST (LNT), DEPENDING UPON THE CHILD'S COGNITIVE ABILITY AND LINGUISTIC SKILLS. A THREE (3) TO SIX (6) MONTH HEARING AID TRIAL IS REQUIRED FOR CHILDREN WITHOUT PREVIOUS EXPERIENCE WITH HEARING AIDS. RADIOLOGICAL EVIDENCE OF COCHLEAR OSSIFICATION MAY JUSTIFY A SHORTER TRIAL WITH AMPLIFICATION.

    Classifications

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

    Product Code Device Name
    MCM Implant, Cochlear