BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Cochlear

    PMA: P840024 · Supplement: S070 · Decision Jun 11, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22

    Basic Information

    Device Name
    Implant, Cochlear
    Trade Name
    NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM
    PMA Number
    P840024
    Supplement Number
    S070
    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
    June 11, 1997
    Date Received
    April 24, 1997
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO IMPLEMENT A DESIGN CHANGE TO THE TWO-PIN SOCKET ON THE HEADSET MICROPHONE. THE TRANSMITTING COIL IS CONNECTED TO THE MICROPHONE VIA A CABLE WHICH IS PLUGGED INTO THIS TWO-PINC SOCKET. THIS CHANGE WOULD ALSO ENTAIL MAKING A SLIGHT MODIFICATION TO THE DESIGN OF THE SHELL OF THE HEADSET MICROPHONE IN ORDER TO ACCOMMODATE THE NEW DESIGN OF THE TWO-PIN SOCKET. THE NUCLEUS 22 CHANNEL COCHLEAR IMPLANT IS INDICATED FOR USE IN ADULTS WITH BILATERAL, SENSORINEURAL, SEVERE-TO-PROFOUND DEAFNESS, AGES 18 YEARS AND OLDER, WHO OBTAIN UP TO 30% SPEECH RECOGNITION ON TESTS OF RECORDED SENTENCE MATERIALS IN THE BEST-AIDED CONDITION. IT IS INDICATED FOR USE IN CHILDREN WITH BILATERAL, SENSORINEURAL, PROFOUND DEAFNESS, AGES 2 YEARS TO 17 YEARS, WHO OBTAIN LITTLE OR NOT BENEFIT FROM CONVENTIONAL AMPLIFICATION IN THE BEST-AIDED TEST CONDITION.

    Classifications

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

    Product Code Device Name
    MCM Implant, Cochlear