BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

    PMA: P130016 · Decision Mar 20, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11

    Basic Information

    Device Name
    Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification
    Trade Name
    NUCLEUS HYBRID L24 COCHLEAR IMPLANT SYSTEM
    PMA Number
    P130016
    Device Class
    FDA Class 3
    Product Code
    PGQ
    Generic Name
    Cochlear implant with combined electrical stimulation and acoustic amplification
    Medical Specialty
    Unknown
    Advisory Committee
    Ear, Nose, Throat
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 20, 2014
    Date Received
    June 3, 2013
    Expedited Review
    Y
    Docket Number
    14M-0327

    Advisory Committee Statement

    APPROVAL FOR THE NUCLEUS® HYBRID L24 COCHLEAR IMPLANT SYSTEM. THE NUCLEUS® HYBRID L24 COCHLEAR IMPLANT SYSTEM IS INTENDED TO PROVIDE ELECTRIC STIMULATION TO THE MID-TO-HIGH FREQUENCY REGION OF THE COCHLEA AND ACOUSTIC AMPLIFICATION TO THE LOW FREQUENCY REGIONS, FOR PATIENTS WITH RESIDUAL LOW FREQUENCY HEARING SENSITIVITY. THE SYSTEM IS INDICATED FOR UNILATERAL USE IN PATIENTS AGED 18 YEARS AND OLDER WHO HAVE RESIDUALLOW-FREQUENCY HEARING SENSITIVITY AND SEVERE TO PROFOUND HIGH FREQUENCY SENSORINEURAL HEARING LOSS, AND WHO OBTAIN LIMITED BENEFIT FROM APPROPRIATELY FIT BILATERAL HEARING AIDS. TYPICAL PREOPERATIVE HEARING OF CANDIDATES RANGES FROM NORMAL TO MODERATE HEARING LOSS IN THE LOW FREQUENCIES (THRESHOLDS NO POORER THAN 60 DB HL UP TO AND INCLUDING 500 HZ), WITH SEVERE TO PROFOUND MID TO HIGH FREQUENCY HEARING LOSS (THRESHOLD AVERAGE OF 2000, 3000, AND 4000 HZ >=75 DB HL) IN THE EAR TO BE IMPLANTED, AND MODERATELY SEVERE TO PROFOUND MID TO HIGH FREQUENCY HEARING LOSS (THRESHOLD AVERAGE OF 2000, 3000, AND 4000 HZ >=60 DB HL) IN THE CONTRALATERAL EAR. THE CNC WORD RECOGNITION SCORE WILL BE BETWEEN 10% AND 60%, INCLUSIVELY, IN THE EAR TO BE IMPLANTED IN THE PREOPERATIVE AIDED CONDITION AND IN THE CONTRALATERAL EAR WILL BE EQUAL TO OR BETTER THAN THAT OF THE EAR TO BE IMPLANTED BUT NOT MORE THAN 80% CORRECT. PROSPECTIVE CANDIDATES SHOULDGO THROUGH A SUITABLE HEARING AID TRIAL, UNLESS ALREADY APPROPRIATELY FIT WITH HEARING AIDS.

    Classifications

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

    Product Code Device Name
    PGQ Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification