BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARING AID AUDIBEL

    MDR report key: 6428055 · Received March 20, 2017

    Report

    Report Number
    MW5068617
    Event Type
    Malfunction
    Date Received
    March 20, 2017
    Report Date
    March 20, 2017
    Manufacturer
    STARKEY LABORATORIES INC
    Product Code
    LXB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    WITH THE AID OF INSURANCE, I PURCHASED HEARING AIDS FROM AUDIBEL. THE PURCHASE WAS EITHER 2014 OR 2015. IF THE EXACT DATE IS NECESSARY I CAN FIND IT. THE LEFT ONE. SERIAL NUMBER (B)(4), I HAVE SENT BACK FOR REPAIR APPROXIMATELY A DOZEN TIMES. THE MAIN COMPLAINT, VERY SHORT BATTERY LIFE, FOR WHICH IT HAS BEEN SENT BACK FOR MOST OF THOSE TIMES, HAS NEVER BEEN RESOLVED. SEVERAL TIMES THE AID WAS RETURNED WITH A CARD SHOWING THE AID PASSED A TEST FOR "BATTERY DRAINAGE." I STILL HAVE SOME OF THOSE CARDS. THE IMPLICATION IS THE AID IS FUNCTIONING PROPERLY. THE AID LOOSES POWER FAR TOO QUICKLY, FREQUENTLY WITHOUT WARNING, AND I LOOSE HEARING IN THAT EAR HOWEVER, I HAVE BEEN TOLD IT IS POSSIBLE TO ADDRESS THE AID TO DETERMINE BATTERY LIFE. IF THAT IS TRUE THE AUDIBEL IS DELIBERATELY USING THE WRONG TEST. THIS APPEARS TO ME TO BE AT LEAST DECEPTIVE AND PERHAPS A FRAUD IN INTERSTATE COMMERCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199632 HEARING AID AUDIBEL HEARING AID AUDIBEL LXB STARKEY LABORATORIES INC

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other