BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JABRA ENHANCE PRO HEARING AIDS

    MDR report key: 13721021 · Received March 9, 2022

    Report

    Report Number
    MW5108012
    Event Type
    Malfunction
    Date Received
    March 9, 2022
    Date of Event
    March 8, 2022
    Report Date
    March 8, 2022
    Manufacturer
    GN HEARING A/S
    Product Code
    QDD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I PURCHASED JABRA ENHANCE PRO HEARING AIDS FROM COSTCO. THESE MEDICAL DEVICES ARE ADVERTISED TO INCLUDE BLUETOOTH COMPATIBLE WITH ANDROID PHONES. MY PHONE, A SAMSUNG S20 IS ON THEIR LIST OF APPROVED AND COMPATIBLE PHONES. MY HEARING AIDS DO NOT CONNECT TO BOTH HEARING AIDS AT ONCE, ONLY ONE SIDE CONNECTS AT ANY GIVEN TIME, AND IT ALTERNATES BETWEEN THE LEFT AND RIGHT AID, BUT NEVER TO BOTH HEARING AIDS AT THE SAME TIME. WHEN I CALLED JABRA SUPPORT, THEY ADMITTED TO THIS PROBLEM BUT BLAMED MY PHONE. IF YOU LOOK AT THE REVIEWS FOR THEIR APP IN THE GOOGLE PLAY STORE YOU CAN SEE EVERYONE IS HAVING THIS ISSUE. SINCE THESE ARE MEDICAL DEVICES, I FEEL I WAS LIED TO AND THAT JABRA/GN IS GUILTY OF FALSE ADVERTISEMENT OF MEDICAL DEVICES. JABRA ADMITTED THEY HAVE NO FORECAST TO CORRECT THIS DEFICIENCY IN THEIR PRODUCT, YET STILL ADVERTISE THAT THESE MEDICAL DEVICES ARE ANDROID COMPATIBLE, WHICH THEY ARE NOT. JABRA TRIES TO BLAME ANDROID 12 UPDATE, BUT EVERY ANDROID PHONE IS AT ANDROID 12 SO HOW CAN THEY CONTINUE TO FALSELY ADVERTISE THESE MEDICAL DEVICES AS ANDROID/BT COMPATIBLE? ALSO, ANDROID 12 HAS BEEN OUT FOR ALMOST HALF A YEAR, MORE THAN ENOUGH TIME TO FIX ANY ISSUES. FDA SAFETY REPORT ID #:(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1884494 JABRA ENHANCE PRO HEARING AIDS SELF-FITTING AIR-CONDUCTION HEARING AID QDD GN HEARING A/S ENHANCE PRO

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male