BEUDAMED
    FDA Adverse Event Summary report: N

    AURA

    MDR report key: 458104 · Received April 9, 2003

    Report

    Report Number
    MW4003508
    Date Received
    April 9, 2003
    Report Date
    April 9, 2003
    Manufacturer
    OTICON CORP
    Product Code
    ESD
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CONSUMER HAS BEEN HAVING TROUBLES WITH THEIR PROGRAMMABLE HEARING AIDS FOR 2.5 YEARS. PROBLEMS INCLUDE WHISTLING NOISES AND REPEATED COMPLETE FAILURES. THE HEARING AIDS HAVE BEEN RETURNED TO THE MFR NUMBEROUS TIMES TO BE REWORKED AND PT SAYS THEY ARE NEVER FIXED AND THEY ALMOST NEVER WORK. PT SAID THAT THE SPECIALISTS THEY HAVE SEEN SAY THE PROBLEM IS A CHIP PROBLEM AND THE MFR SAYS IT IS AN AMPLIFIER PROBLEM. PT HAS WORKED WITH NUMEROUS SPECIALISTS AND IT CAN'T BE FIXED. PT SAYS IT IS A LEMON BUT THE MFR WILL NOT GIVE THEM A NEW ONE OR REIMBURSE THEIR MONEY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AURA 700 CANALS-PROGRAMMABLE HEARING AID ESD OTICON CORP * *
    2 AURA 700 CANALS-PROGRAMMABLE HEAING AID ESD OTICON CORP * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *