BEUDAMED
    FDA Adverse Event Other Summary report: N

    RESOURCE PIXEL MINI

    MDR report key: 781242 · Received November 13, 2006

    Report

    Report Number
    MW1040958
    Event Type
    Other
    Date Received
    November 13, 2006
    Date of Event
    November 7, 2006
    Report Date
    November 13, 2006
    Manufacturer
    GN RESOUND NORTH AMERICA
    Product Code
    ESD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    I HAVE BEGUN USING NEWLY PRESCRIBED HEARING AIDS RESOUND PIXEL MINI BTE PL60-DI FOR BOTH EARS FOR BILATERAL HEARING LOSS, SENSORINEURAL AND OLD AGE HEARING PROBLEMS. IF FOUND THAT INTERMITTENTLY I WAS NOT HEARING WELL WITH THE NEW HEARING AID AND COULD NOT HEAR THE BEEPS EVEN THAT ALLOWED ME TO KNOW WHICH PROGRAM I WAS USING. IT APPEARED VERY DELICATE AND POSITIONAL. VERY FRUSTRATING, BECAUSE UNLESS I HELD THE TUBING ATTACHED TO THE HEARING AID IN A PARTICULAR FASHION AND POSITION THE HEARING AID, DID NOT FUNCTION. ALSO, UNLESS I PERIODICALLY TESTED THE PROGRAM IT WAS IN IT DID NOT ALLOW ME TO DETERMINE THAT THE HEARING AID WAS NOT PROPERLY FUNCTIONING. AFTER 2 VISITS TO THE AUDIOLOGIST AND HOURS OF FRUSTRATION IT WAS DETERMINED THAT THE TUBING ATTACHMENT HAD A NARROWED OPENING OR CHANNEL AT THE CURVATURE AND WAS NOT ALLOWING AIR - NOISE - TO PROPERLY ENTER THE HEARING AID. I AM CONCERNED MANY MORE PTS MAY BE UNKNOWINGLY NOT GETTING THE BENEFIT OF THEIR HEARING AID...IT HAS NOW TAKEN SEVERAL REPLACEMENTS OF THE TUBING TO CORRECTLY GET THE DESIGN TUBING TO BE CORRECT. THIS APPEARS TO BE A FLAW IN THE DESIGN THAT SIGNIFICANTLY AFFECTS PT CARE AND THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOURCE PIXEL MINI HEARING AID ESD GN RESOUND NORTH AMERICA * *

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other