BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SONIC INNOVATIONS, INC.

    MDR report key: 2525302 · Received March 19, 2012

    Report

    Report Number
    1724310-2012-00003
    Event Type
    Malfunction
    Date Received
    March 19, 2012
    Date of Event
    February 23, 2012
    Report Date
    March 16, 2012
    Manufacturer
    SONIC INNOVATIONS, INC.
    Product Code
    ESD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT RECORD INDICATES THAT THE HEARING CARE PROFESSIONAL REPORTED THAT DOMES FELL OFF THE RECEIVERS REQUIRING INTERVENTION TO REMOVE THE DOMES FROM THE EAR CANAL. THERE WAS NO INDICATION THAT ANY INJURY OCCURRED AS A RESULT OF THE EVENT. NO DEVICE (S) WERE RETURNED FOR EVALUATION. THE FLIP HEARING INSTRUMENTS (HI) IS A BEHIND THE EAR (BTE) RECEIVER IN THE CANAL (RIC) CLASS I DEVICE HEARING AID. THE EXTERNAL SPEAKER IS POSITIONED IN THE EAR CANAL. AS PART OF THE FITTING PROCESS THE HEARING CARE PROFESSIONAL DETERMINES THE FIT AND POSITION OF THE SPEAKER. A SILICONE DOME IS ATTACHED, EMPLOYING A SNAP FIT DESIGN, TO THE SPEAKER TO FACILITATE SPEAKER POSITION WITHIN THE EAR CANAL. THE DOMES ARE CONSIDERED SERVICE ITEMS THAT REQUIRE PERIODIC REPLACEMENT. THE HEARING AID USER OR HEARING CARE PROFESSIONAL CAN REPLACE THE DOMES BY FOLLOWING THE REPLACEMENT INSTRUCTIONS CONTAINED IN THE USER GUIDE AND DIRECTIONS ON THE DOME PACKAGING. IN THE EVENT, THE DOME BECOMES DETACHED FROM THE SPEAKER, WITHIN THE EAR CANAL, THE USER GUIDE INSTRUCTS THE PT TO HAVE A DOCTOR REMOVE THE DOME. NO ADDITIONAL EVALUATION WAS PERFORMED SINCE NO DEVICES WERE RETURNED DURING THE TIME PERIOD OF THIS EVENT.

    Description of Event or Problem · 1

    HEARING CARE PROVIDER DESCRIBED EVENT AS DOMES COMING OFF RECEIVERS (SPEAKERS) INSIDE EAR CANAL REQUIRING INTERVENTION TO REMOVE THE DOMES. THE HEARING CARE PROVIDER INDICATED THEY NOTICED SOME DISCOLORATION OF DOMES THAT HAD COME OFF. THE HEARING CARE PROVIDER INDICATED THAT THEY WILL RETURN EXAMPLES OF THESE DOMES FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SONIC INNOVATIONS, INC. HEARING AID ESD SONIC INNOVATIONS, INC. FLIP 100 NOT APPLICABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention