BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SONIC INNOVATIONS

    MDR report key: 2434880 · Received January 26, 2012

    Report

    Report Number
    1724310-2012-00002
    Event Type
    Malfunction
    Date Received
    January 26, 2012
    Date of Event
    May 10, 2011
    Report Date
    January 24, 2012
    Manufacturer
    SONIC INNOVATIONS, INC.
    Product Code
    ESD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT RECORD INDICATES THAT THE HEARING CARE PROFESSIONAL, AUDIOLOGY ASSOCIATES, (B)(6), REPORTED THAT A PT, WEARING TOUCH MODEL HEARING AIDS, HAD BOTH DOMES FALL OFF THE SPEAKERS IN THE EAR CANAL WHICH REQUIRED INTERVENTION TO REMOVE THE DOMES FROM THE PTS EARS. THERE WAS NO INDICATION THAT ANY INJURY OCCURRED AS A RESULT OF THIS EVENT. NO DEVICE(S) WERE RETURNED FOR EVAL. THE MODEL TOUCH IS A RECEIVER-(SPEAKER) IN-THE-EAR (RITE) HEARING AID BEHIND-THE-EAR (BTE) CLASS I DEVICE THAT HAS AN EXTERNAL SPEAKER POSITIONED WITHIN THE EXTERNAL AUDITORY CANAL (EAR CANAL). AS PART OF THE FITTING FOR THE PT A HEARING CARE PROFESSIONAL WOULD DETERMINE THE FIT AND POSITIONING 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 THEIR HEARING CARE PROFESSIONAL CAN REPLACE THE DOMES BY FOLLOWING THE REPLACEMENT INSTRUCTIONS CONTAINED IN THE USER GUIDE AND DIRECTIONS ON THE DOME PACKAGING. EAR CANAL LENGTHS RANGE FROM 25 TO 30MM. SPEAKER PLACEMENT IN THE EAR CANAL EXTENDS IN 15MM LEAVING A 10 TO 15 MM SPACE BETWEEN THE SPEAKER AND THE TYMPANIC MEMBRANE (EAR DRUM). IN THE EVENT A DOME BECOMES DETACHED FROM THE SPEAKER WITHIN THE EAR CANAL THE USER GUIDE INSTRUCTS THE PT TO HAVE A DOCTOR REMOVE THE DOME. DEVICES FROM A CONTROLLED SAMPLE WERE EVALUATED FOR PROPER SNAP FIT BETWEEN THE DOME AND SPEAKER. THE DOMES WERE ATTACHED TO THE SPEAKERS PER THE USER GUIDE INSTRUCTIONS WITH NO ATTACHMENT OR DETACHMENT ISSUES NOTED. NO INTEROPERABILITY PROBLEMS WERE OBSERVED BASED ON THE SAMPLE EVALUATION. NO EVALUATION RESULTS ARE AVAILABLE FROM THE ACTUAL DEVICE(S) THAT CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. A REVIEW OF THE CUSTOMER ALERT (COMPLAINT) LOGS (FOR THE CALENDAR YEAR 2011 THROUGH TO THIS REPORT DATE) SHOWS NO TRENDS OR ALERT CONDITIONS REQUIRING FURTHER INVESTIGATION AT THIS TIME. THE INITIAL REPORTER INDICATED BOTH DOMES CAME OFF THE SPEAKERS WHICH WOULD INDICATE THE EVENT IS CONSISTENT WITH IMPROPER INSTALLATION OF THE DOMES.

    Description of Event or Problem · 1

    PT WAS WEARING BEHIND THE EAR (BTE) HEARING AIDS WITH IN-THE-EAR (ITE) SPEAKERS. DOMES, WHICH HOLD THE SPEAKERS IN THE PROPER POSITION IN THE EAR CANAL CAME OFF REQUIRING INTERVENTION TO REMOVE THE DOMES FROM THE EAR CANAL. THE EVENT OCCURRED ON THE WEEKEND REQUIRING THE PT TO GO TO THE EMERGENCY ROOM TO HAVE THE DOMES REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SONIC INNOVATIONS HEARING AID ESD SONIC INNOVATIONS, INC. TOUCH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention