BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GN RESOUND

    MDR report key: 10501075 · Received September 8, 2020

    Report

    Report Number
    3005650109-2020-00031
    Event Type
    Injury
    Date Received
    September 8, 2020
    Date of Event
    August 10, 2020
    Report Date
    October 15, 2020
    Manufacturer
    GN HEARING A/S
    Product Code
    OSM
    UDI-DI
    05708296095063
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    FINAL REPORT CONCLUSION: AFTER INVESTIGATING THE RETURNED DEVICE WE CAN CONCLUDE THAT THE DEVICE APEARS TO PERFORM ACCORDING TO SPECIFICATIONS. ALSO THE CLINICAL EVALUATION CONCLUDES THAT: THE CLINICAL EVALUATION FOR THE DEVICE FAMILY DOES EVALUATE LOUD SOUNDS FROM THE HEARING AIDS AND THIS IS ADDRESSED IN THE RISK ANALYSIS AND MITIGATED TO AN ACCEPTABLE LIMIT BY BUILT-IN PROTECTIVE MEASURES IN THE DEVICE DESIGN. POTENTIAL MAXIMUM OUTPUT OF THE DEVICES IS LIMITED TO ~116 DB FOR A MP RECEIVER. CLINICAL CONCLUSION ON THE CASE IS THAT THE HEARING AIDS ARE PERFORMING AS EXPECTED AND EVEN THOUGH UNPLEASANT, MAXIMUM OUTPUT IS LIMITED TO ~116 DB SPL AND PERMANENT HARM TO RESIDUAL HEARING IS EVALUATED UNLIKELY. BASED ON THE ABOVE INVESTIGATION RESULTS AND CLINICAL EVALUATION WE CONCLUDE THAT THE HEARING AIDS ARE PERFORMING AS EXPECTED AND EVEN THOUGH UNPLEASANT, MAXIMUM OUTPUT IS LIMITED TO ~116 DB SPL AND PERMANENT HARM TO RESIDUAL HEARING IS EVALUATED UNLIKELY. NO SERIOUS INJURY INFLICTED AND WOULD NOT IF THE EVENT WERE TO RECUR. THIS EVENT IS THEREFORE FINALLY CONSIDERED TO BE NOT REPORTABLE.

    Description of Event or Problem · 0

    AS REPORTED BY THE LOCAL HEARING AID DEALER: PATIENT HAVING HIGH PAIN RELATED TO THE PROGRAMMING ON THE RIGHT AND I WANT THE LEFT TO BE CHECKED AS WELL. HE STATES THAT THE LEFT IS NOT THE ISSUE, BUT I WOULD LIKE TO HAVE A FULL CHECK OF THIS. CAN YOU PLEASE INCLUDE A DIAGNOSIS OF THIS ON THE PPWK THAT IS SENT BACK WITH THE DEVICE? PATIENT COMPLAINS OF CAUSING HIS RIGHT EAR TO HAVE A LOT OF PAIN. HE HAS LINX 2 DEVICES THAT DO NOT CAUSE PAIN AND THEY HAVE SIMILAR PROGRAMMING. I WOULD LIKE TO HAVE THIS DEVICE REPLACES IF POSSIBLE, AS I FEAR THERE IS SOMETHING WRONG WITH THE CIRCUITRY. INTERPRETATION BY THE COUNTRY SALES OFFICE: FIRST, I SHOULD MENTION THAT THE USER HAS BEEN WEARING THE REPLACEMENT DEVICES AND HAS NOT HAD THE ISSUE WITH PAIN. THE NEW DEVICES, PROGRAMMED USING THE SAME NOAH FILE, HAS NOT CAUSED THE USER TO REPORT HAVING ANY PAIN. SO THAT IS GOOD NEWS. I ASKED HCP TO EXPLAIN THE SITUATION. HE SAID HE COULD NOT DETERMINE THE CAUSE OF THE PAIN AND COULD NOT DETERMINE IF IT WAS PHYSICAL PAIN FROM THE DEVICE OR IF IT WAS A LOUD SOUND. THE HCP MADE MANY ADJUSTMENTS TO HOW THE DEVICE FIT ON THE EAR AND THE USER HAD LS61 DEVICES THAT DID NOT HAVE THIS ISSUE. AT THE SAME TIME, THE USER DID NOT REPORT A LOUD SOUND EITHER, HE ONLY REPORTED HAVING PAIN. HCP DID CALIBRATE THE DFS AND ADJUSTED THE GAIN OF THE DEVICE WHICH DID NOT SOLVE IT. USER DOES HAVE EXOTOSIS (SMALL BONY GROWTHS IN EAR CANAL) BUT THEY WERE DEEP ENOUGH TO NOT INTERACT WITH THE EARPIECE. USER WAS GIVEN DROPS BY THE ENT IN AN EFFORT TO MAKE SO THE PAIN WOULD BE ALLEVIATED IF IT WAS DUE TO SOME IRRITATION. THE ISSUE DOES SEEM TO BE RESOLVED WITH THE REPLACEMENT SET OF HEARING DEVICES. AN INITIAL REPORT, BASED ON THE ABOVE INFORMATION, WERE FILED AS WE WHERE RUNNING OUT OF TIME AND WE COULD NOT EXCLUDE THE POSSIBILITY THAT OUR DEVICE SOMEHOW CONTRIBUTED TO A POTENTIAL SERIOUS INJURY, DAMAGE OF THE REMAINING HEARING. IN THIS FINAL REPORT WE WILL HOWEVER CONCLUDE, BASED ON INVESTIGATIONS OF THE DEVICE IN QUESTION AND CLINICAL EVALUATIONS, THAT THERE WERE NO SERIOUS INJURY.

    Additional Manufacturer Narrative · 1

    WE WILL NOT BE ABLE TO FINALIZE INVESTIGATION IN TIME FOR THE 30 DAY TIME LIMIT, WHY THIS IS AN INITIAL REPORT.

    Description of Event or Problem · 1

    AS REPORTED BY THE LOCAL HEARING AID DEALER: PATIENT HAVING HIGH PAIN RELATED TO THE PROGRAMMING O THE RIGHT AND I WANT THE LEFT TO BE CHECKED AS WELL. HE STATES THAT THE LEFT IS NOT THE ISSUE, BUT I WOULD LIKE TO HAVE A FULL CHECK OF THIS. CAN YOU PLEASE INCLUDE A DIAGNOSIS OF THIS ON THE PPWK THAT IS SENT BACK WITH THE DEVICE? PATIENT COMPLAINS OF CAUSING HIS RIGHT EAR TO HAVE A LOT OF PAIN. HE HAS LINX 2 DEVICES THAT DO NOT CAUSE PAIN AND THEY HAVE SIMILAR PROGRAMMING. I WOULD LIKE TO HAVE THIS DEVICE REPLACES IF POSSIBLE, AS I FEAR THERE IS SOMETHING WRONG WITH THE CIRCUITRY. INTERPRETATION BY THE COUNTRY SALES OFFICE: FIRST, I SHOULD MENTION THAT THE USER HAS BEEN WEARING THE REPLACEMENT DEVICES AND HAS NOT HAD THE ISSUE WITH PAIN. THE NEW DEVICES, PROGRAMMED USING THE SAME NOAH FILE, HAS NOT CAUSED THE USER TO REPORT HAVING ANY PAIN. SO THAT IS GOOD NEWS. I ASKED HCP TO EXPLAIN THE SITUATION. HE SAID HE COULD NOT DETERMINE THE CAUSE OF THE PAIN AND COULD NOT DETERMINE IF IT WAS PHYSICAL PAIN FROM THE DEVICE OR IF IT WAS A LOUD SOUND. THE HCP MADE MANY ADJUSTMENTS TO HOW THE DEVICE FIT ON THE EAR AND THE USER HAD LS61 DEVICES THAT DID NOT HAVE THIS ISSUE. AT THE SAME TIME, THE USER DID NOT REPORT A LOUD SOUND EITHER, HE ONLY REPORTED HAVING PAIN. HCP DID CALIBRATE THE DFS AND ADJUSTED THE GAIN OF THE DEVICE WHICH DID NOT SOLVE IT. USER DOES HAVE EXOTOSIS (SMALL BONY GROWTHS IN EAR CANAL) BUT THEY WERE DEEP ENOUGH TO NOT INTERACT WITH THE EARPIECE. USER WAS GIVEN DROPS BY THE ENT IN AN EFFORT TO MAKE SO THE PAIN WOULD BE ALLEVIATED IF IT WAS DUE TO SOME IRRITATION. THE ISSUE DOES SEEM TO BE RESOLVED WITH THE REPLACEMENT SET OF HEARING DEVICES. WE WILL NOT BE ABLE TO FINALIZE INVESTIGATION IN TIME FOR THE 30 DAY TIME LIMIT, WHY THIS IS AN INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    966607 GN RESOUND LT961-DRWZ,RESOUND LINX3D 9 OSM GN HEARING A/S LT961-DRWZ,RESOUND LINX3D 9,GN RESOUND 05708296095063

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention