BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GN RESOUND

    MDR report key: 17660094 · Received August 31, 2023

    Report

    Report Number
    3005650109-2023-00128
    Event Type
    Injury
    Date Received
    August 31, 2023
    Date of Event
    July 1, 2023
    Report Date
    August 31, 2023
    Manufacturer
    GN HEARING A/S
    Product Code
    OSM
    UDI-DI
    2303071755
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S REF# (B)(4). TECHNICAL INVESTIGATION CONCLUDED: A DEVICE HISTORY RECORD REVIEW HAVE BEEN COMPLETED. NO DEVIATION OR CHANGES WERE FOUND DURING MANUFACTURING OF THE DEVICE. NO DEVICE HAS BEEN RETURNED. THE CLINICAL INVESTIGATION CONCLUDED: IT IS REPORTED THAT THE USER DEVELOPED AN EAR INFECTION 2-3 DAYS AFTER HE STARTED WEARING HIS HEARING AIDS AFTER A REMAKE. IT IS UNKNOWN IF THE EAR INFECTION WAS IN THE EAR CANAL OR IN THE MIDDLE EAR. THE USER EXPERIENCED PAIN IN THE EAR, WHICH IS WHAT PROMPTED HIM TO GO TO THE DOCTOR, WHO DIAGNOSED THE EAR INFECTION. THE TYPE OF HEARING AIDS IS IN-THE-EAR, AND THE SYMPTOMS WERE PRESENT ONLY ON THE LEFT EAR. USER THEN WENT TO THE DOCTOR AND WAS GIVEN ANTIBIOTICS. AT THE TIME OF THE REPORT, HE WAS NO LONGER TAKING MEDICATION, AND FELT HIS EAR WAS CLOSE TO BEING BACK TO NORMAL. THIS IS THE FIRST TIME IT HAS HAPPENED TO THE USER. THERE WERE NOT REPORTED PRESSURE POINT OF THE HEARING AID, WHICH WERE CAUSING DISCOMFORT. THERE IS NO HISTORY OF ALLERGIES, HYPERSENSITIVITY OR FUNGAL INFECTIONS FOR THE USER. IT IS UNKNOWN IF THE USER HAD A HISTORY OF EAR INFECTIONS. NO DETAILS OF THE INFECTION (TYPE, LOCATION) HAVE BEEN PROVIDED. AS HEARING AIDS WILL NEED TO HAVE SKIN CONTACT, THE RISK OF EAR INFECTION IS PRESENT. PRIMARY INFECTIONS FROM HEARING AIDS IS NOT POSSIBLE AS HEARING AIDS ARE MADE OF NON-BIOLOGICAL MATERIAL. HOWEVER, THE RISK OF INFECTION IN EARS CAN INCREASE WITH THE USE OF HEARING AIDS. HUMAN SKIN IS REGULARLY CONTAMINATED, AND DAILY HANDLING OF HEARING AIDS INCREASES THE RISK OF TRANSFERRING BACTERIA TO THE EARS. IN RARE CASES A FUNGAL INFECTION IN THE EAR CANAL CAN DEVELOP. THESE INFECTIONS HAVE GOOD CIRCUMSTANCES IN DARK AND HUMID ENVIRONMENTS AND IS TYPICALLY SEEN IN MORE OCCLUDED FITTINGS (CUSTOM EAR MOULDS/SHELLS) WHERE ADEQUATE AIR VENTILATION IN THE EAR CANAL IS PREVENTED. FUNGAL INFECTIONS CAN BE TREATED WITH MEDICAL PRESCRIPTIONS AND PROPER VENTILATION IN THE EAR MOULDS/SHELLS. IF THE FUNGAL INFECTION IS RECURRENT, REMOVING THE HEARING AID WHENEVER IT IS NOT BEING ACTIVELY USED AND CLEANING THE HEARING AID CAN HELP PREVENT IT. THE USER GUIDE INCLUDES A CAUTION THAT HEARING AIDS SHOULD BE CLEANED DAILY TO AVOID SKIN IRRITATION OR INFECTION FROM EAR WAX OR OTHER RESIDUE ON THE HEARING AIDS. HEARING AIDS, BY DESIGN, ARE MEANT TO BE WORN IN/ON THE EAR AND HANDLED BY THE END USER AND HEARING CARE PROFESSIONAL. AS THE DEVICES ARE PHYSICALLY TOUCHING THE EAR/EAR CANAL THERE ARE RISKS OF INFECTION IN CASES WHERE THERE WAS CONTAMINATED HANDLING OFTEN DEVICES OR IMPROPER CLEANING, SHOULD A DETACHABLE PORTION OF THE HEARING AID (E.G., DOME, WAX FILTER) BECOME LODGED IN THE EAR CANAL, OR AS, ABOVE, A DAMAGED DEVICE CAUSING CUTS/SCRATCHES TO THE EAR RESULTING IN INFECTION. IMPROPER CLEANING OF HEARING AIDS AND/OR EAR MOLDS CAN ALSO IN RARE CASES CAUSE CONTAMINATION RESULTING IN IRRITATION, INFECTION, OR ALLERGIC REACTIONS. USERS OF HEARING AIDS ARE TO BE GUIDED IN HOW TO MAINTAIN THEIR HEARING AIDS AND INFORMATION CAN ALSO BE FOUND IN USER GUIDES. THIS TO MINIMIZE THE RISK OF IRRITATION, INFECTION OR ALLERGIC REACTIONS. IT IS CONCLUDED THAT THE BENEFIT OF WEARING A HEARING AID OUTWEIGHS THIS RISK. RISK REGISTER CONCLUSION REFERENCE: ADDITIONAL RISK ID BASED ON CLINICAL EVALUATION: (B)(4). KNOWN RISKS, RISK CONTROLS IN PLACE AND CHECKED. DEEMED TO BE ACCEPTABLE. MANUFACTURER'S INVESTIGATION IS FINAL. THIS IS A COMBINED (INITIAL AND FINAL) REPORT. NO FURTHER INFORMATION IS EXPECETED.

    Description of Event or Problem · 0

    ON AN UNKNOWN DATE IN JULY, IT WAS REPORTED THAT THE USER DEVELOPED AN EAR INFECTION. THE SYMPTOMS WERE PAIN, WHICH OCCURED 2-3 DAYS AFTER HE STARTED WEARING HIS HEARING AIDS, UPON RECEVING THEM AFTER A REMAKE. IT IS UNKNOWN IF THE EAR INFECTION WAS IN THE EAR CANAL OR IN THE MIDDLE EAR. THE USER EXPERIENCED PAIN IN THE EAR, WHICH IS WHAT PROMPTED HIM TO GO TO THE DOCTOR, WHO DIAGNOSED THE EAR INFECTION AND PRESCRIPBED ANTIBIOTICS. THE TYPE OF HEARING AIDS IS IN-THE-EAR, AND THE SYMPTOMS WERE PRESENT ONLY ON THE LEFT EAR. AT THE TIME OF THE REPORT, HE WAS NO LONGER TAKING MEDICATION, AND FELT HIS EAR WAS CLOSE TO BEING BACK TO NORMAL. THIS IS THE FIRST TIME IT HAS HAPPENED TO THE USER. THERE WERE NOT REPORTED PRESSURE POINT OF THE HEARING AID, WHICH WERE CAUSING DISCOMFORT. THERE IS NO HISTORY OF ALLERGIES, HYPERSENSITIVITY OR FUNGAL INFECTIONS FOR THE USER. IT IS UNKNOWN IF THE USER HAD A HISTORY OF EAR INFECTIONS. NO DETAILS OF THE INFECTION (TYPE, LOCATION) HAVE BEEN PROVIDED. NO FURTHER INFORMATION IS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1514251 GN RESOUND HEARING AID, , AIR CONDUCTION WITH WIRELESS TECHNOLOGY OSM GN HEARING A/S RT7ITE-DWC-MP 2303071755

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other