BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GN RESOUND

    MDR report key: 14564218 · Received June 1, 2022

    Report

    Report Number
    3005650109-2022-00006
    Event Type
    Injury
    Date Received
    June 1, 2022
    Report Date
    June 28, 2022
    Manufacturer
    GN HEARING A/S
    Product Code
    OSM
    UDI-DI
    05708296174898
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S REFERENCE NUMBER: (B)(4): CLINICAL EVALUATION OF THE EVENT: END USER IS CURRENTLY EXPERIENCING DRAINAGE AND REDNESS AND PAIN IN BOTH EARS THAT IS CURRENTLY BEING TREATED WITH ANTIBIOTICS. THE HCP IS RECOMMENDING THAT THE END USER STOP WEARING THE DEVICE FOR A WEEK AND IS RECOMMENDING A DEVICE WITH MORE VENTILATION. IT APPEARS THAT THE DEVICES THEMSELVES ARE NOT CAUSING THE INFECTION, BUT, INSTEAD THAT THE AIR IS NOT PROPERLY VENTED BASED ON THE REQUIREMENTS FOR THE END USER. CLINICAL CONCLUSION IS THAT THE HEARING AIDS MAY BE CONTRIBUTING TO THE INFECTION, BUT NOT CAUSING THE INFECTION FROM A BIOCOMPATIBILITY STANDPOINT. CLINICAL EVALUATION ACCORDING TO 0378040 CLIN EVAL PLAN&RPT,HA&TSG: AS HEARING AIDS ARE DESIGNED TO HAVE SKIN CONTACT, THE MATERIAL USED IS BIOCOMPATIBLE AND A BIOLOGICAL EVALUATED ACCORDING TO PROCEDURE # (B)(4) CORP PROC,BIOL EVALUATION. HEARING AIDS ARE TYPICALLY BEING WORN MANY HOURS PER DAY AND IT IS NOT UNCOMMON THAT THE SKIN CONTACT CAN CAUSE MINOR SKIN IRRITATION. HOWEVER, MANY USERS GET ACCUSTOMED TO THE MATERIAL AND THE ITCHING OR IRRITATION. IN RARE CASES, A REACTION CAN DEVELOP. IN SOME CASES, TREATMENT WITH TOPICAL STEROID AND/OR ANTIBIOTICS WILL BE NECESSARY TO STOP THE SKIN IRRITATION. A TEMPORARY PAUSE IN THE HEARING AID USE, OR MODIFICATION TO THE HEARING AID SHAPE BY THE HEARING CARE PROFESSIONAL, IS ALSO RECOMMENDED TO HELP THE HEALING PROCESS. THE USER GUIDE INCLUDES A CAUTION TO CONSULT THE HEARING CARE PROFESSIONAL IF IRRITATION SHOULD OCCUR. IN THIS CASE, BOTH THE HCP AND A PCP HAS BEEN CONSULTED. THERE ARE NO NEW CLINICAL ASPECTS (E.G. UNFORESEEN USE OR CLINICAL CONDITIONS) DISCOVERED FROM THIS EVENT. THEREFORE, IT IS CONCLUDED THAT THE CURRENT CLINICAL EVALUATION AND RISK/BENEFIT CONCLUSIONS HEREIN ARE SUFFICIENT. RISK REGISTER REFERENCE: (B)(4) GEN BTE & ITE RISK ANALYSIS RISK ID U.1-8A FAIL TO IDENTIFY HYPER-SENSITIVITY. THE SPECIFIED ABOVE RISK OF HYPER-SENSITIVITY TO MATERIALS SPECIFIED IN THE RISK REGISTER AND THERE IS NO NEED FOR FURTHER UPDATE BASED ON THE CLINICAL ASSESSMENT, AND RISK REGISTER INFORMATION THE CASE IS CONSIDERED REPORTABLE. THE DEVICE IS PENDING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S REFERENCE NUMBER: (B)(4): CLINICAL EVALUATION OF THE EVENT: END USER IS CURRENTLY EXPERIENCING DRAINAGE AND REDNESS AND PAIN IN BOTH EARS THAT IS CURRENTLY BEING TREATED WITH ANTIBIOTICS. THE HCP IS RECOMMENDING THAT THE END USER STOP WEARING THE DEVICE FOR A WEEK AND IS RECOMMENDING A DEVICE WITH MORE VENTILATION. IT APPEARS THAT THE DEVICES THEMSELVES ARE NOT CAUSING THE INFECTION, BUT, INSTEAD THAT THE AIR IS NOT PROPERLY VENTED BASED ON THE REQUIREMENTS FOR THE END USER. CLINICAL CONCLUSION IS THAT THE HEARING AIDS MAY BE CONTRIBUTING TO THE INFECTION, BUT NOT CAUSING THE INFECTION FROM A BIOCOMPATIBILITY STANDPOINT. CLINICAL EVALUATION ACCORDING TO 0378040 CLIN EVAL PLAN&RPT,HA&TSG: AS HEARING AIDS ARE DESIGNED TO HAVE SKIN CONTACT, THE MATERIAL USED IS BIOCOMPATIBLE AND A BIOLOGICAL EVALUATED ACCORDING TO PROCEDURE #(B)(4) CORP PROC,BIOL EVALUATION. HEARING AIDS ARE TYPICALLY BEING WORN MANY HOURS PER DAY AND IT IS NOT UNCOMMON THAT THE SKIN CONTACT CAN CAUSE MINOR SKIN IRRITATION. HOWEVER, MANY USERS GET ACCUSTOMED TO THE MATERIAL AND THE ITCHING OR IRRITATION. IN RARE CASES, A REACTION CAN DEVELOP. IN SOME CASES, TREATMENT WITH TOPICAL STEROID AND/OR ANTIBIOTICS WILL BE NECESSARY TO STOP THE SKIN IRRITATION. A TEMPORARY PAUSE IN THE HEARING AID USE, OR MODIFICATION TO THE HEARING AID SHAPE BY THE HEARING CARE PROFESSIONAL, IS ALSO RECOMMENDED TO HELP THE HEALING PROCESS. THE USER GUIDE INCLUDES A CAUTION TO CONSULT THE HEARING CARE PROFESSIONAL IF IRRITATION SHOULD OCCUR. IN THIS CASE, BOTH THE HCP AND A PCP HAS BEEN CONSULTED. THERE ARE NO NEW CLINICAL ASPECTS (E.G. UNFORESEEN USE OR CLINICAL CONDITIONS) DISCOVERED FROM THIS EVENT. THEREFORE, IT IS CONCLUDED THAT THE CURRENT CLINICAL EVALUATION AND RISK/BENEFIT CONCLUSIONS HEREIN ARE SUFFICIENT. RISK REGISTER REFERENCE: (B)(4) GEN BTE & ITE RISK ANALYSIS RISK ID U.1-8A FAIL TO IDENTIFY HYPER-SENSITIVITY. THE SPECIFIED ABOVE RISK OF HYPER-SENSITIVITY TO MATERIALS SPECIFIED IN THE RISK REGISTER AND THERE IS NO NEED FOR FURTHER UPDATE BASED ON THE CLINICAL ASSESSMENT, AND RISK REGISTER INFORMATION THE CASE IS CONSIDERED REPORTABLE. ADDITIONAL INFORMATION: DHR HAS BEEN REVIEWED AND NO FINDINGS REPORTED. VISUAL INSPECTION REVEALS CERUMEN AROUND THE BATTERY DOORS AND MINIMAL DEBRIS IN THE VENTS. SOME MOISTURE HAS BEEN NOTED IN THE RECEIVER WIRES. LISTENING CHECK REVEALS GOOD VOLUME AND SOUND QUALITY. NO FURTHER INVESTIGATIONS WILL BE PERFORMED. THE PATIENT HAS RECEIVED NEW DEVICE. THIS IS A FINAL REPORT.

    Description of Event or Problem · 0

    COURTESY REMAKE - PATIENT IS HAVING A LOT OF EAR INFECTIONS, CHANGING TO IROS VENTS. SNS (B)(4). THE PATIENT HAS REPORTED FOLLOWING SYMPTOMS: REDNESS, PAIN, INFECTION, EAR DISCHARGE/FLUID IN THE EAR CANAL. THE REACTION IS PRESENT IN BOTH EARS. IT IS NOT A RECURRING PROBLEM. THE REACTION IS RELATED TO THE PHYSICAL FIT OF THE HEARING AID AND NEEDED LARGER VENTS FOR DRAINAGE. IT HAS DEVELOPED SLOWLY OVER A FEW WEEKS. PRIMARY CARE PHYSICIAN PRESCRIBED ANTIBIOTICS. THE MEDICAL DOCTOR RECOMMENDATION- STOP WEARING DEVICES FOR A WEEK WHILE THE ANTIBIOTICS TOOK EFFECT AND SWITCHING TO DEVICES WITH MORE VENTING. PATIENT DID NOT REPORT ANY KNOWN HISTORY OF ALLERGIES, HYPERSENSITIVITY, FUNGAL INFECTIONS OR IF THE MEDICAL PROFESSIONAL PERFORMED A SWAP FOR BACTERIA AND FUNGI.

    Description of Event or Problem · 0

    COURTESY REMAKE - PATIENT IS HAVING A LOT OF EAR INFECTIONS, CHANGING TO IROS VENTS. SNS (B)(6). THE PATIENT HAS REPORTED FOLLOWING SYMPTOMS: REDNESS, PAIN, INFECTION, EAR DISCHARGE/FLUID IN THE EAR CANAL. THE REACTION IS PRESENT IN BOTH EARS. IT IS NOT A RECURRING PROBLEM. THE REACTION IS RELATED TO THE PHYSICAL FIT OF THE HEARING AID AND NEEDED LARGER VENTS FOR DRAINAGE. IT HAS DEVELOPED SLOWLY OVER A FEW WEEKS. PRIMARY CARE PHYSICIAN PRESCRIBED ANTIBIOTICS. THE MEDICAL DOCTOR RECOMMENDATION- STOP WEARING DEVICES FOR A WEEK WHILE THE ANTIBIOTICS TOOK EFFECT AND SWITCHING TO DEVICES WITH MORE VENTING. PATIENT DID NOT REPORT ANY KNOWN HISTORY OF ALLERGIES, HYPERSENSITIVITY, FUNGAL INFECTIONS OR IF THE MEDICAL PROFESSIONAL PERFORMED A SWAP FOR BACTERIA AND FUNGI. FOLLOW UP RECEIVED ON 27JUN2022: ON 5/18/22 PATIENT CONFIRMED THAT THE DOCTOR DIAGNOSED WITH EAR INFECTION AND TOLD THE PATIENT TO WAIT TO WEAR DEVICE UNTIL THE INFECTION CLEARED UP. THE PATIENT WAS PRESCRIBED ANTIBIOTICS. PATIENT DID NOT WANT TO SHARE MEDICAL HISTORY. THESE ARE THE ONLY HEARING AIDS PATIENT HAS EVER WORN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318336 GN RESOUND HEARING AID, AIR CONDUCTION WITH WIRELESS TECHNOLOGY OSM GN HEARING A/S PRODUCT RE9MIH-W-UP,LINX QUATTRO 9,GN RESOUND UNKNOWN 05708296174898

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention