GN RESOUND
Report
- Report Number
- 3005650109-2025-00004
- Event Type
- Malfunction
- Date Received
- February 14, 2025
- Date of Event
- January 29, 2025
- Report Date
- March 4, 2025
- Manufacturer
- GN HEARING A/S
- Product Code
- OSM
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
MANUFACTURER'S REF#: (B)(4). TECHNICAL INVESTIGATION CONCLUDED: DEVICE WAS NOT MANUFACTURED BY GN, AND ADDITIONALLY IT WAS DISCARDED WITH NO SERIAL NUMBER AVAILABLE. NO DHR CHECK HAS BEEN POSSIBLE. THE CLINICAL INVESTIGATION CONCLUDED: IT HAS BEEN REPORTED THAT A VARTA NON-RECHARGEABLE BATTERY HAS ALLEGEDLY EXPLODED INSIDE A GN HEARING AID. THE BATTERY WAS CORRECTLY INSERTED INTO THE HEARING AID WHEN THE INCIDENT HAPPENED. THE HEARING AID WAS SITTING BEHIND THE USER'S RIGHT EAR AT THE TIME OF THE INCIDENT, AND THE USER WAS SHOCKED AND THE DEVICE BECAME WARM SUDDENLY. THERE WAS NO WOUND RESULTING FROM THE INCIDENT AND NO OTHER HARM HAS BEEN REPORTED. THE BATTERY HAS SINCE BEEN DISCARDED BEFORE BEING RETURNED TO GN, AND THEREFORE IT IS NOT POSSIBLE TO CONFIRM THE ALLEGATION OF THE EXPLODED BATTERY. PICTURES OF THE INVOLVED BATTERY SHOW THAT IT HAS EXPANDED. CLINICAL CONCLUSION ON THE CASE IS THAT IT HAS NOT CAUSED ANY HARM TO THE USER. LEAKAGE FROM BATTERIES CAN RESULT FROM BATTERY EXPLOSION OR THE BATTERY CAN HAVE A HOLE THAT ALLOWS MATERIAL TO LEAK OUT. ZINC-AIR AND SILVER ZINC BATTERIES USED WITH HEARING AIDS ARE KNOWN TO HAVE A LOW RISK OF LEAKING AND "EXPLODING". ZINC-AIR BATTERIES ARE USED IN THE NON-RECHARGEABLE HEARING AIDS AND SILVER ZINC BATTERIES ARE USED IN THE Z-POWER SOLUTION. THE RISK INCREASES IF THE BATTERY IS EXPOSED TO EXCESSIVE HEAT. EVEN WITHOUT EXCESSIVE HEAT, IN RARE CASES, GAS CAN BE GENERATED INSIDE THE BATTERY AND IF THE PRESSURE BUILDS UP TO MORE THAN THE CELL CAN WITHSTAND, A RUPTURE CAN OCCUR. ALL MATERIALS SHOULD BE PUT IN A CONTAINER AND CARE SHOULD BE TAKEN TO AVOID SKIN BEING EXPOSED TO RUPTURED BATTERY. IF SKIN IS EXPOSED, IT SHOULD BE FLUSHED WITH LUKEWARM WATER FOR AT LEAST 15 MINUTES. IMMEDIATE MEDICAL ATTENTION SHOULD BE SOUGHT IF EYES ARE EXPOSED. BATTERY LEAKAGE CAN IN SOME CASES BE PREVENTED IF THE HEARING AIDS ARE DRIED OUT AFTER USE BY OPENING THE BATTERY DOOR. FURTHER, BATTERIES THAT ARE EXPIRED ARE MORE LIKELY TO LEAK. THE USER GUIDE INCLUDES RECOMMENDATIONS ON BOTH HEARING AID DRYING AND ONLY TO USE BATTERIES WITH A REMAINING SHELF LIFE OF ONE YEAR OR MORE. THE USER GUIDE CONTAINS INFORMATION ONLY TO USE QUALITY BATTERIES AS WELL AS RINSING WITH LUKEWARM WATER IF EXPOSED TO BATTERY LEAKAGE. IF A BATTERY OR A HEARING AID IS ACCIDENTLY INGESTED, AN IMMEDIATE EMERGENCY APPOINTMENT SHOULD BE MADE. RISK REGISTER REFERENCE: RISKS RELATED TO ELECTRICAL ENERGY, ARE GENERALLY KNOWN, CONSIDERED IN RISK ANALYSIS, MITIGATED AND COMMUNICATED TO THE USER. THIS RISK IS DEEMED TO BE ACCEPTABLE. MANUFACTURER'S INVESTIGATION IS FINAL. THIS IS A COMBINED (INITIAL AND FINAL) REPORT.
MANUFACTURER'S REF# (B)(4). 03APR2025: FURTHER INFORMATION RECEIVED. THE CLINICAL INVESTIGATION CONCLUDED: IT HAS BEEN REPORTED THAT A VARTA NON-RECHARGEABLE BATTERY HAS ALLEGEDLY EXPLODED INSIDE A GN HEARING AID. THE BATTERY WAS CORRECTLY INSERTED INTO THE HEARING AID WHEN THE INCIDENT HAPPENED. THE HEARING AID WAS SITTING BEHIND THE USER'S RIGHT EAR AT THE TIME OF THE INCIDENT, AND THE USER WAS SHOCKED AND THE DEVICE BECAME WARM SUDDENLY. TWO MONTHS AFTER THE INCIDENT, THE USER HAS REPORTED THAT HE NOW HAS SEVERE TINNITUS ON THE RIGHT EAR AND REDUCED HEARING. NO COMPLAINTS ON THE LEFT EAR. USER HAS SEEN AN ENT 2 MONTHS AFTER THE INCIDENT, WHERE THE EAR AND MASTOID WAS NORMAL, NO SWELLING VISIBLE AROUND THE EAR AND AN INTACT EARDRUM, AND NORMAL MIDDLE EAR CONDITIONS, THERE WAS NO PAIN IN THE EAR AND NO BURNS. SPEECH RECOGNITION ON THE RIGHT EAR WAS 55% AT 90 DB, LEFT EAR HAS NORMAL SPEECH RECOGNITION AT 100%. THE NEWEST CONDUCTED SPEECH RECOGNITION TEST BEFORE THIS INCIDENT WAS IN 2024, WHERE SPEECH RECOGNITION ON THE RIGHT SIDE WAS 90% AT 90 DB. IN 2019 A SPEECH RECOGNITION TEST WAS ALSO CONDUCTED, AT THIS TIME HE HAD A SPEECH RECOGNITION OF 100% AT 90 DB ON THE RIGHT EAR. THE PURE TONE AUDIOMETRY PART OF THE HEARING TEST SHOWS A SLIGHT OVERALL WORSENING IN HEARING FROM 2019 TO 2024 WITH THE LARGEST DECLINE IN HEARING ON THE RIGHT SIDE BEING 10 DB AT 250 HZ. BETWEEN 2024 AND 2025 (AFTER THE INCIDENT) THE PURE TONE AUDIOMETRY SHOWS AN OVERALL SLIGHT DECLINE. THERE WAS NO CHANGE AT 250 HZ, AT 500 HZ THE HEARING IMPROVED BY 10 DB, AND AT 1-3K HZ IT WORSENED BY 10 DB, AND AT 8K HZ IT WORSENED BY 15 DB. PURE TONE AUDIOMETRY HAS A TEST-RETEST VALIDITY OF 5-10 DB, SO AN IMPROVEMENT OR DECLINE OF ANYTHING ABOVE/BELOW 10 DB MAY BE DISREGARDED. THEREFORE, IT CANNOT BE CONCLUDED THAT THE USER HAS HAD AN ACTUAL DECLINE IN HEARING SINCE THE INCIDENT, AND ANY POTENTIAL DECLINE CANNOT BE PROVEN TO BE DUE TO THE INCIDENT. THE HEARING TEST PRESENTS AS A FLAT-TO-SLOPING AUDIOGRAM. THIS IS INDICATIVE OF A PRESBYCUSIS CASE, MEANING AN AGE-RELATED HEARING LOSS, IN WHICH THE HEARING WILL SUDDENLY SLOPE DOWN AT THE HIGHER FREQUENCIES. A NOISE INDUCED HEARING LOSS IS CHARACTERISED BY A SUDDEN DROP DOWN AT 4K HZ, FOLLOWED BY AN IMPROVEMENT IN HEARING LEVEL AT 8K HZ. THERE IS NO INDICATION OF THIS IN ANY OF THE USER'S AUDIOGRAM, HENCE IT IS UNLIKELY THAT HIS HEARING LOSS COULD BE DUE TO ANY LOUD SOUND RELATED ISSUES. THE ENT HAS NOT PRESCRIBED ANY MEDICAL INTERVENTION TO THE USER. THE BATTERY HAS SINCE BEEN DISCARDED BEFORE BEING RETURNED TO GN, AND THEREFORE IT IS NOT POSSIBLE TO CONFIRM THE ALLEGATION OF THE EXPLODED BATTERY. PICTURES OF THE INVOLVED BATTERY SHOW THAT IT HAS EXPANDED AND THE HEARING AID EXPANDED SLIGHTLY WITH IT. CLINICAL CONCLUSION ON THE CASE IS THAT IT IS UNLIKELY THAT THE DEVICE HAS RUPTURED THE USER'S EARDRUM OR THAT HIS HEARING HAS BEEN AFFECTED BY ANY LOUD SOUND OCCURRING FROM THE INCIDENT. IT IS UNEXPLAINED THE REASON FOR THE TINNITUS AND WORSENING IN SPEECH RECOGNITION, AND IT IS UNLIKELY THAT THERE IS A CAUSAL RELATIONSHIP BASED ON THE ABOVE INFORMATION. CLINICAL EVALUATION ACCORDING TO CLINICAL EVALUATION PLAN AND REPORT: THE CLINICAL EVALUATION FOR THE DEVICE FAMILY DOES EVALUATE LOUD SOUNDS AND THIS IS ADDRESSED IN THE RISK ANALYSIS AND MITIGATED TO AN ACCEPTABLE LIMIT BY BUILT-IN PROTECTIVE MEASURES IN THE DEVICE DESIGN. THE CLINICAL EVALUATION FOR THE DEVICE FAMILY DOES EVALUATE TINNITUS AS A RARE SIDE EFFECT OF HEARING AID USE. 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. LEAKAGE FROM BATTERIES CAN RESULT FROM BATTERY EXPLOSION OR THE BATTERY CAN HAVE A HOLE THAT ALLOWS MATERIAL TO LEAK OUT. ZINC-AIR AND SILVER ZINC BATTERIES USED WITH HEARING AIDS ARE KNOWN TO HAVE A LOW RISK OF LEAKING AND "EXPLODING". ZINC-AIR BATTERIES ARE USED IN THE NON-RECHARGEABLE HEARING AIDS AND SILVER ZINC BATTERIES ARE USED IN THE Z-POWER SOLUTION. THE RISK INCREASES IF THE BATTERY IS EXPOSED TO EXCESSIVE HEAT. EVEN WITHOUT EXCESSIVE HEAT, IN RARE CASES, GAS CAN BE GENERATED INSIDE THE BATTERY AND IF THE PRESSURE BUILDS UP TO MORE THAN THE CELL CAN WITHSTAND, A RUPTURE CAN OCCUR. ALL MATERIALS SHOULD BE PUT IN A CONTAINER AND CARE SHOULD BE TAKEN TO AVOID SKIN BEING EXPOSED TO RUPTURED BATTERY. IF SKIN IS EXPOSED, IT SHOULD BE FLUSHED WITH LUKEWARM WATER FOR AT LEAST 15 MINUTES. IMMEDIATE MEDICAL ATTENTION SHOULD BE SOUGHT IF EYES ARE EXPOSED. BATTERY LEAKAGE CAN IN SOME CASES BE PREVENTED IF THE HEARING AIDS ARE DRIED OUT AFTER USE BY OPENING THE BATTERY DOOR. FURTHER, BATTERIES THAT ARE EXPIRED ARE MORE LIKELY TO LEAK. THE USER GUIDE INCLUDES RECOMMENDATIONS ON BOTH HEARING AID DRYING AND ONLY TO USE BATTERIES WITH A REMAINING SHELF LIFE OF ONE YEAR OR MORE. THE USER GUIDE CONTAINS INFORMATION ONLY TO USE QUALITY BATTERIES AS WELL AS RINSING WITH LUKEWARM WATER IF EXPOSED TO BATTERY LEAKAGE. IF A BATTERY OR A HEARING AID IS ACCIDENTLY INGESTED, AN IMMEDIATE EMERGENCY APPOINTMENT SHOULD BE MADE. RISK REGISTER REFERENCE: RISKS RELATED TO ELECTRICAL ENERGY, LOUD SOUND AND OTHER ARTIFACTS ARE GENERALLY KNOWN, CONSIDERED IN THE RISK ANALYSIS, MITIGATED, AND COMMUNICATED TO THE USER. THE RISK IS DEEMED TO BE OF ACCEPTABLE NATURE. MANUFACTURER'S INVESTIGATION IS FINAL. THIS IS A FINAL REPORT. 14FEB2025: TECHNICAL INVESTIGATION CONCLUDED: DEVICE WAS NOT MANUFACTURERED BY GN, AND ADDITIONALLY IT WAS DISCARDED WITH NO SERIAL NUMBER AVAILABLE. NO DHR CHECK HAS BEEN POSSIBLE. THE CLINICAL INVESTIGATION CONCLUDED: IT HAS BEEN REPORTED THAT A VARTA NON-RECHARGEABLE BATTERY HAS ALLEGEDLY EXPLODED INSIDE A GN HEARING AID. THE BATTERY WAS CORRECTLY INSERTED INTO THE HEARING AID WHEN THE INCIDENT HAPPENED. THE HEARING AID WAS SITTING BEHIND THE USER'S RIGHT EAR AT THE TIME OF THE INCIDENT, AND THE USER WAS SHOCKED AND THE DEVICE BECAME WARM SUDDENLY. THERE WAS NO WOUND RESULTING FROM THE INCIDENT AND NO OTHER HARM HAS BEEN REPORTED. THE BATTERY HAS SINCE BEEN DISCARDED BEFORE BEING RETURNED TO GN, AND THEREFORE IT IS NOT POSSIBLE TO CONFIRM THE ALLEGATION OF THE EXPLODED BATTERY. PICTURES OF THE INVOLVED BATTERY SHOW THAT IT HAS EXPANDED. CLINICAL CONCLUSION ON THE CASE IS THAT IT HAS NOT CAUSED ANY HARM TO THE USER. LEAKAGE FROM BATTERIES CAN RESULT FROM BATTERY EXPLOSION OR THE BATTERY CAN HAVE A HOLE THAT ALLOWS MATERIAL TO LEAK OUT. ZINC-AIR AND SILVER ZINC BATTERIES USED WITH HEARING AIDS ARE KNOWN TO HAVE A LOW RISK OF LEAKING AND "EXPLODING". ZINC-AIR BATTERIES ARE USED IN THE NON-RECHARGEABLE HEARING AIDS AND SILVER ZINC BATTERIES ARE USED IN THE Z-POWER SOLUTION. THE RISK INCREASES IF THE BATTERY IS EXPOSED TO EXCESSIVE HEAT. EVEN WITHOUT EXCESSIVE HEAT, IN RARE CASES, GAS CAN BE GENERATED INSIDE THE BATTERY AND IF THE PRESSURE BUILDS UP TO MORE THAN THE CELL CAN WITHSTAND, A RUPTURE CAN OCCUR. ALL MATERIALS SHOULD BE PUT IN A CONTAINER AND CARE SHOULD BE TAKEN TO AVOID SKIN BEING EXPOSED TO RUPTURED BATTERY. IF SKIN IS EXPOSED, IT SHOULD BE FLUSHED WITH LUKEWARM WATER FOR AT LEAST 15 MINUTES. IMMEDIATE MEDICAL ATTENTION SHOULD BE SOUGHT IF EYES ARE EXPOSED. BATTERY LEAKAGE CAN IN SOME CASES BE PREVENTED IF THE HEARING AIDS ARE DRIED OUT AFTER USE BY OPENING THE BATTERY DOOR. FURTHER, BATTERIES THAT ARE EXPIRED ARE MORE LIKELY TO LEAK. THE USER GUIDE INCLUDES RECOMMENDATIONS ON BOTH HEARING AID DRYING AND ONLY TO USE BATTERIES WITH A REMAINING SHELF LIFE OF ONE YEAR OR MORE. THE USER GUIDE CONTAINS INFORMATION ONLY TO USE QUALITY BATTERIES AS WELL AS RINSING WITH LUKEWARM WATER IF EXPOSED TO BATTERY LEAKAGE. IF A BATTERY OR A HEARING AID IS ACCIDENTLY INGESTED, AN IMMEDIATE EMERGENCY APPOINTMENT SHOULD BE MADE. RISK REGISTER REFERENCE: RISKS RELATED TO ELECTRICAL ENERGY, ARE GENERALLY KNOWN, CONSIDERED IN RISK ANALYSIS, MITIGATED AND COMMUNICATED TO THE USER. THIS RISK IS DEEMED TO BE ACCEPTABLE. MANUFACTURER'S INVESTIGATION IS FINAL. THIS IS A COMBINED (INITIAL AND FINAL) REPORT.
IT HAS BEEN REPORTED THAT A VARTA NON-RECHARGEABLE BATTERY HAS EXPLODED INSIDE A GN HEARING AID. THE HEARING AID WAS SITTING BEHIND THE USER'S RIGHT EAR AT THE TIME OF THE INCIDENT, AND THE USER WAS SHOCKED AND THE DEVICE BECAME WARM SUDDENLY. THERE WAS NO WOUND RESULTING FROM THE INCIDENT AND NO OTHER HARM HAS BEEN REPORTED. THE BATTERY HAS SINCE BEEN DISCARDED BEFORE BEING RETURNED TO GN. NO FURTHER FOLLOW UP IS EXPECTED.
03-APR-2025: MANUFACTURER WAS PROVIDED WITH ADDITIONAL INFORMATION. UPDATED DESCRIPTION IS AS FOLLOWS: IT HAS BEEN REPORTED THAT A VARTA NON-RECHARGEABLE BATTERY HAS ALLEGEDLY EXPLODED INSIDE A GN HEARING AID. THE BATTERY WAS CORRECTLY INSERTED INTO THE HEARING AID WHEN THE INCIDENT HAPPENED. THE HEARING AID WAS SITTING BEHIND THE USER'S RIGHT EAR AT THE TIME OF THE INCIDENT, AND THE USER WAS SHOCKED AND THE DEVICE BECAME WARM SUDDENLY. TWO MONTHS AFTER THE INCIDENT, THE USER HAS REPORTED THAT HE NOW HAS SEVERE TINNITUS ON THE RIGHT EAR AND REDUCED HEARING. NO COMPLAINTS ON THE LEFT EAR. USER HAS SEEN AN ENT 2 MONTHS AFTER THE INCIDENT, WHERE THE EAR AND MASTOID WAS NORMAL, NO SWELLING VISIBLE AROUND THE EAR AND AN INTACT EARDRUM, AND NORMAL MIDDLE EAR CONDITIONS, THERE WAS NO PAIN IN THE EAR AND NO BURNS. THE ENT HAS NOT PRESCRIBED ANY MEDICAL INTERVENTION TO THE USER. THE BATTERY HAS SINCE BEEN DISCARDED BEFORE BEING RETURNED TO GN, AND THEREFORE IT IS NOT POSSIBLE TO CONFIRM THE ALLEGATION OF THE EXPLODED BATTERY. PICTURES OF THE INVOLVED BATTERY SHOW THAT IT HAS EXPANDED AND THE HEARING AID EXPANDED SLIGHTLY WITH IT. 14-FEB-2025: IT HAS BEEN REPORTED THAT A VARTA NON-RECHARGEABLE BATTERY HAS EXPLODED INSIDE A GN HEARING AID. THE HEARING AID WAS SITTING BEHIND THE USER'S RIGHT EAR AT THE TIME OF THE INCIDENT, AND THE USER WAS SHOCKED AND THE DEVICE BECAME WARM SUDDENLY. THERE WAS NO WOUND RESULTING FROM THE INCIDENT AND NO OTHER HARM HAS BEEN REPORTED. THE BATTERY HAS SINCE BEEN DISCARDED BEFORE BEING RETURNED TO GN. NO FURTHER FOLLOW UP IS EXPECTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1461175 | GN RESOUND | HEARING AID, AIR CONDUCTION WITH WIRELESS TECHNOLOGY | OSM | GN HEARING A/S | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Male |