MAUDE Adverse Event Report: GN HEARING A/S GN HEARING; HEARING AID, , AIR CONDUCTION WITH WIRELESS TECHNOLOGY

Model Number	23816800
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a user saw flames from her hearing aid charger.The hearing aids had been charging overnight, and in the morning the user noticed flames coming from the charger.The user hit the charger with a kleenex box to put it out, after which she unplugged the charger.The hearing aids were in the charger when the incident occured, the hearing aids reportedly work as expected.No harm occured to the user following the event.It was reported that some of the charger melted onto the rug below where the charger was sitting.No further follow up from the reporter received.20mar2026: no further follow up from the reporter received.
Additional Manufacturer Narrative
Manufacturer's ref# (b)(4).A device history record review have been completed.No deviation or changes were found during manufacturing of the device.The device is currently being investigated by an independent party.The results of this investigation will be submitted in a final report.This is a follow up report.Investigation is still in progress.A final report will be submitted upon completion.
Additional Manufacturer Narrative
Manufacturer's ref#: (b)(4).A device history record review have been completed.No deviation or changes were found during manufacturing of the device.The device is currently being investigated by an independent party.The results of this investigation will be submitted in a final report.This is an initial report.Investigation is still in progress.A final report will be submitted upon completion.
Event or Problem Description
It was reported that a user saw flames from her hearing aid charger.The hearing aids had been charging overnight, and in the morning the user noticed flames coming from the charger.The user hit the charger with a kleenex box to put it out, after which she unplugged the charger.The hearing aids were in the charger when the incident occured, the hearing aids reportedly work as expected.No harm occured to the user following the event.It was reported that some of the charger melted onto the rug below where the charger was sitting.No further follow up from the reporter received.
Event or Problem Description
It was reported that a user saw flames from her hearing aid charger.The hearing aids had been charging overnight, and in the morning the user noticed flames coming from the charger.The user hit the charger with a kleenex box to put it out, after which she unplugged the charger.The hearing aids were in the charger when the incident occured, the hearing aids reportedly work as expected.No harm occured to the user following the event.It was reported that some of the charger melted onto the rug below where the charger was sitting.No further follow up from the reporter received.20mar2026.No further follow up from the reporter received.17apr2026.No further follow up from the reporter received.
Additional Manufacturer Narrative
Manufacturer's ref# (b)(4).A device history record review have been completed.No deviation or changes were found during manufacturing of the device.The device is currently being investigated by an independent party.The results of this investigation will be submitted in a final report.17-apr-2026: the event is now under investigation through the internal corrective and preventive action (capa) process, and the root cause investigation is pending.A final report will be submitted upon completion of the capa.

• Brand Name: GN HEARING
• Common Device Name: HEARING AID, , AIR CONDUCTION WITH WIRELESS TECHNOLOGY
• Manufacturer (Section D): GN HEARING A/S; lautrupbjerg 7; ballerup, 2750 ; DA 2750
• Manufacturer Contact: akanksha roy ; lautrupbjerg 7; ballerup, 2750 ; DA 2750
• MDR Report Key: 24387361
• Report Number: 3005650109-2026-00002
• Device Sequence Number: 10518734
• Product Code: OSM
• UDI-Device Identifier: 05708296399567
• UDI-Public: 05708296399567
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/14/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 23816800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/20/2026
• Supplement Date Received by Manufacturer: 01/20/2026; 01/20/2026; 01/20/2026
• Initial Report FDA Received Date: 02/19/2026
• Supplement Report FDA Received Date: 03/20/2026; 04/17/2026; 07/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/31/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Sex: Female