MAUDE Adverse Event Report: GN Hearing A/S RESOUND; Hearing Aid, , Air Conduction With Wireless Technology

Model Number	23304473
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Skin Burning Sensation (4540)
Date of Event	07/01/2026
Type of Reportable Event	Malfunction

• Brand Name: RESOUND
• 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: 50171198
• Report Number: 3005650109-2026-00025
• Device Sequence Number: 8242856
• Product Code: OSM
• UDI-Device Identifier: 05708296366385
• UDI-Public: 05708296366385
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/07/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 23304473
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 07/09/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2026
• Initial Report FDA Received Date: 08/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/18/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown