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

Model Number	22338175
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	08/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Estimated date of incident (b)(6) 2026.It was reported that when the user hears any loud noise, it sounds like a gun firing rapidly.A weekend it happened in the user's wood shop, and he cut his hand.Further follow up is expected.
Additional Manufacturer Narrative
Manufacturer's ref# (b)(4).Manufacturer's investigation: technical investigation concluded: a device history record (dhr) review have been completed.No deviation or changes were found during manufacturing of the device manufacturer's investigation is ongoing.A final report will be submitted upon completion of the investigation this is an initial report.

• 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: 50880994
• Report Number: 3005650109-2026-00038
• Device Sequence Number: 13217997
• Product Code: OSM
• UDI-Device Identifier: 05708296269211
• UDI-Public: 05708296269211
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 09/24/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 22338175
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/11/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male