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

Model Number	21655100
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the brass riffel that hold the cerustop filter, fell out of the new encase mold on a hearing aid.The riffel fell out when the hearing care professional was replacing the user's wax guard and was not in the ear of the user.The object did not require removal and no harm was reported.This is an initial report.Further information is expected.
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.This is an initial report.Investigation is still in progress.A final report will be submitted upon completion.

• 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: 50473170
• Report Number: 3005650109-2026-00032
• Device Sequence Number: 18685314
• Product Code: OSM
• UDI-Device Identifier: 05708296213368
• UDI-Public: 05708296213368
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 08/27/2026

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: Health Professional
• Device Model Number: 21655100
• 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: 07/28/2026
• Initial Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/04/2026
• 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 Sex: Male