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

Model Number	21655200
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	06/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a wax filter grommet fell out of an encased receiver.The grommet fell out while the end-user was handling the device, it is unknown what the user was doing with the device at the time of the event.The wax filter grommet fell off outside of the user's ear, and hence no harm resulted from the event.No further follow up is expected.
Additional Manufacturer Narrative
Manufacturer's ref# (b)(4).Manufacturer's investigation: technical investigation concluded: a device history record review have been completed.No deviation or changes were found during manufacturing of the device.Clinical conclusion: it was reported that the brass grommet holding the wax guard fell out of the earmould.Initially, it was stated that the brass grommet had fallen into the user's ear canal and came out on its own, without causing injury.However, follow-up information clarified that, although the brass grommet did fall out, it did not fall into the user's ear.The brass grommet fell out of the earmould while the user was handling it.There were no reports of harm, symptoms, or injury to the user.As no foreign object entered the user's ear, no medical attention was sought.The clinical conclusion is that the detached brass grommet did not fall into the user's ear and no harm to the user was reported.Risk assessment: the cause of the issue is unknown.The wax guard grommet may have come loose through mechanical impact or customer handling.No specific harm was reported.The risk is deemed to be acceptable.This is a final report.

• Brand Name: Unbranded
• 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: 50068614
• Report Number: 3005650109-2026-00023
• Device Sequence Number: 16024164
• Product Code: OSM
• UDI-Device Identifier: 05708296213375
• UDI-Public: 05708296213375
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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,Followup
• Report Date (Section B): 08/28/2026

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: 21655200
• 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: 06/29/2026
• Supplement Date Received by Manufacturer: 06/29/2026
• Initial Report FDA Received Date: 07/29/2026
• Supplement Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/19/2025
• 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
• Patient Sex: Male