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

Model Number	21385800
Medical Device Problem Codes	Product Quality Problem (1506); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2025
Type of Reportable Event	Malfunction
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 has been reported that a receiver separated at the point where the red/blue part meets the grey part.It happened outside of the user's ear, and there was no harm following the event.Clinical conclusion is that the detached receiver has not caused harm to the patient.The clinical evaluation for the device family does evaluate receivers coming loose in the ear canal.This is identified in the risk analysis and mitigated through device design by ensuring a sufficient pull force (compliance with iec 60601-2-66).The user guide states to contact the hearing care provider if a foreign object or wax is located in the ear canal to reduce the potential risk of harm as far as possible.There are no new clinical aspects (e.G.Unforeseen use or clinical conditions) discovered from this event.Therefore, it is concluded that the current clinical evaluation and risk/benefit conclusions herein are sufficient.Risk assessment: ha-hw-d-us2-10: based on the info this is a known risk covered by capa: 0712 (acc to parent (b)(4).All resulting actions are contained within the capa which includes assessment of risks and associated updates.Trended case device investigation findings: adhesive failure mode is observed on failed devices.Adhesive to adherent interfaces detached from each other.Adhesive failure modes occur due to several factors such as inappropriate adhesive selection, pure surface preparation, and exposure to environmental factors.Assembly lines do not overlap totally but leave open gaps, creating pockets for ingress and retention of adhesion degrading media.Used adhesive technical sheet suggests avoiding adhesive usage in chlorinated environments - we have body contacts manufacturer's investigation is final.This is a combined (initial and final) report.
Event or Problem Description
Estimated date of incident on (b)(6) 2025.It has been reported that a receiver separated at the point where the red/blue part meets the grey part.It happened outside of the user's ear, and there was no harm following the event.No further follow up is available or expected.

• Brand Name: GN 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: 22335135
• Report Number: 3005650109-2025-00021
• Device Sequence Number: 21113785
• Product Code: OSM
• UDI-Device Identifier: 05708296219469
• UDI-Public: 05708296219469
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/23/2025

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: 21385800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2025
• Initial Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/29/2022
• 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: Unknown