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

Model Number	21385200
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	03/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It has been reported that a receiver broke while in the ear canal and got stuck.The user was able to remove it himself, and no harm resulted from the incident.No further follow up is expected.
Additional Manufacturer Narrative
Manufacturer's ref# :(b)(4).Manufacturer's investigation: technical investigation concluded: there is no rework / reject / repair or abnormality captured for this unit.This unit had been passed through the test prior to shipment with no abnormality before shipment.No deviation or changes were found during manufacturing of the device.Clinical conclusion: it has been reported that a sf3 receiver broke while in the ear canal and got stuck.The user was able to remove it himself, and no harm resulted from the incident and no need for medical attention.The user went to see his audiologist following the incident.Clinical conclusion is that the detached receiver has not caused harm to the patient and no medical treatment was prescribed.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 (b)(4).The user guide states to contact the hcp 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: risks related to objects getting stuck in the ear canal are generally known, considered in the risk analysis, mitigated and communicated to the user.The risk is deemed to be of an acceptable nature.Trended case device investigation findings: 1.Inadequate pfmea assessment on insufficient glue application.2.No mechanism to specify and control the glue application amount since this process is human driven with inconsistency 3.The exact bonding evaluation method is divert.The bonding shall be conducted between housing and receiver contact point.Not on front housing tip and receiver cable instead.Manufacturer's investigation is final.This is a combined (initial and final) report.

• 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: 21898146
• Report Number: 3005650109-2025-00012
• Device Sequence Number: 20880383
• Product Code: OSM
• UDI-Device Identifier: 05708296219407
• UDI-Public: 05708296219407
• 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): 04/16/2025

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: 21385200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2025
• Initial Report FDA Received Date: 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/15/2022
• 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: Male