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

Model Number	KE3ITC-DW-MP
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's reference number (b)(4).Technical investigation concluded: a dhr review have been completed.No deviation or changes were found during manufacturing of the device.Clinical assessment: clinical evaluation of the event: it was reported that there was a broken wax buster in the hearing aid and that it broke when wiping the device over to clean it.Upon review of the received information it was determined that the wax buster most likely broke due to the wiping of the device and that there was no manufacturing issues related to the break.The item did not require removal and it did not cause harm to the user.No medical attention was sought.This is not a recurring issue for the user.The clinical conclusion is that the event did not cause harm to the user.Clinical evaluation according to clin eval plan&rpt, ha&tsg and clin eval plan&rpt, other acc: hearing aids need to have detachable spare parts as wax filters.Therefore, eliminating the risk of a spare parts remaining in the ear canal is not possible.A wax filter can become detached and remain in the user's ear canal when the hearing aid is removed or if the cerustop bushing has become dislodged from excessive force applied during replacements or cleaning of the wax filter.Without bushing, a replaced cerustop is not secure and may fall out in the ear.The wax filter then constitutes a foreign body in the ear canal and should be removed as soon as possible as it can pose an infection risk.The hazard is identified in the risk analysis and mitigated on device design by ensuring that the wax filter cannot be removed without a tool.The user guide includes an instruction on how to replace a wax filter with a tool and to contact the hcp if a foreign object is located in the ear canal.Risk assessment: precise circumstances surrounding the issue are unknown.Risks related to mechanical damage are generally known, considered in the risk analysis, mitigated and communicated to the user.This risk is deemed to be acceptable.Manufacturer's investigation is final.This is a combined (initial and final) report.
Event or Problem Description
Manufacturer's reference number (b)(4).It was reported that the wax buster fell off a hearing aid while the user was wiping it over to clean.The object did not require removal and the event has not caused harm.No further follow up is 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: 20577300
• Report Number: 3005650109-2024-00095
• Device Sequence Number: 15615854
• Product Code: OSM
• UDI-Device Identifier: 05708296207527
• UDI-Public: 05708296207527
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 10/30/2024

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
• Device Model Number: KE3ITC-DW-MP
• 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: 10/01/2024
• Initial Report FDA Received Date: 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/25/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Sex: Male