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

Model Number	21655000
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	10/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's ref# (b)(4).Manufacturer's investigation: technical investigation concluded: device history record review shows no deviation or changes during manufacturing of the device.Device investigation concluded: visual inspection confirms the following; the encased mold was received without a wax guard, and there is a fairly significant amount of wax in the receiver bore of the mold, brass ring is intact.Clinical conclusion: hearing care professional checked patients' ear to make sure the wax guard wasn't in the canal.No harm has been reported.Clinical evaluation according to clinical evaluation plan: 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: risks related to mechanical force 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
Date of incident around 18-oct-2024.It has been reported that the wax guard does not stay in place in an encased mold.Hearing care provider checked the user's ear and there was no object in ear.There has been no harm reported in the case.The user has not been in contact with an authorized medical professional.No further follow up is available.

• 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: 20692779
• Report Number: 3005650109-2024-00099
• Device Sequence Number: 7196815
• Product Code: OSM
• UDI-Device Identifier: 05708296213351
• UDI-Public: 05708296213351
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/08/2024

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
• Operator of Device: Lay User/Patient
• Device Model Number: 21655000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2024
• Initial Report FDA Received Date: 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/27/2024
• 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