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

Model Number	PZ8ITE-DW-MP
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's ref# (b)(4).Manufacturer's investigation: technical investigation concluded: device history record review has been completed.No deviation or changes were found during manufacturing of the device clinical conclusion: it has been reported that two wax filters were discovered in the user's ear canal, following the use of custom hearing aids.The hearing care professional (hcp) had done an otoscopy prior to conducting a hearing test on the user, during this otoscopy she discovered that he had two wax filters in his ear, that he was unaware of.The hcp advised him to see a physician to have these removed, but the user said he would remove them himself.When told that he should not remove them himself, he questioned why he should not, after which the hcp explained the risk of damage, the user suggested flushing them out, which the hcp explained would not be a good idea, due to the risk of the filters getting pushed further into the ear.The user then requested that the hcp removed it using impression material, which the hcp refused to do as it would have to be done without oto-blocks.Hcp explained the risk of this, after which the user was upset and threatened to sue the company.The user could not feel the filters, and the hcp allowed him to exit the clinic with them still in his ears.It is unknown if the user sought medical assistance to have the filters removed.Before the user left, the hcp asked him to demonstrate a filter change, and concluded that he changed filters on a side-angle, rather than straight, and therefore the wax filters do not sit correctly in his device.This could be a reason for the filters in his ears.A device history record (dhr) review have been completed.No deviation or changes were found during manufacturing of the device.The clinical conclusion on this case is that the detached wax filters have not caused harm to the user, and that the incident is most likely due to incorrect insertion of the filters into the devices, which is further supported by the dhr.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 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.Device investigation concluded: no investigation has been conducted, as the device was not returned to the manufacturer.Manufacturer's investigation is final.This is a combined (initial and final) report.
Event or Problem Description
Date of incident: 14apr2025 it has been reported that two wax filters were discovered by a hearing care professional (hcp) in the user's ear canal, following the use of custom in-the-ear hearing aids.Hcp advised the user to go to a physician to have the wax filters removed.The user refused and wanted to remove them himself.The user was strongly advised against removed the filters himself and advised to have a professional to remove the filters.The user could not feel the filters in the ear canal, and the hcp allowed the user to leave the clinic with them still in his ears.It is unknown if the user sought medical assistance to have the filters removed.It has been reported that the detached wax filters have not caused harm to the user.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: 22033895
• Report Number: 3005650109-2025-00017
• Device Sequence Number: 9504638
• Product Code: OSM
• UDI-Device Identifier: 05708296190584
• UDI-Public: 05708296190584
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 05/16/2025

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: PZ8ITE-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: 04/16/2025
• Initial Report FDA Received Date: 05/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/20/2024
• 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