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

Model Number	NX7CIC-MP
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It is reported that on the (b)(6) 2026, an in-the-ear (ite) device had entered the user's ear canal deeper than usual, although he was still able to remove it himself.However, the following day, the same event occurred, and the user was unable to remove the device on his own, requiring a visit to the hospital.The device was successfully removed at the hospital.No further follow up is available.
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 is reported that on the 17th of july, an in-the-ear (ite) device had entered the user's ear canal deeper than usual, although he was still able to remove it himself.However, the following day, the same event occurred, and the user was unable to remove the device on his own, requiring a visit to the hospital.At the hospital, the device was removed by doctors using medical tweezers.Bleeding was observed upon extraction of the hearing aid.The user has not been in contact with an authorized medical practitioner since the event, as he has recovered and the ear has not sustained any further damage.The hearing care professional (hcp) confirmed that the user has a history of two tympanoplasties during adolescence.Observation of the ear impression showed that the ear canal is wider than usual near the eardrum.The hcp recommended that the user refrain from wearing the hearing aid until the wounds have healed and requested a replacement hearing aid with a wider faceplate to prevent recurrence.Clinical conclusion on the case is that the hearing aid has contributed to this event.Risk assessment: risks related to objects or whole devices 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: the device has not been returned to the manufacturer, hence no investigation of the physical device has been conducted.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: 50223148
• Report Number: 3005650109-2026-00026
• Device Sequence Number: 20191839
• Product Code: OSM
• UDI-Device Identifier: 05708296335466
• UDI-Public: 05708296335466
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/12/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: NX7CIC-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: 07/28/2026
• Initial Report FDA Received Date: 08/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/08/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 59 YR
• Patient Sex: Male