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

Model Number	22339574
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	01/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It is reported that user experienced itching in the ear canal for both ears, watery eyes and a suffocating feeling in the throat.The skin reaction has been confirmed by doctor but it is unknown if any medication has been prescribed.No further follow up is available or expected.
Additional Manufacturer Narrative
Manufacturer's ref# (b)(4).Manufacturer's investigation: technical investigation concluded: device history record review have been completed.No deviation or changes were found during manufacturing of the device.Clinical conclusion: it is reported that user experienced an alleged allergic reaction.The user has been wearing the hearing aids since the (b)(6) 2026 and the date of the incident was reported on the 26th of january 2026.In the past the user also experienced a reaction when the user started wearing new dental prothesis, at this time she experienced watery eyes and a feeling of a closed throat.With the hearing aids she is experiencing a similar reaction, but the specific symptoms related to the hearing aids is has not been reported.The skin reaction has been confirmed by doctor but it is unknown if any medication has been prescribed.In the past when the user used medication she was "bothered by it" and it didn't help.According to the doctor the reaction is related to hydroxyethyl methacrylate and nickel sulphate allergy.However, the hcp later reported that neither hydroxyethyl methacrylate nor nickel sulphate are contained in any of the listed parts (receivers, domes, and sportslocks).Hearing aids are designed to have skin contact with the end user, the materials used in the hearing aids are biocompatible and a biological evaluated according to biological evaluation procedure.A generic material list has been provided.Materials used in gn hearing products.Clinical conclusion on the case is that the allergic reaction is most likely not caused by the use of hearing aids, as neither hydroxyethyl methacrylate nor nickel sulfate is used in the relevant receivers, domes, or sportslocks.However, based on the available information - including the doctor's observation of allergy in the ears - it cannot be ruled out that the hearing aids may have contributed to the reaction.Risk assessment: risks related to skin irritation / similar such symptoms as well as in conjunction with existing medical conditions are 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.

• 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: 24304108
• Report Number: 3005650109-2026-00001
• Device Sequence Number: 21252567
• Product Code: OSM
• UDI-Device Identifier: 05708296269297
• UDI-Public: 05708296269297
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 02/10/2026

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: 22339574
• 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: 01/26/2026
• Initial Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/30/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 80 YR
• Patient Sex: Female