MAUDE Adverse Event Report: GN Hearing A/S GN Hearing; Hearing Aid, Air Conduction With Wireless Technology

Model Number	23685474
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Ear infection (4813)
Date of Event	08/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Date of incident (b)(6) 2026.It was reported that the user developed a severe ear infection in both ear canals after wearing the hearing aids for a few days.The user added that she has eczema in both ears and has had ear infections before.The user is being treated by her ear-nose-throat (ent) doctor but the specific treatment is unknown.No harm to the user has been reported.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 the user developed a severe ear infection in both ear canals after wearing the hearing aids for a few days.The user added that she has eczema in both ears and has had ear infections before.This is a recurring issue for the user, who has a known history of hypersensitivity and ear infections.The user is being treated by her ear-nose-throat (ent) doctor but the specific treatment is unknown.However, the user was advised not to wear aids.No additional symptoms were reported.Clinical conclusion on the case is that based on the available information, the hearing aids may have contributed to the event.Risk assessment: risks related to skin hypersentivity/infection are known, considered in risk analysis, mitigated and communicated to the user.This is a known risk associated with the use of such devices.It is deemed to be of an acceptable nature.Manufacturer's investigation is final.This is a combined (initial and final) report.

• Brand Name: GN Hearing
• 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: 50709950
• Report Number: 3005650109-2026-00035
• Device Sequence Number: 10640840
• Product Code: OSM
• UDI-Device Identifier: 05708296386253
• UDI-Public: 05708296386253
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/10/2026

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: 23685474
• 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: 08/14/2026
• Initial Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/15/2026
• 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: 50 YR
• Patient Sex: Female