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

Model Number	23685474
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	05/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's ref# (b)(4).Manufacturer's investigation: technical investigation concluded: it has not been possible to review the production records for this device, as no serial number is available for the affected dome.Clinical conclusion: it was reported that a user might have gotten a small sized dome stuck inside their ear, while testing it.Upon removal of the hearing aid from the ear, the dome was found to no longer be attached and it is presumed to be in the ear canal, however, this has not been confirmed.The user was recommended to seek medical assistance for dome removal.There is no further information on the incident, and no harm reported.The clinical evaluation for the device family does evaluate domes coming loose in the ear canal.This is identified in the risk analysis and mitigated through device design by ensuring a sufficient pull force.The user guide states to contact the hearing care professional (hcp) if a foreign object or wax is in the ear canal to reduce the potential risk of harm as far as possible.There are no new clinical aspects (e.G., unforeseen use or clinical conditions) discovered from this event.Therefore, it is concluded that the current clinical evaluation and risk/benefit conclusions herein are sufficient.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: the device has not been returned to the manufacturer, hence no investigation of the physical device has been conducted.It has not been possible to confirm whether this is a malfunction of the device.Manufacturer's investigation is final.This is a combined (initial and final) report.
Event or Problem Description
It was reported that a user might have gotten a small sized dome stuck inside their ear.Upon removal of the hearing aid from the ear, the dome was found to no longer be attached and it is presumed to be in the ear canal, however, this has not been confirmed.The user was advised to seek medical help to get the dome removed.There was an appointment with hearing care professional scheduled.The outcome is not reported.No harm was reported.Futher information on this incident is not available or expected.

• 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: 25370459
• Report Number: 3005650109-2026-00014
• Device Sequence Number: 21485265
• 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
• 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): 06/02/2026

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: 05/04/2026
• Initial Report FDA Received Date: 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 72 YR
• Patient Sex: Female