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

Model Number	22982570
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	07/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It has been reported that a wax filter and a dome came off a receiver-in-ear hearing aid and became lodged in the user's left ear canal.The reason for the event was that either the dome, wax filter or both were not snapped on correctly.There were no harm or symptoms reported following the incident.No further follow up is available or expected.
Additional Manufacturer Narrative
Manufacturer's ref# (b)(4).Manufacturer's investigation: technical investigation concluded: no device history record review has been conducted, as there are no serial numbers available for the dome or wax filter.Clinical conclusion: it has been reported that a wax filter and a dome came off a receiver-in-ear hearing aid and became lodged in the user's left ear canal.The reason for the event was that either the dome, wax filter or both were not snapped on correctly.The receiver itself remained intact.The user was advised to seek help to have the dome and filter removed at urgent care or the emergency room.Despite attempts, it has not been possible to obtain information about whether this was done.There were no harm or symptoms reported following the incident.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.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.Additionally, skin reactions can occur if improper cleaning supplies are being used on the devices.Some cleaning and drying products contain alcohol and chemicals that can cause skin irritation or allergic reactions.In addition, the chemicals can damage the material, potentially resulting in a raw surface that can lead to skin irritation from a rash.As the devices are physically touching the ear/ear canal there are risks of infection in cases where there was contaminated handling often devices or improper cleaning, should a detachable portion of the hearing aid (e.G., dome, wax filter) become lodged in the ear canal, or as, above, a damaged device causing cuts/scratches to the ear resulting in infection.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 hearing care professional (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.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: 50249287
• Report Number: 3005650109-2026-00027
• Device Sequence Number: 18643999
• Product Code: OSM
• UDI-Device Identifier: 05708296320646
• UDI-Public: 05708296320646
• 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): 08/14/2026

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: 22982570
• 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: 07/16/2026
• Initial Report FDA Received Date: 08/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/02/2024
• 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: 65 YR
• Patient Sex: Female