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

Model Number	RE9ITC-DWT-UP
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	05/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's ref# (b)(4).Manufacturer's investigation is ongoing.A final report will be submitted upon completion of the investigation this is an initial report.
Event or Problem Description
It was reported that a hearing aid broke inside the user's ear.The faceplate came off of the hearing aid, and subsequent attempts to remove the rest of the device caused damage to the shell and the ear canal.The device was removed by the wife of the user.User did not seek medical attention following the incident.Further follow up is expected.
Additional Manufacturer Narrative
Manufacturer's ref# sf (b)(4).Manufacturer's investigation is ongoing.A final report will be submitted upon completion of the investigation this is an initial report.09jul2025: manufacturers investigation concluded: technical investigation concluded: device history record (dhr) review have been completed.No deviation or changes were found during manufacturing of the device.The clinical investigation concluded: it has been reported that the faceplate came off of an in the ear hearing aid, and that subsequent attempts to remove it cause damage to the shell and the ear canal of the user.It was the user's wife who removed the device from the ear.There were no issues with the device leading up to this incident, and a dhr review have been completed.No deviation or changes were found during manufacturing of the device.Clinical conclusion is that the incident did not cause any major harm to the user, but rather a minor laceration in the ear canal.Despite testing against requirements for construction, there is still risk that a hearing aid may be damaged and potentially broken due to unexpected external mechanical force beyond typical use.Should a hearing aid break due to mechanical force, there is a possibility that the damage results in the creation of exposed sharp edges.These sharp edges could potentially cause harm in the ear canal, likely only superficial in nature.If the hearing aid is accidentally dropped to the floor and then cracked or shattered into pieces, it is evaluated as very unlikely that the users may get harmed due to sharp corners and edges as the damage itself is obvious to the users.It is evaluated as highly unlikely that the hearing aid would break in the ear unless force from an external source is present when considering the shell thickness of the hearing aid.Further, the user guide includes a caution not to use a broken hearing aid.Risk assessment: the residual risk after the risk control measure(s) is acceptable.No new hazardous situations revealed and no need to update the risk register device investigation concluded: device repair completed on (b)(6) 2024.This repair did not require the replacement of the original shell built during the device manufacturing.The device history record and electro acoustic (ea) test corresponding to this repair have been reviewed and attached to the case.No deviation from specified requirements or process change has been identified.The visual inspection and measure of the device has confirmed that the shell thickness (shell material + lacquer) ranges between 1,09 and 1,23 mm (several - (b)(4) - measures taken on different positions).Information in the system about the initial e-sculpting has also shown that the shell wall thickness was above specification (0,6 mm).None of these measures support the possibility that an excessively thin shell wall might have caused the issue described in this complaint.Manufacturers investigation is final.This is a final report.
Event or Problem Description
It was reported that a hearing aid broke inside the user's ear.The faceplate came off of the hearing aid, and subsequent attempts to remove the rest of the device caused damage to the shell and the ear canal.The device was removed by the wife of the user.User did not seek medical attention following the incident.Further follow up is expected.On 09jul2025: no further follow up is available or expected.

• 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: 22343830
• Report Number: 3005650109-2025-00020
• Device Sequence Number: 15585245
• Product Code: OSM
• UDI-Device Identifier: 05708296188017
• UDI-Public: 05708296188017
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Followup
• Report Date (Section B): 07/09/2025

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: RE9ITC-DWT-UP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2025
• Supplement Date Received by Manufacturer: 05/28/2025
• Initial Report FDA Received Date: 06/27/2025
• Supplement Report FDA Received Date: 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/26/2023
• 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: Male