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

Model Number	RT9ITC-DWC-HP
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's ref# (b)(4) manufacturer's investigation: technical investigation concluded: a dhr review have been completed.No deviation or changes were found during manufacturing of the device.The device met specification before shipment clinical conclusion: it has been reported that an in-the-canal hearing aid cracked for the second time.There is no allegation of harm in the case.Despite attempts, it has not been possible to gather further information on the case.Investigation of the actual device showed that the crack sits on the part of the hearing aid which is inside the ear canal, and is held together by a rubber tube.The formation of the crack is due to external force being applied to the shell, creating a bending moment, which caused internal stresses to build up in the shell and forming the crack.A dhr review have been completed.No deviation or changes were found during manufacturing of the device.The device met specification before shipment.Clinical conclusion on the case is that there was no harm to the user.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: this is a generally known risk, mitigations are in place.The risk is considered to be of an acceptable nature.Device investigation concluded: an itc hearing aid was returned due to it having formed a large crack which detached the tip of the hearing.The tip could easily detach from the hearing aid if it were to be worn, which would pose a threat to the patient due.The edges of the crack are very sharp which could irritation and in worse scenarios cut the inside ear, forming wounds.The formation of the crack is due to external force being applied to the shell, creating a bending moment, which caused internal stresses to build up in the shell and forming the crack.The shell thickness is barely within specifications if you account for measurement inaccuracies.Thickening of the shell could make the hearing aid more resistant towards drop and rough handling.Manufacturer's investigation is final.This is a combined (initial and final) report.
Event or Problem Description
Estimated date of incident (b)(6) 2023 it was reported that the user's in-the-ear hearing aid had cracked for the second time.Date of awareness: 04th jan 2024: on 04jan2024 the device was received back by manufacturer, and it became apparent that the break on the hearing aid was inside the ear canal, and therefore could lead to a serious injury, if the user were to continue wearing the device.No harm to the user or property has been reported.No further follow up is available.

• 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: 18621574
• Report Number: 3005650109-2024-00001
• Device Sequence Number: 2405903
• Product Code: OSM
• UDI-Device Identifier: 05708296217861
• UDI-Public: 05708296217861
• Combination Product (Y/N): N
• 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): 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: RT9ITC-DWC-HP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2023
• Initial Report FDA Received Date: 02/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2023
• 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
• Patient Sex: Unknown