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

Model Number	KE3ITC-DW-HP
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Estimated date of incident (b)(6) 2023.It was reported that the shell was broken on in-the-canal device.No harm to user was reported.Further follow up is expected.
Additional Manufacturer Narrative
Manufacturer's ref# (b)(4).A dhr review have been completed.No deviation or changes were found during manufacturing of the device.Follow up has been requested.This is a late report.Investigation is still in progress; a final report will be submitted upon completion.
Event or Problem Description
Estimated date of incident (b)(6) 2023 it was reported that the shell was broken on in-the-canal device.No harm to user was reported.Further follow up is expected.On (b)(6) 2024 l no follow up information received.
Additional Manufacturer Narrative
Manufacturer's ref# (b)(4).A dhr review have been completed.No deviation or changes were found during manufacturing of the device.Follow up has been requested.This is a late report.Investigation is still in progress; a final report will be submitted upon completion.(b)(6) 2024 manufacturer's investigation conclusion: technical investigation concluded: device history record review has been completed.No deviation or changes were found during manufacturing of the device.The clinical investigation concluded: clinical evaluation is that the event did not cause harm to the user.Clinical evaluation according to clinical evaluation plan: 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 register reference: the residual risk after the risk control measure(s) is acceptable.No new hazardous situations revealed and no need to update the risk register.The risk of broken devices is known.Risk controls are in place.Deemed acceptable.Device investigation concluded: the thickness of the shell is measured to be within configurations.An inspection of the surface along the crack shows no signs of any defects within the plastic.Custom made devices are prone to break/crack easier dues to external factors.Manufacturer's investigation is final.This is a final report.

• 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: 18710158
• Report Number: 3005650109-2024-00012
• Device Sequence Number: 7084307
• Product Code: OSM
• UDI-Device Identifier: 05708296207510
• UDI-Public: 05708296207510
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 03/13/2024

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: KE3ITC-DW-HP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2023
• Supplement Date Received by Manufacturer: 12/18/2023
• Initial Report FDA Received Date: 02/15/2024
• Supplement Report FDA Received Date: 03/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/26/2021
• 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