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

Model Number	KE3ITE-DW-UP
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2024
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
Estimated date of incident (b)(6) 2024 it was reported that the shell broken in two.No harm to the user has been reported.Further follow up is requested.
Event or Problem Description
Estimated date of incident jan2024 it was reported that the shell broken in two.No harm to the user has been reported.Further follow up is requested.11apr2024: date of incident 13feb2024 it was confirmed that no harm or injury was caused to the user.Hearing care provider requested a remake of the earmolds.No further information expected.
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.09april2024 manufacturer's investigation: 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: it was reported that right in-the-ear custom made hearing aid shell is broken in two.It has been confirmed that the client is not injured.Hearing care professional order a remake of the molds.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 assessment conclusion: risks related to such mechanical damage are generally known, considered in the risk analysis, mitigated, communicated to the user and as such deemed to be of an acceptable nature.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: 18910460
• Report Number: 3005650109-2024-00026
• Device Sequence Number: 15210627
• Product Code: OSM
• UDI-Device Identifier: 05708296207565
• UDI-Public: 05708296207565
• 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): 04/11/2024

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: KE3ITE-DW-UP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2024
• Supplement Date Received by Manufacturer: 02/14/2024
• Initial Report FDA Received Date: 03/15/2024
• Supplement Report FDA Received Date: 04/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/31/2023
• 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 Age: 85 YR
• Patient Sex: Male