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

Model Number	KE2ITC-DW-MP
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Erythema (1840); Fluid Discharge (2686); Skin Inflammation/ Irritation (4545); Ear Pain (4812)
Type of Reportable Event	Serious Injury
Event or Problem Description
On 25-aug-2022 it was reported that the patient on unknown date changed from custom hearing aid to receiver-in-canal hearing aid, because of infection in both ear canals.The patient experienced pain in the ear canal, when the hearing aids were in during the day, and because of the pain they were removed.At night the patient experienced drainage.Symptoms reported: redness, pain, inflammation and ear discharge/fluid.The patient has never experienced this before.Hearing aid are a year old and the pain was recent.No known history of allergies or hypersensitivity.On unknown date, the patient was in contact with a medical practioner, who concluded that the drainage was non-infectious, no wounds in the ear canal or concha bowl and no effusion, and recommended that the patient switched to a behind-the-ear hearing aid style or refit the custom devices and follow-up in 3 months.Pain is suspected to be related to the physical fit of the hearing aids.
Additional Manufacturer Narrative
Technical investigation: a device history register review have been completed.No deviation or changes were found during manufacturing of the device.Clinical evaluation of the event: as hearing aids are designed to have skin contact with the end user, the materials used in the hearing aids are biocompatible and a biological evaluated according to procedure #00066720 corp proc,biol evaluation.A generic material list is provided in #0332250 materials used in gn hearing products.Case information states that end user is experiencing an allergic reaction in the ear canals where the hearing instruments make contact with the skin.Clinical conclusion on the case is that the reaction was caused by use of the hearing aids and that changing devices or device material is appropriate.Clinical evaluation according to corp proc gen evaluation 0185290: allergic reaction is identified in the risk analysis and mitigated to an acceptable level through device design by compliance with standards for biocompatibility.Still allergic reactions can occur in rare cases.The clinical evaluation does evaluate allergic reactions and the user guide includes a safety notification instructing the hearing aid wearer to contact the hcp in case of skin irritation.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.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 based on the above information the case is considered reportable as the incident did lead to, or might have led to a serious injury if it recurred.This is a final report.This case is considered as a single incident and will be included in regular trending.No actions have been initiated based on this individual event.

• 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: karen frisk ; lautrupbjerg 7; ballerup, 2750 ; DA 2750
• MDR Report Key: 15461173
• Report Number: 3005650109-2022-00037
• Device Sequence Number: 11485960
• Product Code: OSM
• UDI-Device Identifier: 05708296207428
• UDI-Public: 05708296207428
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 09/21/2022

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: KE2ITC-DW-MP
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2022
• Initial Report FDA Received Date: 09/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2021
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female