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

Model Number	RT9ITE-DWC-MP
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Eczema (4547)
Date of Event	09/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer's ref# (b)(4).Technical investigation concluded: a device history record review have been completed.No deviation or changes were found during manufacturing of the device.The clinical investigation concluded: it was reported that the user on (b)(6) 2023 started to get irritation in her concha bowl in (b)(6) 2023.Symptoms included redness, pain, sores and inflammation on one ear.User is wearing same type of hearing aid of the other ear, but with no eczema at this time.The user has a history of eczema since 2020.The user has been wearing the hearing aids since (b)(6) 2022.This eczema flare up began in (b)(6) 2023.The user saw her general practitioner who referred her to her ear-nose-throat-doctor and this person referred her to a dermatologist.Official diagnosis from dermatologist is eczema.User has been treated with hydrocortisone, antifungal medication and steroid drops.The audiologist is unsure if she feels it is the hearing aid that is the cause.At this point, wearing the aid irritates the user's ear but she believes that could be due to something touching an already irritated area.It was recommended remaking the aid with clear shell, no coloring on the serial number and no final coating.Further intermittent hearing aid use one the affected side until the skin clears was also recommended.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.Clinical conclusion on the case is that it cannot be ruled out that the hearing aids have contributed to this reaction.However, the user has a confounding medical history of eczema.Clinical evaluation: 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.The user guide includes a caution to consult the hearing care professional if irritation should occur.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.These risks are reduced as far as possible and the probability of occurrence of these events is considered very low.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 conclusion herein are sufficient.Risk register conclusion reference: this is a known risk and is deemed to be acceptable.Manufacturer's investigation is final.This is a combined (initial and final) report.No further information is expected.
Event or Problem Description
Estimated date of incident 04-sep-2023.It was reported that the user on (b)(6)2023 started to get irritation in her concha bowl in (b)(6) 2023.Symptoms included redness, pain, sores and inflammation on one ear.User is wearing same type of hearing aid of the other ear, but with no eczema at this time.The user has a history of eczema since 2020.The user has been wearing the hearing aids since november of 2022.This eczema flare up began in (b)(6) 2023.The user saw her general practitioner who referred her to her ear-nose-throat-doctor and this person referred her to a dermatologist.Official diagnosis from dermatologist is eczema.User has been treated with hydrocortisone, antifungal medication and steroid drops.

• 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: 18519379
• Report Number: 3005650109-2024-00005
• Device Sequence Number: 18039212
• Product Code: OSM
• UDI-Device Identifier: 05708296217915
• UDI-Public: 05708296217915
• 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): 01/16/2024

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: RT9ITE-DWC-MP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2023
• Initial Report FDA Received Date: 01/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2022
• 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: 60 YR
• Patient Sex: Female