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

Model Number	20295000
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Infectious Otitis Externa (4814)
Date of Event	08/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer's ref# (b)(4), technical investigation concluded: a device history record review has not been completed as the provided sn could not be found.The clinical investigation concluded: clinical evaluation of the event: it was reported that the user got diagnosed with otitis externa on 14aug2024 and was prescribed antibiotic drops (floxacin), dexamethasone drops, hydrocortisone cream and mupirocin ointment.Symptoms started as discomfort which gradually worsened and include pain, inflammation, irritation on the posterior aspect of the tragus and lateral canals of both ears.This is not a first time user and he has not experienced this issue before.No known history of allergies, hypersensitivities of fungal infections.The user was recommended to hear earmolds out of ears to help ears heal and a remake of earmolds to fit better and prevent issue.The user followed up with a medical professional but it is not known what the outcome of the appointment was.Clinical evaluation according to clin eval plan&rpt, other acc: earmolds may be made of acrylic or soft silicone material.As earmolds are designed to have skin contact, the material used is biocompatible and a biological evaluated according to procedure corp proc,biol evaluation.Hearing aids are typically being worn many hours per day and it is not uncommon that the skin contact can cause minor skin irritation.However, many users get accustomed to the material and the itching or irritation.In rare cases, an allergic reaction to the earmolds can develop.In some cases, treatment with topical steroid and/or antibiotics will be necessary to stop the skin irritation.A temporary pause in the hearing aid use, or modification to the earmold shape by the hearing care professional, is also recommended to help the healing process.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.Risk assessment concluded: the risk of skin irritation / (allergy type symptoms) 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 late report.This is a a combined (initial and final) report.
Event or Problem Description
It was reported that the user experienced discomfort which gradually worsened to pain, inflammation and irritation on both ears over weeks to months.The user saw a medical professional who diagnosed the user with otitis externa and prescribed antibiotics and steriods (floxacin and dexamethasone ear drops, hydrocortisone cream, and mupirocin ointment) no known history of allergies, hypersensitivities of fungal infections no further follow up is expected.

• 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: 20461779
• Report Number: 3005650109-2024-00088
• Device Sequence Number: 18350600
• Product Code: OSM
• UDI-Device Identifier: 05708296140633
• UDI-Public: 05708296140633
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 10/16/2024

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: 20295000
• 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: 08/20/2024
• Initial Report FDA Received Date: 10/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/16/2022
• 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
• Patient Age: 82 YR
• Patient Sex: Male