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

Model Number	20295200
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Infectious Otitis Externa (4814)
Date of Event	10/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer's ref# (b)(4).Manufacturer's investigation: technical investigation concluded: device history register review have been completed.No deviation or changes were found during manufacturing of the device.Clinical conclusion: clinical evaluation of the event: it was reported that the mould triggered otitis externa from the mold of hearing aid.Reaction is present only on external parts and pinna of the left ear and developed slowly over months.This is an experienced user who has had this issue before and is known to have recurrent ear infections.Hearing care professional believes this is related to the physical fit of the hearing aid.The user has a known history of allergies, hypersensitivities or fungal infections but it is not mentioned what particular history the user has.The user saw emergency department and an ear-nose-throat doctor and the doctor recommended a softer mold with less friction.A swab for bacteria and fungi was taken but it is not known what the outcome was.The user was prescribed medication, but it is not stated which type of medication it was.Clinical evaluation according to clinical evaluation plan:: as hearing aids will need to have skin contact, the risk of ear infection is present.Primary infections from hearing aids is not possible as hearing aids are made of non-biological material.However, the risk of infection in ears can increase with the use of hearing aids.Human skin is regularly contaminated, and daily handling of hearing aids increases the risk of transferring bacteria to the ears.In rare cases a fungal infection in the ear canal can develop.These infections have good circumstances in dark and humid environments and is typically seen in more occluded fittings (custom ear moulds/shells) where adequate air ventilation in the ear canal is prevented.Fungal infections can be treated with medical prescriptions and proper ventilation in the ear moulds/shells.If the fungal infection is recurrent, removing the hearing aid whenever it is not being actively used and cleaning the hearing aid can help prevent it.The user guide includes a caution that hearing aids should be cleaned daily to avoid skin irritation or infection from ear wax or other residue on the hearing aids.Hearing aids, by design, are meant to be worn in/on the ear and handled by the end user and hearing care professional.As the devices are physically touching the ear/ear canal there are risks of infection in cases where there was contaminated handling often devices or improper cleaning, should a detachable portion of the hearing aid (e.G., dome, wax filter) become lodged in the ear canal, or as, above, a damaged device causing cuts/scratches to the ear resulting in infection.Not cleaning hearing aids and/or ear molds at all or well enough can also in rare cases cause contamination resulting in irritation, infection or allergic reactions.Users of hearing aids are to be guided in how to maintain their hearing aids and information can also be found in user guides.This to minimize the risk of irritation, infection or allergic reactions.It is concluded that the benefit of wearing a hearing aid outweighs this risk.Risk assessment: risks related to skin contact, including poor physical fit, in possible conjunction with pre-existing medical conditions are generally known, considered in the risk analysis and communicated to the user.This risk is deemed to be acceptable.Manufacturer's investigation is final.This is a combined (initial and final) report.
Event or Problem Description
Date of incident: (b)(6) 2024.It was reported that mould on hearing aid triggered otitis externa on left ear.No further follow up is available.

• 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: 20692933
• Report Number: 3005650109-2024-00102
• Device Sequence Number: 7196826
• Product Code: OSM
• UDI-Device Identifier: 05708296140657
• UDI-Public: 05708296140657
• 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
• Report Date (Section B): 11/15/2024

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: 20295200
• 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: 10/19/2024
• Initial Report FDA Received Date: 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 56 YR
• Patient Sex: Female