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

Model Number	RE9MIH-W-HP
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Ear infection (4813)
Date of Event	09/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer's ref# (b)(4).Technical investigation concluded: a dhr review have been completed.No deviation or changes were found during manufacturing of the device.The clinical investigation concluded: clinical evaluation of the event: it is reported that the user developed an ear infection and was prescribed antibiotics(otofloxacin).It is unknown if the ear infection was in the ear canal or in the middle ear.The user has been wearing the device since 2019 and reports having itchy and scaly skin consistently over the years.Hearing care provider saw the user in april and noticed scaly skin in both ears and what looked like an infection in the right ear.Hcp suggested user to go to general practitioner.On an unknown time, the user went to the ent and was diagnosed with ear infection.There is no history of allergies, hypersensitivity or fungal infections for the user.Clinical conclusion on this case is that based on the available information, it cannot be ruled out that the reaction was caused by use of the hearing aids.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.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: risks related to skin reaction / sensitization as well as risks involving pre-existing medical conditions are generally known, considered in the risk analysis, mitigated 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
On an unknown time between (b)(6) 2024 user developed an ear infection and was prescribed antibiotics(otofloxacin).It is unknown if the ear infection was in the ear canal or in the middle ear.The user has been wearing the since 2019 and reports having itchy and scaly skin consistently over the years.Hearing care provider saw the user in april and noticed scaly skin in both ears and what looked like an infection in the right ear.Hcp suggested user to go to general practitioner.On an unknown time, the user went to the ent and was diagnosed with ear infection.There is no history of allergies, hypersensitivity or fungal infections for the user.

• 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: 20367647
• Report Number: 3005650109-2024-00081
• Device Sequence Number: 19755358
• Product Code: OSM
• UDI-Device Identifier: 05708296174874
• UDI-Public: 05708296174874
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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): 10/04/2024

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: RE9MIH-W-HP
• 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: 09/05/2024
• Initial Report FDA Received Date: 10/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2019
• 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: Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male