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

Model Number	PRODUCT RE9MIH-W-UP,LINX QUATTRO 9,GN RESOUND
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Skin Infection (4544); Skin Inflammation/ Irritation (4545)
Type of Reportable Event	Serious Injury
Event or Problem Description
Courtesy remake - patient is having a lot of ear infections, changing to iros vents.Sns (b)(4).The patient has reported following symptoms: redness, pain, infection, ear discharge/fluid in the ear canal.The reaction is present in both ears.It is not a recurring problem.The reaction is related to the physical fit of the hearing aid and needed larger vents for drainage.It has developed slowly over a few weeks.Primary care physician prescribed antibiotics.The medical doctor recommendation- stop wearing devices for a week while the antibiotics took effect and switching to devices with more venting.Patient did not report any known history of allergies, hypersensitivity, fungal infections or if the medical professional performed a swap for bacteria and fungi.
Additional Manufacturer Narrative
Manufacturer's reference number: (b)(4): clinical evaluation of the event: end user is currently experiencing drainage and redness and pain in both ears that is currently being treated with antibiotics.The hcp is recommending that the end user stop wearing the device for a week and is recommending a device with more ventilation.It appears that the devices themselves are not causing the infection, but, instead that the air is not properly vented based on the requirements for the end user.Clinical conclusion is that the hearing aids may be contributing to the infection, but not causing the infection from a biocompatibility standpoint.Clinical evaluation according to 0378040 clin eval plan&rpt,ha&tsg: as hearing aids are designed to have skin contact, the material used is biocompatible and a biological evaluated according to procedure # (b)(4) 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, a reaction 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 hearing aid 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.In this case, both the hcp and a pcp has been consulted.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: (b)(4) gen bte & ite risk analysis risk id u.1-8a fail to identify hyper-sensitivity.The specified above risk of hyper-sensitivity to materials specified in the risk register and there is no need for further update based on the clinical assessment, and risk register information the case is considered reportable.The device is pending investigation.
Additional Manufacturer Narrative
Manufacturer's reference number: (b)(4): clinical evaluation of the event: end user is currently experiencing drainage and redness and pain in both ears that is currently being treated with antibiotics.The hcp is recommending that the end user stop wearing the device for a week and is recommending a device with more ventilation.It appears that the devices themselves are not causing the infection, but, instead that the air is not properly vented based on the requirements for the end user.Clinical conclusion is that the hearing aids may be contributing to the infection, but not causing the infection from a biocompatibility standpoint.Clinical evaluation according to 0378040 clin eval plan&rpt,ha&tsg: as hearing aids are designed to have skin contact, the material used is biocompatible and a biological evaluated according to procedure #(b)(4) 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, a reaction 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 hearing aid 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.In this case, both the hcp and a pcp has been consulted.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: (b)(4) gen bte & ite risk analysis risk id u.1-8a fail to identify hyper-sensitivity.The specified above risk of hyper-sensitivity to materials specified in the risk register and there is no need for further update based on the clinical assessment, and risk register information the case is considered reportable.Additional information: dhr has been reviewed and no findings reported.Visual inspection reveals cerumen around the battery doors and minimal debris in the vents.Some moisture has been noted in the receiver wires.Listening check reveals good volume and sound quality.No further investigations will be performed.The patient has received new device.This is a final report.
Event or Problem Description
Courtesy remake - patient is having a lot of ear infections, changing to iros vents.Sns (b)(6).The patient has reported following symptoms: redness, pain, infection, ear discharge/fluid in the ear canal.The reaction is present in both ears.It is not a recurring problem.The reaction is related to the physical fit of the hearing aid and needed larger vents for drainage.It has developed slowly over a few weeks.Primary care physician prescribed antibiotics.The medical doctor recommendation- stop wearing devices for a week while the antibiotics took effect and switching to devices with more venting.Patient did not report any known history of allergies, hypersensitivity, fungal infections or if the medical professional performed a swap for bacteria and fungi.Follow up received on 27jun2022: on 5/18/22 patient confirmed that the doctor diagnosed with ear infection and told the patient to wait to wear device until the infection cleared up.The patient was prescribed antibiotics.Patient did not want to share medical history.These are the only hearing aids patient has ever worn.

• 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: 14564218
• Report Number: 3005650109-2022-00006
• Device Sequence Number: 17586140
• Product Code: OSM
• UDI-Device Identifier: 05708296174898
• UDI-Public: 05708296174898
• 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): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2022

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: PRODUCT RE9MIH-W-UP,LINX QUATTRO 9,GN RESOUND
• Device Catalogue Number: UKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2022
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/06/2022
• Supplement Date Received by Manufacturer: 05/06/2022
• Initial Report FDA Received Date: 06/01/2022
• Supplement Report FDA Received Date: 06/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/10/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown