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

Model Number	IMG6ITE-DWC-MP
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Skin Burning Sensation (4540)
Date of Event	05/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2023 (best estimate) it was alleged that patient's right hearing aid was "burning hot" after a night in the charger.Patient dropped them because it was so "so hot that he burned himself on it".Follow up information received : "there was a little bit of red on one finger, but it wasn't much.Photo is probably no longer possible as it is gone now.But it wasn't that bad".
Additional Manufacturer Narrative
Manufacturer's reference: (b)(4).Technical investigation concluded: device history record review has been completed.No deviation or changes were found during manufacturing of the device.Investigation is still in progress.A final report will be submitted upon completion.
Additional Manufacturer Narrative
Manufacturer's reference: (b)(4).Technical investigation concluded: device history record review has been completed.No deviation or changes were found during manufacturing of the device.Investigation is still in progress.A final report will be submitted upon completion.21 jul 23: technical investigation concluded: a dhr review was performed and no deviations were identified.Device was returned and investigated: no safety related issues were found in the investigations, but the charger was found to have a problem charging the left device.The left device did not contribute to the incident.Regarding the observation by the user - a device near its charging cycle will have a raised temperature, which is expected and normal behaviour.The left hearing aid was reporting a failure.Charging in another c-4 charger was functioning as expected.This most likely means that the coil alignment is out of specification.The right side is charging as expected.For the user to get a superficial burn the temperature would have to be much higher than the raised temperature caused by the charger.Also the mass of the hearing aid is very small, meaning that the temperature of the device will drop rapidly when touched by the user.Clinical assessment concluded: it has been reported that the right hearing aid was burning hot after a night in the charger.Upon touching the hearing aid, the user dropped it on the tiled floor, because it was so hot that he burned himself on it.When it hit the floor, it punctured the hearing aid.The issue was only present for the right hearing aid, left was not hot.On the charger itself, before he opened it, the left lamp was constantly on, but the right one was blinking like it was still charging.The hcp ad previously sanded the right hearing aid to fit the user's canal better.It is unknown if this could have contributed to this issue.The alleged burn has not been medically confirmed and the user sought not any medical attention.It was reported that the hot hearing aid left a small red mark on the finger of the user.Other than the burn on the finger, there was no harm to the user, and no report of property damage.Rechargeable hearing aids can get warm in failure mode.This has been investigated and results show that a faulty rechargeable hearing aid can rise to 44°- 46° c while in the charger.Once the hearing aid is retracted from the charger the energy transmission from the charger stops and - assisted by the cooling from surrounding air and/or the fingers of the end user - the surface temperature immediately begins to drop.Because of the immediate drop in temperature, the hearing aids are regarded safe in this single fault condition.Rechargeable hearing aids could also cause high temperatures, leading to burns, if the sealing is compromised, if a short circuit should occur (e.G., because of a drop or a compromised sealing), or if a hardware or software failure should occur.This is reduced as far as possible by the two-barrier ingress protection, by implementing sealing of the rechargeable battery and 4.2c electronics and by testing the batteries according to standards.Based on the information the case is now considered not reportable as the event / incident did not lead to, or might led to, death or a serious injury.Manufacturer's investigation is final, this is a final report.
Event or Problem Description
On 22 may 2023 (best estimate) it was alleged that patient's right hearing aid was "burning hot" after a night in the charger.Patient dropped them because it was so "so hot that he burned himself on it".Follow up information received : "there was a little bit of red on one finger, but it wasn't much.Photo is probably no longer possible as it is gone now.But it wasn't that bad".

• Brand Name: BELTONE
• 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: 17171802
• Report Number: 3005650109-2023-00082
• Device Sequence Number: 7154475
• Product Code: OSM
• UDI-Device Identifier: 05708296217564
• UDI-Public: 05708296217564
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2023

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: IMG6ITE-DWC-MP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2023
• Supplement Date Received by Manufacturer: 05/22/2023
• Initial Report FDA Received Date: 06/21/2023
• Supplement Report FDA Received Date: 07/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/23/2022
• 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 Sex: Male