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

Model Number	RLY3ITC-DW-MP
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer's ref (b)(4).(b)(6) 2023: a device history record review has been completed and have found that the root cause of this issue came from production as aid was not properly cleaned before it went out.The image of crack on the edge of the ha is caused by the glue protruding out of the receiver as the tech has placed excess amount of glue inside.When the tube was pushed outwards, it brought the excess glue from inside the channel to the surface and cured making it appear as if it is a crack.Investigation is still in progress.
Event or Problem Description
(b)(6) 2023: it has been reported that wax filters in the hearing aid have fallen off in user's ears.The user had to go to hospital to get them removed.The white ring casing that houses the wax filter looks to be cracked.The wax filters do not sit neatly, they protrude more than normal and don't sit symmetrically flat.
Event or Problem Description
On 18-apr-2023: it has been reported that wax filters in the hearing aid have fallen off in user's ears.The user had to go to hospital to get them removed.The white ring casing that houses the wax filter looks to be cracked.The wax filters do not sit neatly, they protrude more than normal and don't sit symmetrically flat.
Additional Manufacturer Narrative
Manufacturer's ref# (b)(4).On 18-apr-2023: a device history record review has been completed and have found that the root cause of this issue came from production as aid was not properly cleaned before it went out.The image of crack on the edge of the ha is caused by the glue protruding out of the receiver as the tech has placed excess amount of glue inside.When the tube was pushed outwards, it brought the excess glue from inside the channel to the surface and cured making it appear as if it is a crack.Investigation is still in progress.On 16-may-2023: the clinical investigation concluded: the clinical evaluation for the device family does evaluate wax filter remaining in the ear canal after hearing aid removal.The hazard is identified in the risk analysis and mitigated on device design by ensuring that the wax filter cannot be removed without a tool.The user guide states to contact the hcp if a foreign object is in the ear canal to reduce the potential risk of harm as far as possible.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 conclusion: the residual risk after the risk control measure(s) is acceptable.No new hazardous situations revealed and no need to update the risk register.This case is considered as a single incident and will be included in regular trending.No actions have been initiated based on this individual event.Manufacturer's investigation is final.This is a final report.

• 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: 16766826
• Report Number: 3005650109-2023-00051
• Device Sequence Number: 19642688
• Product Code: OSM
• UDI-Device Identifier: 05708296208142
• UDI-Public: 05708296208142
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2023

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: RLY3ITC-DW-MP
• 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: 03/20/2023
• Supplement Date Received by Manufacturer: 03/20/2023
• Initial Report FDA Received Date: 04/19/2023
• Supplement Report FDA Received Date: 05/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2021
• 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 Sex: Unknown