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

Model Number	22850175
Medical Device Problem Codes	Product Quality Problem (1506); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Unspecified Ear or Labyrinth Problem (4474)
Date of Event	04/23/2004
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's ref# (b)(4).Manufacturer's investigation: technical investigation concluded:a dhr review have been completed.No deviation or changes were found during manufacturing of the device clinical conclusion: clinical assessment of the event: it was reported that on the (b)(6) 2024 the user called because she had been reporting feedback & intermittency with the left aid.When the ear was examined it was discovered that there was a dome in the ear canal.The user had to be referred to medical facility to get the dome removed.The clinical evaluation is that the event will not cause harm to the user.Clinical evaluation according to clin eval plan&rpt,other acc: the clinical evaluation for the device family does evaluate domes coming loose in the ear canal.This is identified in the risk analysis and mitigated through device design by ensuring a sufficient pull force (compliance with iec 60601-2-66).The user guide states to contact the hearing care professional if a foreign object or wax 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 assessment: this is a generally known risk, considered in the risk analysis, mitigated and communicated to the user.Such risks are generally deemed to be of an acceptable nature.Manufacturer's investigation is final.This is a combined (initial and final) report.
Event or Problem Description
T was reported that on the (b)(6) 2024 the user called because she had been reporting feedback & intermittency with the left aid.When the ear was examined it was discovered that there was a dome in the ear canal.The user had to be referred to medical facility to get the dome removed.No harm to the user has been reported.No further follow up is expected.

• 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: 19380247
• Report Number: 3005650109-2024-00046
• Device Sequence Number: 7688984
• Product Code: OSM
• UDI-Device Identifier: 05708296315956
• UDI-Public: 05708296315956
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 05/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 22850175
• 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: 04/23/2024
• Initial Report FDA Received Date: 05/23/2024
• 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 Sex: Female