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

Model Number	22406505
Medical Device Problem Codes	Product Quality Problem (1506); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's ref# (b)(4).Manufacturer's investigation: technical investigation concluded: serial number was not available so it was not possible to do a device history record review.Clinical conclusion: clinical evaluation of the event: it was reported that the receiver separated when the patient pulled it out of his ear.The event separated receiver did not require removal and has not caused harm.The user has not experienced this issue before and is an experienced user.The receiver was replaced and the hearing care professional recommended more checkups.Clinical evaluation according to clin eval plan & rpt,ha&tsg and clin eval plan&rpt,other acc: the clinical evaluation for the device family does evaluate receivers 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 hcp if a foreign object or wax is located 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 known risk.In general risks related to mechanical damage are known, considered in the risk analysis, mitigated and communicated to the user.This risk is deemed to be acceptable.Device investigation concluded: device was discarded so it was not possible to do a device investigation.Trended case device investigation findings: inadequate pfmea assessment on insufficient glue application.No mechanism to specify and control the glue application amount since this process is human driven with inconsistency the exact bonding evaluation method is divert.The bonding shall be conducted between housing and receiver contact point.Not on front housing tip and receiver cable instead.Manufacturer's investigation is final.This is a combined (initial and final) report.
Event or Problem Description
It has been reported that receiver of a hearing aid separated when the user pulled it out of his ear.No object was stuck in the ear, no harm or injury reported.No further follow up information 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: 20351376
• Report Number: 3005650109-2024-00080
• Device Sequence Number: 8053826
• Product Code: OSM
• UDI-Device Identifier: 05708296253852
• UDI-Public: 05708296253852
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/01/2024

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: 22406505
• 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: 09/03/2024
• Initial Report FDA Received Date: 10/02/2024
• 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: Male