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

Model Number	20293500
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's ref# (b)(6).Manufacturer's investigation: manufacturer's investigation is ongoing.A final report will be submitted upon completion of the investigation this is an initial report.
Event or Problem Description
Estimated date of incident (b)(6) 2024.It was reported that the brass ring that holds the wax filter in place, fell out of a new earmould.No harm to the user has been reported.Further follow up is expected.
Additional Manufacturer Narrative
Manufacturer's ref# sf (b)(4).Manufacturer's investigation: manufacturer's investigation is ongoing.A final report will be submitted upon completion of the investigation this is an initial report.16-aug-2024: technical investigation concluded: a dhr review have been completed.No deviation or changes were found during manufacturing of the device.Devic investigation concluded: upon further investigation, it was found that the original cerustop was installed as there are signs of installation.No root cause can be found for missing it upon arrival.The clinical investigation concluded: the clinical evaluation for the device family does evaluate objects such as 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 is also risk that a hearing aid's ear mold may be damaged and potentially broken due to unexpected external mechanical force beyond typical use, and this is of most concern in the context of harder acrylic molds.Should an earmold break due to mechanical force, there is a possibility that the damage results in the creation of exposed sharp edges.These sharp edges could potentially cause harm in the ear canal, likely only superficial in nature.If the earmold is accidentally dropped to the floor and then cracked or shattered into pieces, it is evaluated as very unlikely that the users may get harmed due to sharp corners and edges as the damage itself is obvious to the users.The brass ring dislodged during wax filter change.As the wax filters cannot be removed without a tool, it is evaluated very unlikely the brass ring would break in the ear.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: this risk is generally known, mitigated and communicated to the user.The risk is deemed to be of an acceptable nature.This is a final report.
Event or Problem Description
Estimated date of incident (b)(6) 2024.It was reported that the brass ring that holds the wax filter in place, fell out of a new earmould.No harm to the user has been reported.Further follow up is expected.16-aug-2024: brass ring dislodged during wax filter change.

• 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: 19781880
• Report Number: 3005650109-2024-00062
• Device Sequence Number: 12831784
• Product Code: OSM
• UDI-Device Identifier: 05708296140480
• UDI-Public: 05708296140480
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Followup
• Report Date (Section B): 08/16/2024

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: 20293500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2024
• Supplement Date Received by Manufacturer: 06/21/2024
• Initial Report FDA Received Date: 07/19/2024
• Supplement Report FDA Received Date: 08/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown