MAUDE Adverse Event Report: SONOVA AG PHONAK VIRTO P50-10 NW O; AIR-CONDUCTION HEARING AID, IN-THE-EAR

Model Number	063-0508-01
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Event or Problem Description
It has been brought to manufacturer's attention that the wax filter of the hearing aid stuck in patient's ear.Patient had to go to gp to have the wax filter removed.
Additional Manufacturer Narrative
Manufacturer has initiated a follow up interview and medical device technical file review.Location of the device is being established.This is the initial report.Follow up report will be submitted upon receipt of further information.
Additional Manufacturer Narrative
Manufacturer has reached out to the hcp and established there has been nothing untoward with the patient.The hcp does not recall removing any external parts from the ear canal.They report no visible accidental damage to the device.There are no pictures of the device nor of the reported incident.The device is not available for analysis.Manufacturer has checked the modelling files and the production order of this device and confirms the modelling of the wax guard was done correctly.Manufacturer confirms that wax guard is a detachable part of the hearing aids by design.An applicable risk on the detachable parts of the device remaining in the ear canal is present in the risk assessment of this device.Risk control measures, including appropriate warning in the user guide, are implemented.The risk file of the subject device has been checked and the risks corresponding to the incident have already been addressed within and are considered valid and accurate.Manufacturer has reviewed the user guide of the subject device, where the presence of an information referring the patient to contact the hcp if the hi fails to operate after wax guard system replacement.The user guide also contains a warning adequate to the subject incident, where a patient is advised to visit an hcp in case the wax filter remains in the ear canal.

• Brand Name: PHONAK VIRTO P50-10 NW O
• Common Device Name: AIR-CONDUCTION HEARING AID, IN-THE-EAR
• Manufacturer (Section D): SONOVA AG; laubisruetistrasse 28; staefa, zurich 8712 ; SZ 8712
• Manufacturer Contact: aleksandra enns-bray ; laubisrütistrasse 28; stäfa, zürich 8712 ; SZ 8712
• MDR Report Key: 22749387
• Report Number: 3005085999-2025-00024
• Device Sequence Number: 15842385
• Product Code: ESD
• UDI-Device Identifier: 07613389452013
• UDI-Public: (01)07613389452013
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2025

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: 063-0508-01
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/08/2025
• Supplement Report FDA Received Date: 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/10/2022
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown