MAUDE Adverse Event Report: SONOVA AG PHONAK VIRTO P50-312; AIR-CONDUCTION HEARING AID, IN-THE-EAR

Model Number	063-0510-01
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Ear infection (4813)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Follow up with the hcp and patient's relative has been carried to clarify the nature of incident (allergy / infection).The information obtained confirms infection.The patient / hcp requested a remake of the hearing aids and sent them back to the manufacturer.The his were received by the manufacturer.Applicable adjustments have been made to the devices.The modeling files of initial and remake order have been reviewed.Virto p is an ite hearing aid and its outer shell is individually produced for each client to fit the patients' ear anatomy.The hearing aids were manufactured based on the patient's ears impressions in a way to provide for best audiological gain to compensate for the hearing loss of the patient.The seal the ear canal needed to provide for the controlled acoustic coupling was adjusted to the parameters of the patient's ear impression.A tight seal may foster restrained air circulation and moisture accumulation, which for patients susceptible for infections may lead to infection development.This is however a well-known disadvantage of conventional hearing aids, widely described in available literature and presented in the clinical evaluation report of the subject device.The risk file of the device already considers and addresses the risk of ear infection.The user guide of the device contains the device care and maintenance instructions, dedicated information on safety (explaining how to store the device when not used to enable evaporation of moisture) plus a warning to inflammation/skin irritation requiring check with an hcp or physician.Once the devices were returned for remake, there were several adjustments made to the his following the remake order placed by the hcp.The adjustments carried out enable for more relaxed fit of the his to the patient's ear canal that would loosen the seal and allow for more air circulation (shell remodeling, vent change, additional relaxing cuts).The his were returned to the clinic and were fitted back to the patient on (b)(6), the patient is doing well with the remade hearing aids, with no signs of infection.This is the final report.
Event or Problem Description
It has been brought to the manufacturers attention that the patient suffered from swelling and redness in the ear potentially linked to the use of hearing aids.Initially suspected allergy reaction was disproved by the patient's daughter.According to the patient's daughter, the patient has visited a family doctor, who diagnosed ear infection and prescribed antibiotics drops (ciprofloxacin) on (b)(6).Patient's daughter reports the infection is improving greatly with antibiotics treatment.She also underlines that the patient has no allergies or a history of allergies.The event concerns both ears and both devices: (b)(6).A separate report has been filed for device (b)(6): 3005085999-2025-00009.

• Brand Name: PHONAK VIRTO P50-312
• Common Device Name: AIR-CONDUCTION HEARING AID, IN-THE-EAR
• Manufacturer (Section D): SONOVA AG; laubisrütistrasse 28; stäfa, zürich 8712 ; SZ 8712
• Manufacturer Contact: aleksandra enns-bray ; laubisrütistrasse 28; stäfa, zürich 8712 ; SZ 8712
• MDR Report Key: 21855537
• Report Number: 3005085999-2025-00008
• Device Sequence Number: 4684478
• Product Code: OSM
• UDI-Device Identifier: 07613389452037
• UDI-Public: (01)07613389452037
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date (Section B): 03/26/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 063-0510-01
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2025
• Initial Report FDA Received Date: 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2025
• 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