MAUDE Adverse Event Report: Sonova AG Phonak Virto I70-R; Air-conduction hearing aid, in-the-ear

Model Number	063052701
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received a complaint via a service order stating that the hearing aid is causing burning sensation when placed behind the ear and is hot to touch when removed.The device is showing red light while in charger (does not charge).No actual harm to the patient was reported.
Additional Manufacturer Narrative
The manufacturer initiated an investigation, including, among others, follow-up with the hcp, traceability checks, labelling review and confirmation of whether the device is available for analysis.Additional reports will be submitted as new investigation findings become available.

• Brand Name: Phonak Virto I70-R
• Common Device Name: Air-conduction hearing aid, in-the-ear
• Manufacturer (Section D): Sonova AG; laubisruetistrasse 28; staefa, 8712 ; SZ 8712
• Manufacturer Contact: aleksandra enns-bray ; laubisruetistrasse 28; staefa, 8712 ; SZ 8712
• MDR Report Key: 50928081
• Report Number: 3005085999-2026-00031
• Device Sequence Number: 10735236
• Product Code: OSM
• UDI-Device Identifier: 07613389626261
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/10/2026

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: 063052701
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2026
• Initial Report FDA Received Date: 09/29/2026
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown