MAUDE Adverse Event Report: Sonova AG Phonak Audeo L90-R; Hearing aid, receiver-in-canal

Model Number	050-0889-P5
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
Sonova received a complaint through a service repair order indicating that a hearing aid became hot and subsequently ceased functioning.No patient injury, medical intervention, or other adverse health consequences were reported in association with the event.
Additional Manufacturer Narrative
The manufacturer has initiated an investigation into the reported event.The investigation includes follow-up with the hcp, verification of traceability, review of the service history and labeling, and confirmation of the device's availability for evaluation.This is an initial report.Additional reports will be submitted as new information becomes available.

• Brand Name: Phonak Audeo L90-R
• Common Device Name: Hearing aid, receiver-in-canal
• Manufacturer (Section D): Sonova AG; laubisruetistrasse 28; staefa, zurich 8712 ; SZ 8712
• Manufacturer Contact: aleksandra enns-bray ; laubisruetistrasse 28; staefa, 8712 ; SZ 8712
• MDR Report Key: 50933339
• Report Number: 3005085999-2026-00032
• Device Sequence Number: 21265958
• Product Code: OSM
• UDI-Device Identifier: 07613389477832
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• 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): 08/31/2026

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: 050-0889-P5
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/29/2026
• Date Device Manufactured: 08/21/2025
• 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