MAUDE Adverse Event Report: Sonova AG Phonak CROS L-R; Contralateral hearing unit

Model Number	0501013P5
Medical Device Problem Codes	Overheating of Device (1437); Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Sonova received a repair order stating that the device got very hot, almost burned the patient and won't charge.

• Brand Name: Phonak CROS L-R
• Common Device Name: Contralateral hearing unit
• Manufacturer (Section D): Sonova AG; laubisruetistrasse 28; stafa, zurich, che 8712 ; SZ 8712
• MDR Report Key: 50484750
• Report Number: 3008848788-2026-00012
• Device Sequence Number: 18665459
• Product Code: OSM
• UDI-Device Identifier: 07613389502954
• UDI-Public: (01)07613389502954
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/27/2026
• Report Date (Section F): 08/27/2026

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: 0501013P5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/30/2026
• Device Age: 6 MO
• Event Location: Home
• Date Report to Manufacturer: 07/29/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/27/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown