MAUDE Adverse Event Report: SONOVA AG PHONAK AUDEO L90-R; HEARING AID, AIR-CONDUCTION, RECEIVER-IN-CANAL

Model Number	0500889P5
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 involving phonak l90-r used by a 6-year old child.While at school using the hearing aid under regularly, he complained that the device was becoming hot and his teacher removed it from his ear.The device then stopped functioning entirely.Fortunately, no injury occurred, but the incident was concerning due to the overheating occurring directly in a child's ear.

• Brand Name: PHONAK AUDEO L90-R
• Common Device Name: HEARING AID, AIR-CONDUCTION, RECEIVER-IN-CANAL
• Manufacturer (Section D): SONOVA AG; laubisrütistrasse 28; stafa, zurich ,che 8712 ; SZ 8712
• MDR Report Key: 23901375
• Report Number: 3008848788-2025-00024
• Device Sequence Number: 5029551
• Product Code: OSM
• UDI-Device Identifier: 07613389477832
• UDI-Public: (01)07613389477832
• Combination Product (Y/N): N
• 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
• Type of Report: Initial
• Report Date (Section B): 12/05/2025
• Report Date (Section F): 12/05/2025

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: 0500889P5
• Distributor Facility Aware Date: 12/05/2025
• Device Age: 14 MO
• Date Report to Manufacturer: 12/05/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/27/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 6 YR
• Patient Sex: Unknown