MAUDE Adverse Event Report: SONOVA AG PHONAK LYRIC 4 (L); HEARING AID, COMPLETELY-IN-CANAL

Model Number	0780071
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Fluid Discharge (2686)
Date of Event	07/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer was notified that a patient using lyric device experienced moisture in the ear canal.The hcp cleared ear and prescribed drops.

• Brand Name: PHONAK LYRIC 4 (L)
• Common Device Name: HEARING AID, COMPLETELY-IN-CANAL
• Manufacturer (Section D): SONOVA AG; laubisrütistrasse 28; stafa, zurich ,che 8712 ; SZ 8712
• MDR Report Key: 22836011
• Report Number: 3008848788-2025-00004
• Device Sequence Number: 9410431
• Product Code: ESD
• UDI-Device Identifier: 07613389603316
• UDI-Public: (01)07613389603316
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 07/31/2025
• Report Date (Section F): 07/31/2025

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: 0780071
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/31/2025
• Device Age: 14 MO
• Event Location: Home
• Date Report to Manufacturer: 07/31/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/18/2025
• 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