MAUDE Adverse Event Report: SONOVA AG PHONAK LYRIC4 (S); AIR-CONDUCTION HEARING AID, IN-CANAL

Model Number	078-0069
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Ear Pain (4812); Ear infection (4813)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to the manufacturer that the removal at 2 week follow up appointment was extremely difficult, resulting in bleeding, hematomas and revealing infection in both ears.

• Brand Name: PHONAK LYRIC4 (S)
• Common Device Name: AIR-CONDUCTION HEARING AID, IN-CANAL
• Manufacturer (Section D): SONOVA AG; laubisrütistrasse 28; stafa, zurich ,che 8712 ; SZ 8712
• MDR Report Key: 23624781
• Report Number: 3008848788-2025-00016
• Device Sequence Number: 9032402
• Product Code: ESD
• UDI-Device Identifier: 07613389603293
• UDI-Public: (01)07613389603293
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 10/24/2025
• Report Date (Section F): 10/24/2025

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: 078-0069
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/24/2025
• Device Age: 5 MO
• Event Location: Home
• Date Report to Manufacturer: 10/24/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/21/2025
• 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