MAUDE Adverse Event Report: SONOVA AG PHONAK LYRIC4; 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 infection (4813); Infectious Otitis Externa (4814); Infectious Otitis Media (4815)
Type of Reportable Event	Serious Injury
Event or Problem Description
It has been brought to manufacturer's attention that lyric device was removed after 56 wear days.Upon the removal the hcp observed redness of tissue and infection.

• Brand Name: PHONAK LYRIC4
• 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: 23490697
• Report Number: 3008848788-2025-00014
• Device Sequence Number: 8625254
• Product Code: ESD
• UDI-Device Identifier: 07613389603293
• UDI-Public: (01)07613389603293
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 10/13/2025
• Report Date (Section F): 10/13/2025

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: 10/13/2025
• Device Age: 4 MO
• Event Location: Home
• Date Report to Manufacturer: 10/13/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/06/2025
• 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: Male