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

Model Number	0780062
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fluid Discharge (2686); Ear infection (4813)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Despite several contact attempts via email and phone it was not possible to establish contact with the initial reporter.It is therefore unknown if the patient received any medical treatment and if the diagnosis (infection) was confirmed.The risk file already considers and addresses the risk of moisture accumulation in the ear due to device being placed inside the ear and having tight fit.The user guide contains a warning that instructs the user to check with the hcp or physician in case of pain, irritation or other symptoms.The manufacturer will observe for trends.This is the final report.
Event or Problem Description
It was reported to the manufacturer that dark green fluid was observed in the patient's ear canal upon lyric removal.The device was in use for 53 days and was removed during a scheduled removal appointment.The hcp is suspecting an infection and had referred the patient to the ent before the placement of a new lyric device.

• Brand Name: PHONAK LYRIC (S)
• Common Device Name: HEARING AID, COMPLETELY-IN-CANAL
• Manufacturer (Section D): SONOVA AG; laubisruetistrasse 28; stafa, zurich 8712 ; SZ 8712
• Manufacturer Contact: aleksandra enns-bray ; laubisruetistrasse 28; stafa, zurich 8712 ; SZ 8712
• MDR Report Key: 21933768
• Report Number: 3005085999-2025-00010
• Device Sequence Number: 8907344
• Product Code: ESD
• UDI-Device Identifier: 07613389250886
• UDI-Public: (01)07613389250886
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/15/2025

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: 0780062
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2025
• Initial Report FDA Received Date: 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/17/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown