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

Model Number	0780069
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Fluid Discharge (2686)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lyric device was worn for 23 days and was removed due to dead device.White fluid was observed in patient's ear and the eardrum was not visible.The hcp referred the patient to see a gp.The gp prescribed patient ear drops for 7 days.The ear has healed and the patient was successfully re-fitted with lyric.The device is not available for the analysis.It is unknown if the patient has any pre-existing conditions or if there were other contributing factors.The manufacturer did not record any complaint trends for this issue on the market.The risk of accumulation of moisture in the ear due to device's design and sealed fit in the ear has been already considered in the accompanying risk file.The ifu contains information about common side effects such as e.G.Ear pain, moisture and blisters, as well as, information on contraindications and referral criteria.This is the final report.The manufacturer will observe for trends.
Event or Problem Description
It was reported to the manufacturer that the patient using lyric device experienced sore or ulceration of tissue.The ear was fully blocked with white content in the ear canal.Eardrum was not visible.

• Brand Name: PHONAK LYRIC4 (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: 22539664
• Report Number: 3005085999-2025-00017
• Device Sequence Number: 8028244
• Product Code: ESD
• UDI-Device Identifier: 07613389603293
• UDI-Public: 07613389603293
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 05/01/2025

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: 0780069
• 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: 05/01/2025
• Initial Report FDA Received Date: 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/03/2025
• 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