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

Model Number	0780061
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Infectious Otitis Externa (4814)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is ongoing.The manufacturer has initiated a follow up to receive more information about the incident.A follow up report will be submitted upon availability of new information.
Event or Problem Description
The device was in use for 59 days.The device was removed from the patient's ear during a scheduled removal appointment.After the removal, the ent observed infection in the patient's ear.The patient was prescribed antibiotics to treat the ear.
Additional Manufacturer Narrative
The hcp reported that the patient visited ent and saw the hcp a day after, and got a new lyric device inserted.The hcp did not answer to additional questions, but this response indicates that the patient's ear must have qualified for lyric insertion.The device is not available for the analysis.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.

• Brand Name: PHONAK LYRIC4 (XS)
• 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: 21355072
• Report Number: 3005085999-2025-00002
• Device Sequence Number: 13012650
• Product Code: ESD
• UDI-Device Identifier: 07613389250879
• UDI-Public: (01)07613389250879
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2025

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: 0780061
• 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: 01/30/2025
• Supplement Date Received by Manufacturer: 03/04/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 03/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/30/2024
• 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: Female