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 blood and fungal infection.
Additional Manufacturer Narrative
The manufacturer conducted a follow up with the initial reporter.The hcp reported that when the lyric devices were removed there was excessive wax and bleeding.The notes from the patient's physician state the cerumen of bilateral ears was impacted with ear infection.The patient was diagnosed with acute right otitis media and acute otitis externa of left ear, unspecified type.The patient was placed on ciprodex drops twice a day for ten days to the right ear.For the left ear, lotrisone cream was placed.Follow up visit with the physician was scheduled in 4-6 weeks, but the patient was travelling and was supposed to turn in upon return.The patient has not been back to the office since being treated by physician but has decided not to continue use of lyric devices.This case (sn: (b)(6)) is linked to the one for sn: (b)(6), which was opened for the other device of the same patient (the other ear).Lyric is a single use device and is usually discarded and hence is not available for the analysis.The device is designed to be worn deep within the ear canal, effectively sealing it as intended.However, this sealing can potentially lead to moisture accumulation in the space between the device and the eardrum.Such moisture retention may compromise skin integrity, creating a moist and dark environment that is conducive to bacterial growth.This environment can occasionally result in skin irritations or infections.Related to the deep inserted extended wear of lyric, symptoms such as abrasions, bleeding, ulcers and otitis externa tend to occur most commonly as a result of traumatic insertion, sizing error, poor placement or patient manipulation.The self-removal instruction is given in the device's ifu.It is said to use a gentle circular motion to remove the hearing aid.Ear infection and other symptoms related to the deep insertion of lyric have already been considered in the device's clinical evaluation report and risk file.The accompanying ifu lists actions to take when ear pain, irritation or inflammation occurs and to seek medical advice.It should be also noted that otitis externa is a relatively common condition that can occur independently of hearing aid use.The manufacturer checked for similar complaints in the last three years and there have been no trends identified.The manufacturer will keep observing for trends.This is the final report.

• Brand Name: PHONAK LYRIC4
• Common Device Name: AIR-CONDUCTION HEARING AID, IN-CANAL
• Manufacturer (Section D): SONOVA AG; laubisruetistrasse 28; staefa, zurich 8712 ; SZ 8712
• Manufacturer Contact: aleksandra enns-bray ; laubistruetistrasse 28; staefa, zurich 8712 ; SZ 8712
• MDR Report Key: 23434431
• Report Number: 3005085999-2025-00036
• Device Sequence Number: 4733336
• Product Code: ESD
• UDI-Device Identifier: 07613389603293
• UDI-Public: (01)07613389603293
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 10/08/2025

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2025
• Initial Report FDA Received Date: 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/10/2025
• 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: Male