MAUDE Adverse Event Report: SONOVA AG PHONAK LYRIC4; AIR-CONDUCTION HEARING AID, IN-CANAL

Model Number	078-0071
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Ear infection (4813)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer conducted a follow up with the initial reporter.The hcp reported that the patient came in for a routine lyric change and hearing test, however she had a significant amount of pus in her right ear that she hasn't experienced before to the hcps knowledge since the hcp has been seeing her.It was a yellow/white-ish color with a very strong odor, completely filling up her ear canal and blocking her tympanic membrane.This pus also coated and saturated the lyric device when i took it out of her ear.The patient is partially non-verbal and did not communicate any discomfort or loss of hearing prior to her appointment or at the appointment.The hcp referred the patient to see an ent, which her aide let us know that they did go for treatment.According to the aide, the patient did have an ear infection and was given antibiotic drops to take.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.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 ear infection 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.
Event or Problem Description
It has been brought to manufacturer's attention that lyric device was removed after 46 wear days.Upon the removal the hcp observed significant white/off white pus with significant odour, possible infection - ent referral.

• 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 ; laubiruetistrasse 28; staefa, zurich 8712 ; SZ 8712
• MDR Report Key: 24243978
• Report Number: 3005085999-2026-00002
• Device Sequence Number: 18201143
• Product Code: ESD
• UDI-Device Identifier: 07613389603316
• UDI-Public: (01)07613389603316
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 01/16/2026

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: 078-0071
• 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: 01/16/2026
• Initial Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/09/2025
• 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: Female