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

Model Number	0780067
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
Event or Problem Description
Upon removal of the device from the patient's ear, the hcp observed a yellow tympanic membrane.The hcp recommended the patient sees an ent.
Additional Manufacturer Narrative
The manufacturer conducted an investigation.Follow up interview (4112): the patient came for a scheduled device removal and reported no unusual symptoms.However, once device was removed the hcp observed a yellow tympanic membrance.This prompted referral to the ent.The hcp also noted mild blisters in the contralateral ear.The patient doesn't have any known previous infectants, irritations or sensitivities with lyric wear.The hcp said that prior to this removal, the insertion of the device went normally.The ent diagnosed this ear with ear infection and prescribed antibiotic drops and to not use lyric for one week.After one week, the ent cleared the patient for lyric use because the symptoms had resolved.The patient later reported itchiness in the right ear, and the ent recommended she use the antibiotic drops in both ears.Device analysis (4115): lyric is a single use device and is usually discarded and hence is not available for the analysis.Documentation/risk/clinical review: 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 and a full recovery is expected as it was also confirmed in this case.Itching, which was reported later by the patient, is a known side effect declared in the ifu, may have any causes and is often self-resolving.Historical data analysis (4109): the manufacturer checked similar complaints in the last three years and there have been no trends identified.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; stafa, zurich 8712 ; SZ 8712
• Manufacturer Contact: aleksandra enns-bray ; laubisruetistrasse 28; stafa, zurich 8712 ; SZ 8712
• MDR Report Key: 24964817
• Report Number: 3005085999-2026-00006
• Device Sequence Number: 16068289
• Product Code: ESD
• UDI-Device Identifier: 07613389603279
• UDI-Public: (01)07613389603279
• Combination Product (Y/N): N
• 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): 03/27/2026

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: 0780067
• 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: 03/27/2026
• Initial Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/10/2026
• 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