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
Event or Problem Description
It has been brought to manufacturer's attention that lyric device was removed after 8 wear days and that the subscription was cancelled.Upon the removal the hcp observed excess fluid collection on tissue.
Additional Manufacturer Narrative
The manufacturer conducted a follow up with the initial reporter.The hcp reported that when the lyric device was removed it sounded wet and sticky.After removal the hcp noticed distinct odor.The patient did not complain about the aid, nor did they report any discomfort until they noticed a feeling the device stopped working, presumably due to the fluid in the ear canal.The hcp reports this patient has been experiencing issues with previous lyric insertions for a couple of times.For the first couple of months was the patient did not show any symptoms, later fluid discharge and inflammation consistent with infection started.The hcp reports no displacement of the device.The patient has been treated with a series of antibiotics.The ear was put on rest until completely healed.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 infection (otitis externa) tend to occur most commonly as a result of traumatic insertion, sizing error, poor placement, patient manipulation or individual patient's predispositions for 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 otitis externa is a relatively common condition that can occur independently of hearing aid use and a full recovery is expected.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 ; laubisruetistrasse 28; staefa, 8712 ZURIC-H ; SZ ZURICH
• MDR Report Key: 24998314
• Report Number: 3005085999-2026-00007
• Device Sequence Number: 15892079
• Product Code: ESD
• UDI-Device Identifier: 07613389603316
• UDI-Public: (01)07613389603316
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/03/2026

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: 04/03/2026
• Initial Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/07/2026
• 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: Female