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

Model Number	078-0068
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
Event or Problem Description
It has been brought to manufacturer's attention that lyric device was removed, as it stopped working after 27 wear days.Upon the removal the hcp observed otitis externa.
Additional Manufacturer Narrative
The manufacturer conducted a follow up with the initial reporter.The hcp reported that throughout the couple of months that the patient was wearing lyrics, she had a few incidences of moisture build up, abrasions and bleeding.This past removal revealed bleeding and moisture ad (right) and otitis externa as (left).The patient was referred to a physician to have treatment.Once medically cleared, the patient will come back to hcp to be fit with conventional hearing aids.The hcp does not know if the diagnosis of otitis externa, subject to this report, was confirmed by the ent.The hcp has not seen the patient since then.It is also not confirmed whether the patient has been prescribed with any medications.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, including otitis externa.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.This has 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 ; laubisr[?]tistrasse 28; st[?]fa, z[?]rich 8712 ; SZ 8712
• MDR Report Key: 22872181
• Report Number: 3005085999-2025-00029
• Device Sequence Number: 5688017
• Product Code: ESD
• UDI-Device Identifier: 07613389603286
• UDI-Public: (01)07613389603286
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 08/08/2025

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: 078-0068
• 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: 08/08/2025
• Initial Report FDA Received Date: 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/04/2025
• 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: Unknown