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

Model Number	0780071
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
Additional Manufacturer Narrative
The manufacturer initiated a follow up with the initial reporter.The hcp reported that the patient was diagnosed with acute otitis externa in the right ear.There were no signs of ear health issues prior to the hearing aid fitting.Lyric was worn for 28 days prior to this event.The patient was treated with antibiotics ear drops (neomycin-polymyxin-hydrocort 3.5 mg10,000 unit/ml-1 %).The patient recovered and was scheduled to return for lyric refit on the day of this follow up.The hcp does not relate this incident to the use of lyric.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.Therefore, while the hcp does not link the incident to the device, the design and function of the device may contribute to conditions that could lead to such infections.This has already been considered in the device's risk file.The ifu accompanying the device lists actions to take when ear pain, irritation or inflammation occurs and seeking medical advice referral criteria.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.
Event or Problem Description
The manufacturer was notified that the hcp observed drainage in the patient's ear and referred the patient to an ent doctor.

• Brand Name: PHONAK LYRIC4 (L)
• 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: 22850150
• Report Number: 3005085999-2025-00026
• Device Sequence Number: 19948682
• Product Code: ESD
• UDI-Device Identifier: 07613389603316
• UDI-Public: 07613389603316
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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): 08/01/2025

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: 0780071
• 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: 08/01/2025
• Initial Report FDA Received Date: 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/22/2025
• 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