MAUDE Adverse Event Report: SONOVA AG PHONAK LYRIC 4; AIR-CONDUCTION HEARING AID, CANAL

Model Number	078-0063
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
Manufacturer has conducted a follow up with the hcp to gather more information on the incident.It's been reported that the debris was consistent with otitis externa.The patient saw ent nurse practitioner and debris was suctioned, he was prescribed ear drops for 1 week, returned to the clinic after completion of those and had gentian violet applied to the canal.The hcp indicated that patient opted to continue with lyric after obtaining medical clearance for now, as it is his preferred device.New lyric device inserted.The patient is coming to the clinic later this month to discuss daily wear alternative given that this is the second occurrence of otitis externa.He has had one other episode since starting lyric around 15 months ago.Patient did not report pain or note drainage until clinician observed it.The hcp felt that it was likely that the condition was due to lyric use.Medical provider has advised to discontinue lyric once daily wear selection is made.The device is not available for analysis.The risk of accumulation of moisture in the ear due to device's design and sealed fit in the ear has been already considered in the accompanying risk file.The ifu accompanying the device lists actions to take when ear pain, irritation or inflammation occurs and seeking medical advice referral criteria.This is the final report.
Event or Problem Description
It has been brought to manufacturer's attention that the patient has noticed excess fluid collection and white, thick debris in the ear upon removal of the device and sought medical treatment.

• Brand Name: PHONAK LYRIC 4
• Common Device Name: AIR-CONDUCTION HEARING AID, CANAL
• Manufacturer (Section D): SONOVA AG; laubisrütistrasse 28; stäfa, zürich 8712 ; SZ 8712
• Manufacturer Contact: aleksandra enns-bray ; laubisrütistrasse 28; stäfa, zürich 8712 ; SZ 8712
• MDR Report Key: 22478920
• Report Number: 3005085999-2025-00016
• Device Sequence Number: 12748302
• Product Code: ESD
• UDI-Device Identifier: 07613389250893
• UDI-Public: (01)07613389250893
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/02/2025

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: 078-0063
• 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: 07/02/2025
• Initial Report FDA Received Date: 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/22/2024
• 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