MAUDE Adverse Event Report: SONOVA AG PHONAK LYRIC4 (S); HEARING AID, COMPLETELY-IN-CANAL

Model Number	0780069
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 was reported to the manufacturer that the patient using lyric device experienced redness of tissue in the ear.
Additional Manufacturer Narrative
Lyric was worn for 62 days and was removed during a scheduled device removal.The follow up with hcp revealed that the ent physician diagnosed the patient with otitis externa infection.The patient was prescribed antibiotic ear drops.The hcp saw the patient recently and otoscopy showed the canal is still red, but the ear canal looks much better and is healing.The patient is doing well.Lyric is worn completely invisible in the ear canal.In order to achieve its intended purpose (and therefore the clinical benefit), soft foam components (seals) are used in different sizes to enable an ideal fit in an individual's ear canal.The sealing of the ear canal might lead to a moisture accumulation in the volume between device and ear drum which could lead to skin injuries.The compromised skin integrity, the moist and dark environment promotes bacterial infection, which could occasionally cause skin irritations and/or infections like otitis externa, which is a common ear condition also among non-hearing aid users.Full recovery is expected.The risk of accumulation of moisture in the ear due to device's design and sealed fit in the ear as well as the risk of device movement due to improper fit leading to touching ear drum have been already considered in the accompanying risk file.The ifu contains information about common side effects such as e.G.Ear pain, moisture and blisters, as well as information on contraindications and referral criteria.The manufacturer did not record any complaint trends for this issue on the market so far.The manufacturer will keep monitor for trends.

• Brand Name: PHONAK LYRIC4 (S)
• Common Device Name: HEARING AID, COMPLETELY-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: 22749484
• Report Number: 3005085999-2025-00025
• Device Sequence Number: 8598853
• Product Code: ESD
• UDI-Device Identifier: 07613389603293
• UDI-Public: 07613389603293
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 07/29/2025

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: Health Professional
• Device Model Number: 0780069
• 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: 07/29/2025
• Initial Report FDA Received Date: 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/21/2025
• 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