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

Model Number	078-0060
Medical Device Problem Codes	Moisture or Humidity Problem (2986); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Hematoma (1884); Ear Pain (4812); Middle Ear Inflammation (4816)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is an innitial report.Manufacturer has requested for the device to be returned.Follow up will be submitted upon availability of any additional information.
Event or Problem Description
The hcp reported that the patient has lyric device fitted.The fitting went well.The patient went swimming with lyric and earplug as well as jogging with headset.Afterwards, the patient felt pain in the ear with lyric.The patient removed device by himself.The patient has hematoma and otitis in the ear and receives medication.The device was used for 24 days.
Additional Manufacturer Narrative
The follow up determined that the patient visited a medical doctor after the incident and was prescribed oflocet (ofloxacin, antibiotic).The patient started using lyric again shortly after the incident against the hcp's advice.The hcp inserted the new device at its minimum depth due to hematoma still being present in patient's ear.At the next visit with the hcp, it is planned to insert lyric at the full depth in the patient's ear.The reported device was discarded and is not available for the analysis.There were no prior complaints made for the patient's device.Based on the incident description, it is plausible that submerging device in water led to water accumulation in the ear, which contributed to otitis in the patient's ear.Risk management file already considers a risk of bacteria growth leading to skin irritation and/or infection due to accumulation of moisture or fluid.The design of the device, specifically the seals properties, allows for moisture vapour transmission in order to minimize the risk of moisture accumulation in the device.The user guide contains information about lyric being water resistant and not water proof, and an information recommending patient against submerging lyric.The manufacturer recorded only one similar complaint between jan 2022 and sept 2024 related to moisture accumulation due to swimming, where the patient did not require medical intervention and recovered after ear rest.The manufacturer will observe for trends.This is the final report.
Event or Problem Description
The hcp reported that the patient had lyric device fitted.The fitting went well.The patient went swimming with lyric and custom made earplug and later jogging with a headset.Afterwards, the patient felt pain in the ear with lyric.The patient removed device by himself.The patient had hematoma and otitis in the ear and receives antibiotics (ofloxacin).The device was used for 24 days.

• Brand Name: PHONAK LYRIC4 (XXS)
• Common Device Name: HEARING AID, COMPLETELY-IN-CANAL
• Manufacturer (Section D): SONOVA AG; laubisrütistrasse 28; stafa, zurich 8712 ; SZ 8712
• Manufacturer Contact: minal maurya ; 750 n commons dr; aurora, IL 60504 ; 6308219589
• MDR Report Key: 19990012
• Report Number: 3005085999-2024-00017
• Device Sequence Number: 7087377
• Product Code: ESD
• UDI-Device Identifier: 07613389250862
• UDI-Public: (01)07613389250862
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: NA
• 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,Followup
• Report Date (Section B): 07/25/2024

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: 078-0060
• 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: 07/25/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/15/2024
• Supplement Report FDA Received Date: 10/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/14/2024
• 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