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

Model Number	078-0072
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Ear or Labyrinth Problem (4474)
Type of Reportable Event	Serious Injury
Event or Problem Description
It has been brought to manufacturer's attention that there was a fitting/removal related issue with a lyric device.It is said the reason for device removal was migration and that sore and ulceration of tissue with severeness rated as mild was observed upon.
Additional Manufacturer Narrative
The manufacturer conducted a follow up with the initial reporter.The hcp reported that after the device removal patient's left ear canal had an erosion of fibroma and so he was told to keep the device out.Patient has seen a physician who diagnosed erosion of fibroma' and prescribed ciprodex ear drops and advised to put the ear on rest.Patient's eardrum looked intact and normal.The patient was on antibiotic for five days.They did not show up for the follow up appointment, it's then unknown if the ear healed by now.Follow up interview with the hcp established that the hcp relates the erosion of fibroma to the use of lyric.Based on the physician's report, the erosion of fibroma resulted from wearing lyric.It has been reported that the device was removed from the patient's ear by the physician's assistant.There are no notes related to difficult removal.No lubrication was used.It is unknown to the hcp whether the patient had any issues with lyric prior to the visit at the office.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.This environment can occasionally result in skin irritations or infections.Related to the deep inserted extended wear of lyric, symptoms such as abrasions, bleeding, ulcers and infections tend to occur most commonly as a result of traumatic insertion, sizing error, poor placement or patient manipulation.Sore / ulceration of tissue is considered a soft tissue injury which is a known side effect of lyric addressed both in the clinical evaluation and risk management file of the device.The self-removal instruction is given in the device's ifu.It is said to use a gentle circular motion to remove the hearing aid.Ear infection and other symptoms related to the deep insertion of lyric have 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.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 ; laubisruetistrasse 28; staefa, zurich 8712 ; SZ 8712
• MDR Report Key: 23755556
• Report Number: 3005085999-2025-00042
• Device Sequence Number: 14958432
• Product Code: ESD
• UDI-Device Identifier: 07613389603323
• UDI-Public: (01)07613389603323
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 11/13/2025

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: 078-0072
• 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: 11/13/2025
• Initial Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/28/2025
• 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