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

Model Number	078-0068
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Ear or Labyrinth Problem (4474)
Date of Event	11/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer conducted a follow up with the initial reporter.The hcp reported that the patient is a fairly new user to lyric.The initial fit was on 3-nov.The patient was later seen on 18-nov and he reported he was developing discomfort in the left ear and that the device was dead.The provider observed that the device was still at the proper insertion depth (no migration).When the provider tried to remove the lyric device, the patient reported some pain.The provider allowed the patient to try to self-remove, but the patient could not remove the device because of pain.The provider referred the patient to an ent clinic nearby, and the ent removed the device.When the device was removed, the ent reported bleeding upon removal, and patient was prescribed antibiotic drops and ear rest by the ent.The patient was not reporting any issues related to the opposite ear (right side), but the provider wanted to remove this device to examine the canal.This ear also presented difficult removal.The device was at the proper insertion depth (no migration) but there was discomfort so neither hcp nor the patient removed the device.The patient saw ent to remove this device as well.Patient was scheduled for a follow up visit at the ent office in 2 weeks.The hcp is not sure if the bleeding was related to the removal of the device, or if the ear was bleeding prior to removal.The provider does believe the lyric was likely the cause of the bleeding.The provider gave the patient the option to continue lyric use but does not recommend it after the discomfort and bleeding upon removal the patient experienced.The provider has not heard back from the patient since the incident.It is unknown to the hcp if the patient was taking any medications.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, bruising, swelling and bleeding are 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.In case bleeding, pain or discomfort occur, the patient is advised to seek hcps assistance.Bleeding, bruise, blisters as well as 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.
Event or Problem Description
It has been brought to manufacturer's attention that lyric device was removed after 15 wear days, the reason for removal being "ear irritation".Upon the removal the hcp observed bleeding, severeness rated as significant.Additional ear canal observation has been provided, that says: "sent to ent - major suction".

• 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 ; laubisrütistrasse 28; stäfa, zürich 8712 ; SZ 8712
• MDR Report Key: 23825616
• Report Number: 3005085999-2025-00044
• Device Sequence Number: 13080826
• Product Code: ESD
• UDI-Device Identifier: 07613389603286
• UDI-Public: (01)07613389603286
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 11/21/2025

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: 078-0068
• 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: 11/21/2025
• Initial Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/10/2025
• 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