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

Model Number	078-0067
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
Additional Manufacturer Narrative
The manufacturer conducted a follow up with the initial reporter.The hcp reported that the patient removed lyric roughly from own ear that had narrow ear canal.Patient had admitted that she should have been gentler and that is when bleeding began.The hcp indicated that they let ear heal and she inserted new lyric even though there was still dried blood in canal, and feedback started immediately.The hcp reported that patient went to ent who prescribed 6 weeks of antibiotics.The hcp admits she doesn't have a working relationship with the ent clinic the patient attended therefore, the hcp is not be able to get the information on the ent diagnosis.Patient reported having exposed bone on the floor of the canal and the ent found the area to be slightly infected.The hcps diagnosis was only the patients general h90.3 for her sensorineural hearing loss.The hcp is not sure what type of infection the patient had.The hcp relates the incident to the use of lyric.Despite the narrow ear canal, the patient had lyrics for at least 2 years.The hcp reports the patient used them faithfully however the left ear always gave issues during insertion and removal.If it was not placed "just right" it would cause feedback or discomfort.That ear also produced more cerumen build up than the right ear.The patient and the hcp decided that once the ear is completely healed and cleared by ent, the patient will switch to daily wear hearing aids.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, creating a moist and dark environment that is conducive to bacterial growth.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 otitis externa tend to occur most commonly as a result of traumatic insertion, sizing error, poor placement or patient manipulation.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.It should be also noted that otitis externa is a relatively common condition that can occur independently of hearing aid use.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 20 wear days.Upon the removal the hcp observed blood in the ear canal.

• 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 ; laubistruetistrasse 28; staefa, zurich 8712 ; SZ 8712
• MDR Report Key: 23378747
• Report Number: 3005085999-2025-00034
• Device Sequence Number: 15753555
• Product Code: ESD
• UDI-Device Identifier: 07613389603279
• UDI-Public: (01)07613389603279
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 10/07/2025

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: 078-0067
• 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: 10/07/2025
• Initial Report FDA Received Date: 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/29/2025
• 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: Female