MAUDE Adverse Event Report: SONOVA AG PHONAK LYRIC4; AIR-CONDUCTION HEARING AID, 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
Additional Manufacturer Narrative
Manufacturer has conducted a follow up with the hcp to gather more information on the incident.It's been reported that the patient was referred to the ent after the device was removed and otoscopy was performed.The ent diagnosed "possible polyp" with "granulation" the ent prescribed ciprodex drops.The ent does relate the condition with the use of the lyric device.The ent recommended 6 weeks of ear rest.Hcp will evaluate and possibly refit lyric at that time.The device is not available for analysis.Medial ear canal growth / bulge / polyp is a symptom already identified and addressed in the clinical evaluation report of lyric device.It is known to be usually resolved with rest, not requiring medical treatment.Lyric device, as intended is a device to be inserted in the ear canal.It can create some pressure and friction onto the skin.Such pressure and friction can cause minor soft tissue injury.Although the wounds are expected to heal normally after the removal of the device, in some cases this may require additional treatment.The risks of both self-resolving and non-self-resolving tissue injury resulting from the use of the device are already covered within the risk management file of the device.The ifu accompanying the device contains appropriate warning referring the patient to see the hcp when experiencing pain in or behind the ear.This is the final report.
Event or Problem Description
It has been brought to manufacturer's attention that the lyric device was proactively removed after 42 wear days.Upon the removal the hcp noticed a medial bulge / growth in patient's ear and referred the patient to the ent for assessment.

• Brand Name: PHONAK LYRIC4
• Common Device Name: AIR-CONDUCTION HEARING AID, CANAL
• Manufacturer (Section D): SONOVA AG; laubisruetistrasse 28; staefa, zurich 8712 ; SZ 8712
• Manufacturer Contact: aleksandra enns-bray ; laubisr[?]tistrasse 28; st[?]fa, z[?]rich 8712 ; SZ 8712
• MDR Report Key: 22871769
• Report Number: 3005085999-2025-00028
• Device Sequence Number: 16024962
• Product Code: ESD
• UDI-Device Identifier: 07613389603323
• UDI-Public: (01)07613389603323
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 08/07/2025

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: 078-0072
• 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: 08/07/2025
• Initial Report FDA Received Date: 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/05/2025
• 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