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

Model Number	0780060
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Itching Sensation (1943); Skin Tears (2516); Blister (4537)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to the manufacturer that a patient using lyric hearing aid experience ear bleeding during device removal by the hcp.
Additional Manufacturer Narrative
The follow up with the hcp established the following: the patient came to the hcp and reported the device was causing significant itching and requested that it be removed.The hcp was able to remove it very gently and without incident.The ear began bleeding.The hcp believes that the removal went well.The patient had a similar reaction when lyric was removed from the other ear in the past.The hcp believes the patient had a blood blister that ruptured.She referred the patient to an ent.However, the patient is a physician and said that he has some leftover antibiotic that he would use.The hcp strongly advised against that and preferred the patient sees an ent instead.The patient desires to continue with lyric once the ear has healed.The hcp will see him again in about 4 weeks.Device investigation: the device was worn by the patient for 14 days before the removal and is not available for an analysis.Lyric is worn completely invisible in the ear canal.In order to achieve its intended purpose (and therefore the clinical benefit), soft foam components (seals) are used in different sizes to enable an ideal fit in an individual's ear canal.It is designed for single insertion and shall not be reused once removed from the ear.While the device is worn as intended, it can create some pressure and friction onto the skin, which can cause a self-resolving or non-self-resolving soft tissue injury, which does not heal normally after removal of the device and requires medical intervention.The injury is not life-threatening and a full recovery is expected.The risk file already addresses the risk of self-resolving and non-self-resolving soft tissue injuries.Based on clinical evaluation, bleeding can most likely occur due to traumatic insertion, sizing error, poor placement or patient manipulation.Bleeding is often self-resolved by allowing the ear to rest before insertion.The user guide advises patient to consult a hcp if they experience pain beyond the initial minimal discomfort, if the ear is inflamed or skin irritation occurs.The manufacturer is observing for trends.

• Brand Name: LYRIC4 (XXS)
• Common Device Name: HEARING AID, COMPLETELY-IN-CANAL
• Manufacturer (Section D): SONOVA AG; laubisruetistrasse 28; stafa, zurich 8712 ; SZ 8712
• Manufacturer Contact: aleksandra enns-bray ; laubisruetistrasse 28; stafa, zurich 8712 ; SZ 8712
• MDR Report Key: 22663417
• Report Number: 3005085999-2025-00022
• Device Sequence Number: 12664379
• Product Code: ESD
• UDI-Device Identifier: 07613389250862
• UDI-Public: 07613389250862
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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): 07/28/2025

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: 0780060
• 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: 07/28/2025
• Initial Report FDA Received Date: 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/06/2025
• 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