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

Model Number	078-0067
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer conducted an investigation.Follow up: it is suspected that the ingestion of the lyric device happened on (b)(6) 2025.The family took the patient to the emergency department of the local hospital.The device was confirmed ingested by x-ray.The doctor consulted with a gi and they agreed that it was okay to let the device pass and no major surgery was needed.No medication was prescribed.The device passed through the patient's system and the patient is doing well.A relative of the patient said that the patient confused lyric with medication and accidently swallowed it.The patient has no coexisting conditions.Manufacturer analysis: the intended use of the device requires it to be small in size, so that it can be worn in the ear and the device contains build-in zinc-air battery, which is required for device to power up and function.Due to this, device ingestion is a known and inherited risk of the device.Product's risk management file contains a risk item addressing this hazard and implements warnings.The manufacturer deemed that the benefit of the device outweighs the risk.The manufacturer checked device labelling.The accompanying user guide contains several information and warnings about that the device contains zinc-air battery and warns the user against swallowing the device as well as what to do if the device was ingested incl.A phone number to the 24-hour national battery ingestion hotline.The packaging includes a symbol meaning "do not ingest the contents of the two packets.".The manufacturer checked for similar incidents and there have been no other instances of ingested lyric devices recorded in the last 5 years.The manufacturer will monitor for trends.This is combined initial & final report.
Event or Problem Description
It was reported to the manufacturer that a patient ingested lyric hearing aid.

• Brand Name: PHONAK LYRIC4
• Common Device Name: HEARING AID, COMPLETELY-IN-CANAL
• Manufacturer (Section D): SONOVA AG; laubisrütistrasse 28; stäfa, zürich 8712 ; SZ 8712
• Manufacturer Contact: aleksandra enns-bray ; laubisrütistrasse 28; stäfa, zürich 8712 ; SZ 8712
• MDR Report Key: 22606862
• Report Number: 3005085999-2025-00020
• Device Sequence Number: 14798842
• Product Code: ESD
• UDI-Device Identifier: 07613389603279
• UDI-Public: (01)07613389603279
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 07/16/2025

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: 07/16/2025
• Initial Report FDA Received Date: 07/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/27/2025
• 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