PHONAK 078-0061Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613389250879), received between Dec 4, 2024 and Feb 11, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DEVICE WAS IN USE FOR 59 DAYS. THE DEVICE WAS REMOVED FROM THE PATIENT'S EAR DURING A SCHEDULED REMOVAL APPOINTMENT. AFTER THE REMOVAL, THE ENT OBSERVED INFECTION IN THE PATIENT'S EAR. THE PATIENT WAS PRESCRIBED ANTIBIOTICS TO TREAT THE EAR.

  Patient problems: Infectious Otitis Externa

  MAUDE report 21355072 ↗
• InjuryDec 13, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT HAS BEEN REPORTED THAT THE DEVICE GOT STUCK AND A FRONT PANEL CAME OFF DURING THE PROCEDURE OF SCHEDULED REMOVAL BY THE HCP. THE PATIENT WAS SENT TO ENT, WHO REMOVED THE DEVICE AND TREATED TRAUMA.

  Patient problems: Foreign Body In Patient

  MAUDE report 20922440 ↗
• InjuryDec 4, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT HAS BEEN REPORTED THAT ON THE HCP'S ATTEMPT TO REMOVE LYRIC FROM A PATIENT'S EAR, PART OF THE DEVICE TOTALLY SNAPPED OFF AND THE HCP WAS UNABLE TO REMOVE THE DEVICE FROM PATIENT'S EAR. THE PATIENT WAS SENT FOR AN URGENT PRIVATE ENT APPOINTMENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 20840597 ↗