PHONAK 078-0065Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613389250916), received between Jan 23, 2024 and Feb 20, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 20, 2024No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  HCP HAS REPORTED THAT A PATIENT EXPERIENCED SUDDEN REDUCTION IN HEARING. CURRENTLY THE DEVICE RELATEDNESS OF THE INCIDENT HAS NOT BEEN CONFIRMED. A FOLLOW UP IS ONGOING TO COLLECT FURTHER INFORMATION ABOUT THE INCIDENT. THIS IS AN INITIAL REPORT. FOLLOW UP REPORTS WILL BE SUBMITTED UPON AVAILABILITY OF FURTHER INFORMATION.

  Patient problems: Partial Hearing Loss

  MAUDE report 18740136 ↗
• InjuryJan 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPON REMOVAL OF THE LYRIC DEVICE THE HCP HAS REFERRED PATIENT TO ENT DUE TO POSTERIOR TEMPANIC MEMBRANE PERFORATION AND KERATIN DEBRIS IN THE MIDDLE EAR SPACE. CURRENTLY, THE MANUFACTURER COULD NOT CONFIRM THAT THE DEVICE DID NOT CONTRIBUTE TO THE INCIDENT. THIS IS THE INITIAL REPORT. THE FOLLOW UP IS ONGOING. SUPPLEMENTAL REPORTS WILL BE SUBMITTED UPON AVAILABILITY OF FURTHER INFORMATION.

  Patient problems: Perforation

  MAUDE report 18564505 ↗