PHONAK 078-0063Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613389250893), received between Jan 4, 2023 and Jul 18, 2025 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT HAS BEEN BROUGHT TO MANUFACTURER'S ATTENTION THAT THE PATIENT HAS NOTICED EXCESS FLUID COLLECTION AND WHITE, THICK DEBRIS IN THE EAR UPON REMOVAL OF THE DEVICE AND SOUGHT MEDICAL TREATMENT.

  Patient problems: Infectious Otitis Externa

  MAUDE report 22541763 ↗
• InjuryJul 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT HAS BEEN BROUGHT TO MANUFACTURER'S ATTENTION THAT THE PATIENT HAS NOTICED EXCESS FLUID COLLECTION AND WHITE, THICK DEBRIS IN THE EAR UPON REMOVAL OF THE DEVICE AND SOUGHT MEDICAL TREATMENT.

  Patient problems: Infectious Otitis Externa

  MAUDE report 22478920 ↗
• InjuryApr 3, 2024No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE LYRIC4 DEVICE HAS BEEN REMOVED FROM THE PATIENT'S EAR ON THE 66TH DAY OF WEAR. HCP NOTED THAT THE REASON FOR REMOVAL WAS DISCOMFORT. UPON REMOVAL HCP HAS REMARKED THAT THE PATIENT HAS EXPERIENCED SUDDEN HEARING LOSS WHICH MAY BE RELATED TO THE ADVANCED AGE OF THE PATIENT. THE MANUFACTURER HAS SO FAR NOT MANAGED TO RULE OUT THE CONTRIBUTING ROLE OF THE DEVICE IN THE REPORTED INCIDENT. THE CURRENT LOCATION OF THE DEVICE IN UNKNOWN. THIS IS THE INITIAL REPORT. THE FOLLOW UP IS ONGOING. SUPPLEMENTAL REPORTS WILL BE SUBMITTED UPON OBTAINING ADDITIONAL INFORMATION.

  Patient problems: Hearing Impairment

  MAUDE report 19033307 ↗
• InjuryJan 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 90-YEAR-OLD PATIENT, LONG TIME USER OF THE LYRIC DEVICE, HAD A NEW DEVICE INSERTED IN (B)(6) 2022. THE INSERTION DEPTH OF THE DEVICE IN THE EAR CANAL WAS 7MM. THE PATIENT HAS REMOVED THE DEVICE AFTER ABOUT 2 WEEKS WEARING TIME DUE TO PAIN IN THE EAR BUT DID NOT HAVE THE EAR CHECKED. ON THE (B)(6) 2022, WHEN THE PATIENT CAME TO GET THE DEVICE REPLACED, THE HCP HAS IDENTIFIED "PIT IN HIS EAR" AT ABOUT 5MM IN THE CANAL. THE PIT WAS FILLED WITH DEBRIS. THE HCP HAS REFERRED THE PATIENT TO AN OTOLARYNGOLOGIST HOWEVER, THE PATIENT WENT TO A FAMILY PHYSICIAN WHO DID NOT HAVE ANY CONCERNS ABOUT THE STATE OF THE PATIENT'S EAR. DURING THE NEXT VISIT TO HCP FOR LYRIC REPLACEMENT, THE STATE OF THE EAR HAS WORSENED. ON (B)(6) 2022, THE PATIENT HAS VISITED OTOLARYNGOLOGIST, WHO CLEARED THE DEBRIS, AND CONCLUDED THAT THE EAR CANAL HAS ERODED THROUGH CARTILAGE TO THE BONE, AND THE TISSUE WAS NECROTIC. THE PATIENT WAS DIAGNOSED BY THE OTOLARYNGOLOGIST WITH EXTERNA AUDITORY CHOLESTEATOMA, WHICH ACCORDING TO THE OTOLARYNGOLOGIST WAS CAUSED BY THE USE OF LYRIC. THE DOCTOR TREATED THE PATIENT'S EAR WITH TOPICAL ANTIBIOTIC AND INDICATED THAT IT SHOULD HEAL. HE RECOMMENDED TO STOP USING LYRIC AND FIT WI

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16094709 ↗