Phonak Lyric4 (XL)Recalls & reported problems
Sonova AG · Class 1
All models of Phonak Lyric4 (6)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613389603323), received between Aug 22, 2025 and Dec 12, 2025 — classified as 6 injuries.
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem6
Patient problems
- Unspecified Ear or Labyrinth Problem4
- Ear infection2
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryDec 12, 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 THERE WAS A FITTING/REMOVAL RELATED ISSUE WITH A LYRIC DEVICE. IT IS SAID THE REASON FOR DEVICE REMOVAL WAS MIGRATION AND THAT SORE AND ULCERATION OF TISSUE WITH SEVERENESS RATED AS MILD WAS OBSERVED UPON.
Patient problems: Unspecified Ear or Labyrinth Problem
MAUDE report 23790412 ↗InjuryDec 9, 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 THERE WAS A FITTING/REMOVAL RELATED ISSUE WITH A LYRIC DEVICE. IT IS SAID THE REASON FOR DEVICE REMOVAL WAS MIGRATION AND THAT SORE AND ULCERATION OF TISSUE WITH SEVERENESS RATED AS MILD WAS OBSERVED UPON.
Patient problems: Unspecified Ear or Labyrinth Problem
MAUDE report 23755556 ↗InjuryAug 28, 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 LYRIC DEVICE WAS PROACTIVELY REMOVED AFTER 42 WEAR DAYS. UPON THE REMOVAL THE HCP NOTICED A MEDIAL BULGE / GROWTH IN PATIENT'S EAR AND REFERRED THE PATIENT TO THE ENT FOR ASSESSMENT.
Patient problems: Unspecified Ear or Labyrinth Problem
MAUDE report 22918924 ↗InjuryAug 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT HAS BEEN REPORTED THAT LYRIC DEVICE WAS REMOVED AFTER 12 WEAR DAYS. UPON THE REMOVAL THE HCP OBSERVED SIGNIFICANT REDNESS OF TISSUE, EAR CANAL BLEEDING AND RETRACTION OF TYMPANIC MEMBRANE.
Patient problems: Ear infection
MAUDE report 22917411 ↗InjuryAug 27, 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 LYRIC DEVICE WAS REMOVED AFTER 12 WEAR DAYS. UPON THE REMOVAL THE HCP OBSERVED SIGNIFICANT REDNESS OF TISSUE, EAR CANAL BLEEDING AND RETRACTION OF TYMPANIC MEMBRANE.
Patient problems: Ear infection
MAUDE report 22901887 ↗InjuryAug 22, 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 LYRIC DEVICE WAS PROACTIVELY REMOVED AFTER 42 WEAR DAYS. UPON THE REMOVAL THE HCP NOTICED A MEDIAL BULGE / GROWTH IN PATIENT'S EAR AND REFERRED THE PATIENT TO THE ENT FOR ASSESSMENT.
Patient problems: Unspecified Ear or Labyrinth Problem
MAUDE report 22871769 ↗
Other Hearing Aid, Air-Conduction, Prescription devices
- Phonak Lyric4 (L)Sonova AG · Hearing Aid, Air-Conduction, Prescription14 reports
- Phonak Lyric4 (S)Sonova AG · Hearing Aid, Air-Conduction, Prescription11 reports
- Phonak Lyric4 (M)Sonova AG · Hearing Aid, Air-Conduction, Prescription7 reports
- Phonak Lyric4 (XS)Sonova AG · Hearing Aid, Air-Conduction, Prescription6 reports
- GN Hearing 21385500Gn Hearing A/S · Hearing Aid, Air-Conduction, Prescription6 reports
- Phonak Lyric4 (XXS)Sonova AG · Hearing Aid, Air-Conduction, Prescription6 reports
- PHONAK 078-0060Sonova AG · Hearing aid, air conduction4 reports
- PHONAK 078-0062Sonova AG · Hearing aid, air conduction4 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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