PHONAK 078-0062Recalls & reported problems
Sonova AG · Lyric4 (S) · Class 1
All models of PHONAK (13)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613389250886), received between Jan 18, 2024 and Apr 30, 2025 — classified as 3 injuries, 1 malfunction.
The most frequently reported specific device problem is “Output Problem” (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. 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 Problem2
- Output Problem1
- Overheating of Device1
Patient problems
- Ear infection2
- Fluid Discharge1
- No Clinical Signs, Symptoms or Conditions1
- Unspecified Ear or Labyrinth Problem1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryApr 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED TO THE MANUFACTURER THAT DARK GREEN FLUID WAS OBSERVED IN THE PATIENT'S EAR CANAL UPON LYRIC REMOVAL. THE DEVICE WAS IN USE FOR 53 DAYS AND WAS REMOVED DURING A SCHEDULED REMOVAL APPOINTMENT. THE HCP IS SUSPECTING AN INFECTION AND HAD REFERRED THE PATIENT TO THE ENT BEFORE THE PLACEMENT OF A NEW LYRIC DEVICE.
Patient problems: Ear infection; Fluid Discharge
MAUDE report 21933768 ↗InjuryFeb 11, 2025Output Problem; Output Problem
DEVICE WAS FIT ON (B)(6) 2025 AND WAS IN USE FOR 7 DAYS. DEVICE BECAME WEAK AND WAS REMOVED FROM THE PATIENT'S EAR. UPON REMOVAL EXCESS FLUID COLLECTION IN PATIENT'S EAR WAS OBSERVED. THE FLUID WAS WHITE AND SOMEHOW THICK. THE PATIENT WENT TO THE URGENT CARE TO EXAMINE THE EAR AND IS RECEIVING ANTIBIOTIC DROPS.
Patient problems: Ear infection
MAUDE report 21354790 ↗InjuryJan 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE HCP HAS REPORTED THAT A PATIENT HAS DISCONTINUED THE USE OF LYRIC4 DEVICE DUE TO BONE EXPOSURE IN THE RIGHT EAR. THE PATIENT WILL CONTINUE USING THE DEVICE IN THE LEFT EAR. THE DEVICE RELATEDNESS OF THE EVENT COULD NOT BE CLARIFIED PRIOR TO REPORT SUBMISSION. THE FOLLOW UP IS ONGOING. SUPPLEMENTAL REPORTS WILL BE SUBMITTED UPON AVAILABILITY OF FURTHER INFORMATION.
Patient problems: Unspecified Ear or Labyrinth Problem
MAUDE report 18564654 ↗MalfunctionJan 18, 2024Overheating of Device; Overheating of Device
IT HAS BEEN REPORTED THAT A PHONAK MINI CHARGER CASE HAS OVERHEATED AND LEAD TO A MINOR DAMAGE OF THE USER'S NIGHT TABLE. NO INJURY TO THE USER OR THIRD PARTY HAS BEEN REPORTED. THE CUSTOMER WILL RECEIVE A COMPENSATION FOR THE DAMAGE. THE DEVICE HAS NOT BEEN RECEIVED BACK FOR ANALYSIS. SIMILAR EVENTS WILL BE FURTHER MONITORED FOR TRENDS. THIS IS A LATE REPORT THAT COMES TO OUR ATTENTION AS A RESULT OF AN IMPROVEMENT TO THE COMPLAINT HANDLING PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18535711 ↗
Other Hearing aid, air conduction 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 Lyric4 (XL)Sonova AG · Hearing Aid, Air-Conduction, Prescription6 reports
- PHONAK 078-0060Sonova 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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