PHONAK 078-0060Recalls & reported problems
Sonova AG · Lyric4 (XXS) · Class 1
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613389250862), received between Jul 10, 2024 and Aug 25, 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem3
- Insufficient Device Problem Information1
- Moisture or Humidity Problem1
Patient problems
- Blister2
- Itching Sensation2
- Skin Tears2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Ear Pain1
- Hematoma1
- Middle Ear Inflammation1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryAug 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED TO THE MANUFACTURER THAT A PATIENT USING LYRIC HEARING AID EXPERIENCE EAR BLEEDING DURING DEVICE REMOVAL BY THE HCP.
Patient problems: Blister; Itching Sensation; Skin Tears
MAUDE report 22883624 ↗InjuryJul 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED TO THE MANUFACTURER THAT A PATIENT USING LYRIC HEARING AID EXPERIENCE EAR BLEEDING DURING DEVICE REMOVAL BY THE HCP.
Patient problems: Blister; Itching Sensation; Skin Tears
MAUDE report 22663417 ↗InjuryAug 15, 2024Moisture or Humidity Problem; Insufficient Device Problem Information; Moisture or Humidity Problem; Insufficient Device Problem Information
THE HCP REPORTED THAT THE PATIENT HAS LYRIC DEVICE FITTED. THE FITTING WENT WELL. THE PATIENT WENT SWIMMING WITH LYRIC AND EARPLUG AS WELL AS JOGGING WITH HEADSET. AFTERWARDS, THE PATIENT FELT PAIN IN THE EAR WITH LYRIC. THE PATIENT REMOVED DEVICE BY HIMSELF. THE PATIENT HAS HEMATOMA AND OTITIS IN THE EAR AND RECEIVES MEDICATION. THE DEVICE WAS USED FOR 24 DAYS.
Patient problems: Ear Pain; Hematoma; Middle Ear Inflammation
MAUDE report 19990012 ↗InjuryJul 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SONOVA AG IS INFORMED BY THE HEALTH CARE PROFESSIONAL THAT THE LISTED DEVICE HAS BEEN INVOLVED IN AN INCIDENT LEADING TO TM PERFORATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 19712583 ↗
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 (XXS)Sonova AG · Hearing Aid, Air-Conduction, Prescription6 reports
- Phonak Lyric4 (XL)Sonova AG · Hearing Aid, Air-Conduction, Prescription6 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 078-0063Sonova AG · Hearing aid, air conduction4 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.