GN Hearing 21385200Recalls & reported problems
Gn Hearing A/S · REC TMRIE,SF3 MP,0R,BLSTR · Class 1
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05708296219407), received between Apr 24, 2025 and Apr 24, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT HAS BEEN REPORTED THAT A RECEIVER BROKE WHILE IN THE EAR CANAL AND GOT STUCK. THE USER WAS ABLE TO REMOVE IT HIMSELF, AND NO HARM RESULTED FROM THE INCIDENT. NO FURTHER FOLLOW UP IS EXPECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21898146 ↗
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 (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.