GN Hearing 21385700Recalls & reported problems
Gn Hearing A/S · REC TMRIE,SF3 MP,3L,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 05708296219452), received between Aug 23, 2024 and Aug 23, 2024 — 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
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 23, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
22-AUG-2024: IT WAS REPORTED THAT A PIECE OF RECEIVER STUCK IN EAR. USER HAD TO GO TO THE EMERGENCY ROOM BECAUSE A PIECE OF THE RECEIVER CAME LOOSE AND GOT STUCK IN HIS EAR. IT WAS REPORTED THERE WAS NO HARM TO THE USER. NO FURTHER FOLLOW UP EXPECTED.
Patient problems: Foreign Body In Patient
MAUDE report 20046554 ↗
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.