GN Hearing 21384500Recalls & reported problems
Gn Hearing A/S · REC TMRIE,SF3 LP,2L,BLSTR · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- 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 05708296219339), received between Jul 25, 2024 and Jul 25, 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
- Product Quality Problem1
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.
MalfunctionJul 25, 2024Product Quality Problem; Detachment of Device or Device Component; Product Quality Problem; Detachment of Device or Device Component
IT WAS REPORTED THAT ON 03JUN2024 THE RECEIVER OF THE HEARING AID WAS BROKEN AND WHEN IT WAS REPLACED THE HEARING CARE PROFESSIONAL CHECKED THAT THE HEARING AID DIDN'T CHARGE (AND USER SAID IT DIDN'T WORK CORRECTLY). AFTER BEING ASKED ABOUT HOW THE RECEIVER WAS BROKEN, THE HEARING CARE PROFESSIONAL THINKS THAT IS LIKELY THAT IT OCCURRED WHEN THE HEARING INSTRUMENT WENT TO BE WORN/UNWORN DUE TO THE WEAR. THE OBJECT DID NOT REQUIRE REMOVAL AND NO HARM TO THE USER WAS REPORTED. NO FURTHER FOLLOW UP IS EXPECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19826618 ↗
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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page