GN Hearing 21385600Recalls & reported problems
Gn Hearing A/S · REC TMRIE,SF3 MP,2R,BLSTR · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05708296219445), received between Oct 25, 2024 and Jul 25, 2025 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 reports).
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 Component3
- Product Quality Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ESTIMATED DATE OF INCIDENT ON (B)(6) 2025. IT HAS BEEN REPORTED THAT A HEARING AID RECEIVER BROKE. IT IS UNKNOWN IF THE RECEIVER BROKE WHILE INSIDE THE EAR, BUT THERE IS NO REPORT OF ANY HARM TO THE USER NO FURTHER FOLLOW UP IS AVAILABLE OR EXPECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22606657 ↗InjuryNov 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ON AN UNKNOWN DATE (ESTIMATED DATE 28-OCT-2024) A HEARING AID SF3 RECEIVER BROKE IN HALF. THE ELECTRONIC PART LODGED IN USERS EAR CANAL. THE OBJECT WAS REMOVED BY THE HEARING CARE PROVIDER WHO IS ALSO QUALIFIED IN EAR WAX REMOVAL. THE HEARING AID WAS NOT USED WITH A SPORTS LOCK. USER HAVE NOT BEEN IN CONTACT WITH ANY OTHER MEDICAL PRACTITIONER THAN THE HEARING CARE PROVIDER. HEARING CARE PROVIDER CONFIRMED NO HARM CAME TO USER. NO FURTHER FOLLOW UP EXPECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20795956 ↗MalfunctionOct 25, 2024Product Quality Problem; Detachment of Device or Device Component; Product Quality Problem; Detachment of Device or Device Component
ESTIMATED DATE OF INCIDENT (B)(6) 2024 IT WAS REPORTED THAT A HEARING AID RECEIVER BROKE. IT IS UNKNOWN WHETHER IT BROKE INSIDE OR OUTSIDE THE EAR. NO HARM TO THE USER HAS BEEN REPORTED. NO FURTHER FOLLOW UP IS AVAILABLE OR EXPECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20531432 ↗
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.
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