GN ReSound KE3ITC-DW-MPRecalls & reported problems
Gn Hearing A/S · HI,KE3ITC-DW-MP · Class 2
All models of GN ReSound (106)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05708296207527), received between Mar 1, 2024 and Nov 14, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
- Fracture1
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 14, 2024Break; Break
ESTIMATED DATE OF INCIDENT (B)(6) 2024 IT WAS REPORTED THAT THE WAX FILTER OF A HEARING AID BROKE. NO HARM TO THE USER WAS REPORTED. FURTHER FOLLOW UP IS EXPECTED. 09DEC2024: NO FURTHER FOLLOW UP IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20681693 ↗MalfunctionOct 31, 2024Use of Device Problem; Use of Device Problem
MANUFACTURER'S REFERENCE NUMBER (B)(4). IT WAS REPORTED THAT THE WAX BUSTER FELL OFF A HEARING AID WHILE THE USER WAS WIPING IT OVER TO CLEAN. THE OBJECT DID NOT REQUIRE REMOVAL AND THE EVENT HAS NOT CAUSED HARM. NO FURTHER FOLLOW UP IS EXPECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20577300 ↗MalfunctionMar 15, 2024Fracture; Fracture
ESTIMATED DATE OF INCIDENT ON (B)(6) 2024 IT WAS REPORTED THAT LEFT SHELL IS BROKEN NEAR THE CANAL PART. NO HARM TO THE USER HAS BEEN REPORTED. FURTHER FOLLOW UP IS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18910563 ↗MalfunctionMar 1, 2024Break; Break
ESTIMATED DATE OF INCIDENT ON (B)(6) 2024 IT WAS REPORTED THAT THE SHELL WAS BROKEN ON AN IN-THE-CANAL HEARING AID. NO FURTHER FOLLOW UP IS EXPECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18814875 ↗
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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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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