GN Otometrics A/S AURICALRecalls & reported problems
Natus Medical Denmark ApS · 1081 AURICAL AUD with HI-PRO (US only) Incl. Bone conductor/Insert Phone and TDH Headset · Class 2
All models of GN Otometrics A/S (6)
Data updated Oct 16, 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 05713315004049), received between Mar 16, 2022 and Mar 16, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Electrical /Electronic Property Problem1
- Electrostatic Discharge1
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.
MalfunctionMar 16, 2022Electrical /Electronic Property Problem; Electrostatic Discharge; Electrostatic Discharge
CALLER REPORTS THEY FELT A STATIC SHOCK FROM THE DISPENSER MONITOR HEADSET AND NOW THE TALK FORWARD PORTION OF THE HEADSET IS NOT WORKING. THEY TRIED A KNOWN WORKING HEADSET IN THIS BOOTH, AND IT DOES NOT WORK IN THIS BOOTH, ONLY THE AUDIO WORKS ON THE HEADSET, NOT THE MICROPHONE PART. BOTH HEADSETS WORK FULLY IN THE OTHER BOOTH. THE CALLER BELIEVES THAT THE AURICAL ITSELF GOT PHYSICALLY DAMAGED WHEN THEY FELT THE STATIC SHOCK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13787420 ↗
Other Audiometer devices
- Sentiero 100098PATH medical GmbH · Audiometer1 recall0 reports
- Sentiero 100098-SPATH medical GmbH · Audiometer1 recall0 reports
- Sentiero 100098-S2PATH medical GmbH · Audiometer1 recall0 reports
- Bio-logic OAE Ear ProbeNatus Medical Incorporated · Audiometer1 report
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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