Bio-logic OAE Ear ProbeRecalls & reported problems

Natus Medical Incorporated · OAE Ear Probe Assembly · Class 2

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 00382830000543), received between Sep 15, 2023 and Sep 15, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Data 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

Data Problem1
Unable to Obtain Readings1

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.

MalfunctionSep 15, 2023Unable to Obtain Readings; Data Problem; Unable to Obtain Readings; Data Problem
THE AFFECTED PART WAS NOT A ALGO 5 SYSTEM. IT WAS CONFIRMED THAT THE AFFECTED PART WAS PART 580-ABBOX1002 ABAER COLLECTION WITH DP. SEVERAL INFANTS WERE NOT ABLE TO BE SCREENED BEFORE DISCHARGE AS REQUIRED. REFERRALS MADE FOR OUTPATIENT TESTING. BIOMEDICAL STAFF TROUBLESHOOTING AND WORKING WITH COMPANY TO GET REPAIRED. PROCEDURE CARRIED OUT AT THE TIME WAS NEWBORN HEARING SCREENING AS REQUIRED BEFORE DISCHARGE. CUSTOMER STATES PROBLEM WAS DEVICE MALFUNCTION - THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17753859 ↗

Device details

UDI-DI	`00382830000543`
Brand	Bio-logic
Model	OAE Ear Probe
Catalog no.	580-PROAE3, 29402
Company	Natus Medical Incorporated
Product code	EWO · Audiometer
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	—
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	Not in Commercial Distribution
Record updated	Oct 9, 2023

Device type (GMDN): Evoked-potential audiometer

An electroacoustic instrument designed to evaluate the activity of the auditory pathway of the brain in response to an acoustic signal [auditory brainstem response (ABR)] it provides at the ear (e.g., clicks delivered through an earphone), without need of patient cooperation. The signal, detected via the device's scalp electrodes and possibly a reference electrode on the ear lobe, is measured using computer averaging and signal processing techniques. This device is typically used to assess the function of the auditory pathways and to differentiate coma due to metabolic factors from structural damage.

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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 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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