# K023859: Smarttroae

- Pathway: 510(k) (Traditional)
- Applicant: Intelligent Hearing Systems
- Decided: Jan 8, 2003 after 49 days
- Product code: EWO (Audiometer)
- Device class: 2
- Regulation: 21 CFR 874.1050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K890124 (1989). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962995: ILO88. Otodynamic Analyser, Kit System for PC, Otodynamics, Ltd. (1997) Summary page 1.
- K890124: ILO88 Otodynamic Analyzer Screening Audiometer, Grason-Stadler, Inc. (1989) Summary page 2.

## Most influential descendants
- K061443: Smart Usblite, Model M011120 (2006), 1 descendant of its own
- K193033: GSI Audera Pro (2020), 0 descendants of its own

## Indications for use
The intended use of the SmartTrOAE device is to measure otoacoustic emissions, which allow the operator to get information on cochlear hnction without requiring a subjective response from the person being tested with the device. It is intended to be used by trained personnel in a hospital, nursery, clinic, audiologist’s office or other appropriate setting. The anatomical site of contact is the patient’s outer ear canal(s) with the contact object being a probe that is capable of measuring and delivering sound.

Source page: https://510kreport.com/device/K023859
Methodology: https://510kreport.com/methodology