510(k) · Cleared
ClearedSmarttroae
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intelligent Hearing Systems · EWO Audiometer
Cleared on Jan 8, 2003 as substantially equivalent to K962995 (Otodynamics, Ltd., 1997) and 1 other predicate after a 49-day review. Its family tree reaches back 1 generation to 1989. 2 later devices descend from it.
- Decided
- Jan 8, 2003
- Review
- 49 days
- Class
- Class II
- Product code
- EWO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K890124 (1989). 2 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK890124 ILO88 Otodynamic Analyzer Screening AudiometerGrason-Stadler, Inc. · 1989
- This deviceK023859 SmarttroaeIntelligent Hearing Systems · 2003
- Descendant · cites it directly · 1 of its ownK061443 Smart Usblite, Model M011120Intelligent Hearing Systems · 2006
- Descendant · 2 generations on · 0 of its ownK193033 GSI Audera ProGrason Stadler · 2020
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K890124 | ILO88 Otodynamic Analyzer Screening Audiometer | Grason-Stadler, Inc. | 1989 | — |
| 0 (this device) | K023859 | Smarttroae | Intelligent Hearing Systems | 2003 | — |
| +1 | K061443 | Smart Usblite, Model M011120 | Intelligent Hearing Systems | 2006 | — |
| +2 | K193033 | GSI Audera Pro | Grason Stadler | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2020 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in EWO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new EWO device
- #1 K234095 OtoNova/OtoNova Proscore 9.3 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K962995 | ILO88. Otodynamic Analyser, Kit System for PCSummary page 1…ic Emissions Test Instrument Classification Name: Audiometer (per CFR 874.1050) Predicate Device: Otodynamics L O 8 8 (K962995) Device Description: SmartTrOAE is an otoacoustic einissions testing device that is… | 1997 |
| * | K890124 | ILO88 Otodynamic Analyzer Screening AudiometerSummary page 2…Based on Assessment of Performance Data: The SmartTrOAE is substantially equivalent to the E 0 8 8 device marketed by Otodynamics Ltd. with FDA 5 1O(k) clearance number K890124. Predicate Device Device Under Current… | 1989 |
| † | K930553 | Cub Dis Otoacoustic Emissions Test Instrument | 1993 |
| † | K011114 | Etymotic Research ER-10D Oae Probe | 2001 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061443 | Smart Usblite, Model M011120 | 2006 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All EWO devicesEWO Audiometer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EWO
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · EWO
173in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EWO
4in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EWO
13in 2025
MAUDE reports naming product code EWO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 5 | 69 | 0 | 1 |
| 2008 | 1 | — | 1 | 1 |
| 2009 | 2 | — | 0 | 1 |
| 2010 | 2 | — | 0 | 4 |
| 2011 | 3 | 151 | 0 | 2 |
| 2012 | 4 | 137 | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 4 | 173 | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 7 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 1 | — | 0 | 6 |
| 2023 | 1 | — | 4 | 3 |
| 2024 | 2 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 13 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023859 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023859: Smarttroae.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023859
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026