510(k) · Cleared
ClearedhearOAE
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hearx SA (Pty), Ltd. · EWO Audiometer
Cleared on Oct 27, 2023 as substantially equivalent to K983350 (Otodynamics, Ltd., 1998) after a 150-day review. Its family tree reaches back 1 generation to 1998.
- Decided
- Oct 27, 2023
- Review
- 150 days
- Class
- Class II
- Product code
- EWO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K983350 (1998). No later device cites it as a predicate yet.
- Root · 1 generation backK983350 ILO292 DP Echoport Plus Oae SystemOtodynamics, Ltd. · 1998
- This deviceK231545 hearOAEHearx SA (Pty), Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K983350 | ILO292 DP Echoport Plus Oae System | Otodynamics, Ltd. | 1998 | — |
| 0 (this device) | K231545 | hearOAE | Hearx SA (Pty), Ltd. | 2023 | — |
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? (1)
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 |
|---|---|---|---|
| * | K983350 | ILO292 DP Echoport Plus Oae SystemSummary page 4…(21 CFR 874.1050) Regulation Class: Class II Product Code: EWO Assigned K-number: K231545 3. PREDICATE DEVICE Otodynamics ILO288 Echoport Plus OAE System (K983350) 4. DEVICE DESCRIPTION Per 21 CFR 874.1050, the hearOAE (otoacoustic emission device) is a portable, handheld, battery-op… | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K983350.
How does its category compare?
All EWO devicesEWO Audiometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
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?
hearOAE is intended to be used by hearing healthcare professionals in the audiologic evaluation and documentation of ear function and ear disorders using Transient Evoked Otoacoustic Emissions (TEOAEs) and Distortion Product Otoacoustic Emissions (DPOAEs). The target population for the hearOAE includes all ages.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231545 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231545: hearOAE.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231545
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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