510(k) · Cleared
ClearedDPOAE20 , Eclipse
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Interacoustics A/S, Assens · EWO Audiometer
Cleared on May 30, 2006 after a 90-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 7 later devices descend from it.
- Decided
- May 30, 2006
- Review
- 90 days
- Class
- Class II
- Product code
- EWO
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 2 citing it directly.
- This deviceK060539 DPOAE20 , EclipseInteracoustics A/S, Assens · 2006
- Descendant · cites it directly · 5 of its ownK103760 TITANInteracoustics A/S · 2011
- Descendant · 2 generations on · 4 of its ownK130795 TITANInteracoustics A/S · 2013
- Descendant · 2 generations on · 1 of its ownK171506 EasyscreenMaico Diagnostics GmbH · 2017
- Descendant · 2 generations on · 0 of its ownK191372 LyraInteracoustics A/S · 2019
- Descendant · 3 generations on · 0 of its ownK173567 SeraInteracoustics A/S · 2018
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K103760TITANInteracoustics A/S · 2011 · cites it directly5descendants
- K130795TITANInteracoustics A/S · 2013 · 2 generations on4descendants
- K171506EasyscreenMaico Diagnostics GmbH · 2017 · 2 generations on1descendant
- K191372LyraInteracoustics A/S · 2019 · 2 generations on0descendants
- K173567SeraInteracoustics A/S · 2018 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K060539 | DPOAE20 , Eclipse | Interacoustics A/S, Assens | 2006 | — |
| +1 | K103760 | TITAN | Interacoustics A/S | 2011 | — |
| +2 | K130795 | TITAN | Interacoustics A/S | 2013 | — |
| +2 | K171506 | Easyscreen | Maico Diagnostics GmbH | 2017 | — |
| +2 | K191372 | Lyra | Interacoustics A/S | 2019 | — |
| +3 | K173567 | Sera | Interacoustics A/S | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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 9.4 · 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (7)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K103760 (Interacoustics A/S, 2011) has gone furthest, with 5 descendants of its own.
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 Interacoustics DPOAE20 system is for use in the audiologic evaluation and documentation of ear disorders using Distortion Product Otoacoustic Emission tone stimuli. The presence of Otoacoustic emissions suggests normal outer hair cell function within cochlea, which in turn suggests normal hearing. OAEs are recorded using an OAE probe which is placed in the ear canal. The OAE response from the ear.is recorded and processed by the Eclipse and the…
Read the full statement (111 words)
The Interacoustics DPOAE20 system is for use in the audiologic evaluation and documentation of ear disorders using Distortion Product Otoacoustic Emission tone stimuli.
The presence of Otoacoustic emissions suggests normal outer hair cell function within cochlea, which in turn suggests normal hearing. OAEs are recorded using an OAE probe which is placed in the ear canal. The OAE response from the ear.is recorded and processed by the Eclipse and the DPOAE2O software and then displayed on the computer screen for evaluation.
This is of.particular interest to Ear, Nose, and Throat doctors, Neurology specialists, Audiologist and other health- professionals concerned with measuring auditory functions. The patient group includes all ages and sexes.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K060539 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060539: DPOAE20 , Eclipse.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060539
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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