510(k) · Cleared
ClearedEro-Scan Otoacoustic Emissions Test Inst. (ER34)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Etymotic Research · EWO Audiometer
Cleared on Mar 23, 1998 as substantially equivalent to K930553 (Etymotic Research, 1993) after a 40-day review. Its family tree reaches back 1 generation to 1993. 2 later devices descend from it.
- Decided
- Mar 23, 1998
- Review
- 40 days
- Class
- Class II
- Product code
- EWO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K930553 (1993). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK930553 Cub Dis Otoacoustic Emissions Test InstrumentEtymotic Research · 1993
- This deviceK980533 Ero-Scan Otoacoustic Emissions Test Inst. (ER34)Etymotic Research · 1998
- Descendant · cites it directly · 0 of its ownK112733 ER35 Ero-Scan Pro Hearing Test SystemEtymotic Research, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK070880 ER35 Ero-Scan Pro Hearing Test SystemEtymotic Research, Inc. · 2007
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 | K930553 | Cub Dis Otoacoustic Emissions Test Instrument | Etymotic Research | 1993 | — |
| 0 (this device) | K980533 | Ero-Scan Otoacoustic Emissions Test Inst. (ER34) | Etymotic Research | 1998 | — |
| +1 | K112733 | ER35 Ero-Scan Pro Hearing Test System | Etymotic Research, Inc. | 2011 | — |
| +1 | K070880 | ER35 Ero-Scan Pro Hearing Test System | Etymotic Research, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2011 | 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 9.4 · 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? (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 |
|---|---|---|---|
| * | K930553 | Cub Dis Otoacoustic Emissions Test InstrumentSummary page 1…ment of otoacoustic emissions (OAEs). This device is substantially equivalent to the marketed Etymotic Research Cub’Dis Otoacoustic Emissions Test Instrument, 510(k) No. K930553, September 29, 1993. Substantial equivalence of the EROeSCAN instrument to Etymotic Research Cub®Dis predicate device referenced… | 1993 |
What descends from it? (2)
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?
- Its one ancestor has no recall.
- Of its descendants, K112733 (Etymotic Research, Inc., 2011) has gone furthest, with 0 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 EROeSCAN Otoacoustic Emissions Test Instrument is a hand-held auditory test instrument designed to evoke or stimulate the generation of distortion product otoacoustic emissions (DPOAEs), utilizing pure-tone stimulus presentation, for the purpose of determining the presence of cochlear function in adults, children and infants. Otoacoustic emissions are low-level audio-frequency sounds that are produced by the cochlea as part of the normal-hearing…
Read the full statement (126 words)
The EROeSCAN Otoacoustic Emissions Test Instrument is a hand-held auditory test instrument designed to evoke or stimulate the generation of distortion product otoacoustic emissions (DPOAEs), utilizing pure-tone stimulus presentation, for the purpose of determining the presence of cochlear function in adults, children and infants.
Otoacoustic emissions are low-level audio-frequency sounds that are produced by the cochlea as part of the normal-hearing process. Available evidence suggests that otoacoustic emissions are generated by the cochlea’s outer hair cells and that the presence of OAEs is an indication that the outer hair cells are viable. Clinical evidence indicates that these emissions normally occur with normal hearing or, at most, mild hearing loss (usually 30-40 dB HL). The majority of hearing-impaired individuals will be identified by a simple OAE test.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K980533 · printed Nov 5, 2026
Cite this page
510(k) Report. “K980533: Ero-Scan Otoacoustic Emissions Test Inst. (ER34).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K980533
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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