510(k) · Cleared
ClearedER35 Ero-Scan Pro Hearing Test System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Etymotic Research, Inc. · EWO Audiometer
Cleared on Dec 16, 2011 as substantially equivalent to K980533 (Etymotic Research, 1998) and 3 other predicates after an 87-day review. Its family tree reaches back 2 generations to 1993.
- Decided
- Dec 16, 2011
- Review
- 87 days
- Class
- Class II
- Product code
- EWO
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K930553 (1993). 5 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K930553 | Cub Dis Otoacoustic Emissions Test Instrument | Etymotic Research | 1993 | — |
| −1 | K980533 | Ero-Scan Otoacoustic Emissions Test Inst. (ER34) | Etymotic Research | 1998 | — |
| 0 (this device) | K112733 | ER35 Ero-Scan Pro Hearing Test System | Etymotic Research, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
| 2001 | 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? (4)
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 |
|---|---|---|---|
| * | K980533 | Ero-Scan Otoacoustic Emissions Test Inst. (ER34)Summary page 1…Class 11, 5 10O(k) Exempt, 21 CER §874.1050 Class 11, 21 CFR §874.1090 Predicate Devices: ERO*SCAN Otoacoustic Test Instrument (K980533; K010165) Etymotic Research, Inc. GS 12000 (Tym… | 1998 |
| * | K010165 | Ero Scan Oae Test SystemSummary page 1…CER §874.1050 Class 11, 21 CFR §874.1090 Predicate Devices: ERO*SCAN Otoacoustic Test Instrument (K980533; K010165) Etymotic Research, Inc. GS 12000 (TympStar TM) Middle Ear Analyzer (K0000… | 2001 |
| * | K000097 | Gsi 2000 Middle Ear AnalyzerSummary page 1…(K980533; K010165) Etymotic Research, Inc. GS 12000 (TympStar TM) Middle Ear Analyzer (K000097) VIASYS Healthcare (formerly Grason-Stadler Inc.) Interacoustics AT235H Im… | 2000 |
| * | K994254 | Interacoustics AT235 Impedance AudiometerSummary page 1…ar Analyzer (K000097) VIASYS Healthcare (formerly Grason-Stadler Inc.) Interacoustics AT235H Impedance Audiometer (K994254) Interacoustics A/S Device Description: The ER35 is a microprocessor-controlled instrument… | 2000 |
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?
- The line of descent spans 18 years and passes through 2 companies; a new generation was cleared every 13.7 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K980533.
How does its category compare?
All EWO devicesEWO Audiometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
The ER35 ERO-SCAN Pro Hearing Test System is indicated for testing of cochlear and middle ear function in infants, children, and adults by measuring otoacouIStic emnissions (OAEs). tympanomretry. and acoustic reflex.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112733 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112733: ER35 Ero-Scan Pro Hearing Test System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112733
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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