510(k) · Cleared
ClearedER36 Series OAE 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 Mar 26, 2015 as substantially equivalent to K010165 (Etymotic Research, 2001) after a 29-day review. Its family tree reaches back 1 generation to 2001. 1 later device descends from it.
- Decided
- Mar 26, 2015
- Review
- 29 days
- Class
- Class II
- Product code
- EWO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K010165 (2001). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K180287GSI CortiGrason-Stadler, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K010165 | Ero Scan Oae Test System | Etymotic Research | 2001 | — |
| 0 (this device) | K150491 | ER36 Series OAE Test System | Etymotic Research, Inc. | 2015 | — |
| +1 | K180287 | GSI Corti | Grason-Stadler, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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? (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 |
|---|---|---|---|
| * | K010165 | Ero Scan Oae Test SystemSummary page 4…on Name: Class II Audiometer Device Classification: Class II, 21 CFR 874.1050 III. PREDICATE DEVICE Predicate Devices: ERO•SCANTM OAE Test System (K010165) Etymotic Research, Inc. Class II, 21 CFR 874.1050 Purpose of the Specia… | 2001 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K180287 | GSI Corti | 2018 | 0 |
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. 2015, 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 ER36 Series OAE Test System is indicated for testing of cochlear function in infants, children, and adults by measuring otoacoustic emissions (OAEs). The OAEs are generated by a series of clicks or tones that are directed into the ear canal. 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…
Read the full statement (125 words)
The ER36 Series OAE Test System is indicated for testing of cochlear function in infants, children, and adults by measuring otoacoustic emissions (OAEs). The OAEs are generated by a series of clicks or tones that are directed into the ear canal. 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 OAE's 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 30-40dB HL). The majority of hearing-impaired individuals will be identified by a simple OAE test.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150491 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150491: ER36 Series OAE 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/K150491
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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