510(k) · Cleared
ClearedModification to Otoacoustic Emissions (OAE0 Test Instrument
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Logic Systems Corp. · EWO Audiometer
Cleared on May 13, 1997 as substantially equivalent to K944735 (Bio-Logic Systems Corp., 1994) after a 210-day review. Its family tree reaches back 1 generation to 1994. 4 later devices descend from it.
- Decided
- May 13, 1997
- Review
- 210 days
- Class
- Class II
- Product code
- EWO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K944735 (1994). 4 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK944735 Bio-Logic Emav Emission Averaging Otoacoustic TestBio-Logic Systems Corp. · 1994
- This deviceK964132 Modification to Otoacoustic Emissions (OAE0 Test InstrumentBio-Logic Systems Corp. · 1997
- Descendant · cites it directly · 1 of its ownK112247 A Baer with Abaer I/O FunctionNatus Medical Incorporated · 2012
- Descendant · cites it directly · 1 of its ownK111618 Audx Otoacoustic Emissions Measurement System with Audx I/O FunctionNatus Medical Incorporated · 2011
- Descendant · 2 generations on · 0 of its ownK122496 Audx Pro Otoacoustic Emissions Measurement SystemBio-Logic Systems Corp. · 2012
- Descendant · cites it directly · 0 of its ownK121512 Scout Sport Otoacoustic Emissions Measurement SystemBio-Logic Systems Corp. · 2012
Most influential descendants
Showing 4 of 4 · See all- K112247A Baer with Abaer I/O FunctionNatus Medical Incorporated · 2012 · cites it directly1descendant
- K111618Audx Otoacoustic Emissions Measurement System with Audx I/O FunctionNatus Medical Incorporated · 2011 · cites it directly1descendant
- K122496Audx Pro Otoacoustic Emissions Measurement SystemBio-Logic Systems Corp. · 2012 · 2 generations on0descendants
- K121512Scout Sport Otoacoustic Emissions Measurement SystemBio-Logic Systems Corp. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K944735 | Bio-Logic Emav Emission Averaging Otoacoustic Test | Bio-Logic Systems Corp. | 1994 | — |
| 0 (this device) | K964132 | Modification to Otoacoustic Emissions (OAE0 Test Instrument | Bio-Logic Systems Corp. | 1997 | — |
| +1 | K112247 | A Baer with Abaer I/O Function | Natus Medical Incorporated | 2012 | — |
| +1 | K111618 | Audx Otoacoustic Emissions Measurement System with Audx I/O Function | Natus Medical Incorporated | 2011 | — |
| +2 | K122496 | Audx Pro Otoacoustic Emissions Measurement System | Bio-Logic Systems Corp. | 2012 | — |
| +1 | K121512 | Scout Sport Otoacoustic Emissions Measurement System | Bio-Logic Systems Corp. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 3 | 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 |
|---|---|---|---|
| * | K944735 | Bio-Logic Emav Emission Averaging Otoacoustic TestSummary page 1…dition to the Scout Otoacoustic Emissions (OAE) Test Instrument. Otoacoustic Emissions Test Instrument Audiometer (per CFR 874.1050) . Bio-logic Scout OAE Instrument (K944735) Page 7 REVISED STATEMENT OF INTENDED USE FOR 510(k) #K964132 INTENDED USE: The intended use of the current Sco… | 1994 |
What descends from it? (4)
3 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?
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 intended use of the current Scout Otoacoustic Emissions Test Instrument is to measure or determine cochlear function either by measuring and recording transient (click evoked) otoacoustic emissions or by measuring and recording distortion product otoacoustic emissions utilizing continuous pure tones. The intended use of this new software feature is essentially the same as that of the predicate device. It provides for an additional test methodology…
Read the full statement (286 words)
The intended use of the current Scout Otoacoustic Emissions Test Instrument is to measure or determine cochlear function either by measuring and recording transient (click evoked) otoacoustic emissions or by measuring and recording distortion product otoacoustic emissions utilizing continuous pure tones. The intended use of this new software feature is essentially the same as that of the predicate device. It provides for an additional test methodology which measures DPOAE threshold instead of the more-routine DPOAE amplitude test. The threshold test (also called the Input/Output (I/O) function) involves varying the stimulus intensity levels while keeping the frequencies constant. Both test methods can be effectively used to differentiate normal and hearing-impaired subjects, but the amplitude test is usually preferred because it usually requires a shorter testing time. However, in cases where the amplitude test results in a DP-gram with a low DP response (close to the noise floor) at specific frequencies, the I/O function test can be used to determine if there is an improved response at other stimulus frequencies. Therefore, the I/O function test offers the potential to improve the identification of patients with normal hearing.
DPOAE threshold is the lowest stimulus intensity level which produces a DPOAE response amplitude that is distinguishable from the level of system distortion and from the noise floor. DPOAE threshold is expressed in much of the published literature as the lowest intensity of the F2 stimulus that generates a clear DPOAE response. DPOAE threshold does not equate to and should not be confused with audiometric or auditory threshold. Whereas auditory threshold measures assess the integrity of the entire auditory system from outer ear to cortex, DPOAE threshold measures are limited to assessment of outer hair cell function in the cochlea only.
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/K964132 · printed Nov 4, 2026
Cite this page
510(k) Report. “K964132: Modification to Otoacoustic Emissions (OAE0 Test Instrument.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964132
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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