510(k) · Cleared
ClearedSport/Audx Oae Test Instrument with Bio-Logic Ear Probe
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 Jan 22, 1998 after an 85-day review. The FDA summary names no predicate by number. 6 later devices descend from it.
- Decided
- Jan 22, 1998
- Review
- 85 days
- Class
- Class II
- Product code
- EWO
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 3 citing it directly.
- This deviceK974076 Sport/Audx Oae Test Instrument with Bio-Logic Ear ProbeBio-Logic Systems Corp. · 1998
- Descendant · cites it directly · 4 of its ownK021801 Bio-Logic Abaer Cub with Integrated Oae & Abr FunctionsBio-Logic Systems Corp. · 2002
- Descendant · 2 generations on · 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 · 2 generations on · 0 of its ownK090579 Smartscreener-PLUS2Intelligent Hearing Systems · 2009
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K021801Bio-Logic Abaer Cub with Integrated Oae & Abr FunctionsBio-Logic Systems Corp. · 2002 · cites it directly4descendants
- K112247A Baer with Abaer I/O FunctionNatus Medical Incorporated · 2012 · 2 generations on1descendant
- 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
- K090579Smartscreener-PLUS2Intelligent Hearing Systems · 2009 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K974076 | Sport/Audx Oae Test Instrument with Bio-Logic Ear Probe | Bio-Logic Systems Corp. | 1998 | — |
| +1 | K021801 | Bio-Logic Abaer Cub with Integrated Oae & Abr Functions | Bio-Logic Systems Corp. | 2002 | — |
| +2 | 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 | — |
| +2 | K090579 | Smartscreener-PLUS2 | Intelligent Hearing Systems | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 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?
The FDA summary names no predicate by number.
What descends from it? (6)
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?
- Of its descendants, K021801 (Bio-Logic Systems Corp., 2002) has gone furthest, with 4 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 Bio-logic OAE Ear Probe is used as an accessory to the Bio-logic SCOUT Sport and AuDX Otoacoustic Emissions Test Instruments. These instruments are identical to each other in purpose, and are indicated for use when it is necessary for a trained health care professional (for example, an Audiologist) to measure or determine cochlear function. This test consists of either measuring and recording transient (click-evoked) otoacoustic emissions (TEOQAE) or…
Read the full statement (146 words)
The Bio-logic OAE Ear Probe is used as an accessory to the Bio-logic SCOUT Sport and AuDX Otoacoustic Emissions Test Instruments. These instruments are identical to each other in purpose, and are indicated for use when it is necessary for a trained health care professional (for example, an Audiologist) to measure or determine cochlear function. This test consists of either measuring and recording transient (click-evoked) otoacoustic emissions (TEOQAE) or by measuring and recording distortion product otoacoustic emissions (DPOAE) utilizing continuous pure tones. The same Ear Probe is used with both instruments for both types of test.
It can be used for patients of all ages, from newborn infants through adults, to and including geriatric patients. The otoacoustic emissions test is especially indicated for use in testing individuals for whom behavioral audiometric results are deemed unreliable, such as infants, young children, and cognitively impaired or uncooperative adults.
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/K974076 · printed Nov 4, 2026
Cite this page
510(k) Report. “K974076: Sport/Audx Oae Test Instrument with Bio-Logic Ear Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K974076
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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