510(k) · Cleared
ClearedCochlea-Scan / Cochlea-Scan Plus
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 Sep 15, 2006 as substantially equivalent to K013977 (Fischer-Zoth Audiologic Systems, Inc., 2002) after an 86-day review. Its family tree reaches back 4 generations to 1990. 5 later devices descend from it.
- Decided
- Sep 15, 2006
- Review
- 86 days
- Class
- Class II
- Product code
- EWO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K902540 (1990). 11 ancestors in all. 5 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK902540 Gsi 17 Screening AudiometerGrason-Stadler, Inc. · 1990
- 3 generations backK974237 Gsi 70 Audiopath ScreenerGrason-Stadler, Inc. · 1998
- 2 generations backK982642 Echo-ScreenFischer-Zoth Audiologic Systems, Inc. · 1998
- 1 generation backK013977 Echo-Screen T, TA, TD, Tda, TCFischer-Zoth Audiologic Systems, Inc. · 2002
- This deviceK061744 Cochlea-Scan / Cochlea-Scan PlusBio-Logic Systems Corp. · 2006
- Descendant · cites it directly · 4 of its ownK133012 SentieroPath Medical GmbH · 2014 · Recalled
- Descendant · 2 generations on · 1 of its ownK171038 Hearing Healthcare ProDb Diagnostic Systems, Inc. · 2017
- Descendant · 2 generations on · 0 of its ownK220139 QScreenPath Medical GmbH · 2022
- Descendant · 2 generations on · 0 of its ownK213345 Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero…Path Medical GmbH · 2022 · Recalled
- Descendant · 3 generations on · 0 of its ownK183201 Hearing Healthcare ProDb Diagnostic Systems, Inc. · 2019
Most influential descendants
Showing 5 of 5 · See all- K133012SentieroPath Medical GmbH · 2014 · cites it directly4descendants
- K171038Hearing Healthcare ProDb Diagnostic Systems, Inc. · 2017 · 2 generations on1descendant
- K220139QScreenPath Medical GmbH · 2022 · 2 generations on0descendants
- K213345Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONEPath Medical GmbH · 2022 · 2 generations on0descendants
- K183201Hearing Healthcare ProDb Diagnostic Systems, Inc. · 2019 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K902540 | Gsi 17 Screening Audiometer | Grason-Stadler, Inc. | 1990 | — |
| −3 | K974237 | Gsi 70 Audiopath Screener | Grason-Stadler, Inc. | 1998 | — |
| −2 | K982642 | Echo-Screen | Fischer-Zoth Audiologic Systems, Inc. | 1998 | — |
| −1 | K013977 | Echo-Screen T, TA, TD, Tda, TC | Fischer-Zoth Audiologic Systems, Inc. | 2002 | — |
| 0 (this device) | K061744 | Cochlea-Scan / Cochlea-Scan Plus | Bio-Logic Systems Corp. | 2006 | — |
| +1 | K133012 | Sentiero | Path Medical GmbH | 2014 | 4 |
| +2 | K171038 | Hearing Healthcare Pro | Db Diagnostic Systems, Inc. | 2017 | — |
| +2 | K220139 | QScreen | Path Medical GmbH | 2022 | — |
| +2 | K213345 | Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced… | Path Medical GmbH | 2022 | 4 |
| +3 | K183201 | Hearing Healthcare Pro | Db Diagnostic Systems, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 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? (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 |
|---|---|---|---|
| * | K013977 | Echo-Screen T, TA, TD, Tda, TCSummary page 1…ame - Audiometer, EWO Proprietary / Trade name: Cochlea-Scan / Cochlea-Scan Plus Predicate Device: Fischer-Zoth, model Echo-Screen: 510(k) K013977 Device description: Cochlea-Scan is a hand-held examination system based on Otoacoustic Emissions (OAE) technology. Identical tec… | 2002 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133012 | Sentiero | 2014 | 4 |
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 16 years and passes through 3 companies; a new generation was cleared every 4.3 years on median.
- 2 of the 11 ancestors have a recall of any class.
- Of its descendants, K133012 (Path Medical GmbH, 2014) has gone furthest, with 4 descendants of its own.
- 5 other devices also cite its predicate K013977.
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?
1. The Cochlea Scan is intended for use in automated objective hearing assessment using distortion product OAEs.
2. The Cochlea Scan is intended for use in diagnostic hearing evaluations and assistance in the diagnosis of possible hearing disorders by means of OAEs and/or pure tone audiometry. Hearing disorders include middle ear and cochlear hearing losses.
3. The results of the Cochlea Scan can be used to assist in the selection and/or (first-) fit of conventional hearing aids. It does not provide data for prescribing or fitting cochlear implants or middle ear implants.
4. The Cochlea Scan is intended for use in hearing screening using OAEs (with optional TEOAE module).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061744 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061744: Cochlea-Scan / Cochlea-Scan Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061744
Report an extraction error
Are you the manufacturer?
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