510(k) · Cleared
ClearedOtoNova/OtoNova Pro
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Otodynamics · EWO Audiometer
Cleared on Jun 21, 2024 as substantially equivalent to K143395 (Otodynamics, Ltd., 2015) after a 178-day review. Its family tree reaches back 7 generations to 1990.
- Decided
- Jun 21, 2024
- Review
- 178 days
- Class
- Class II
- Product code
- EWO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K902540 (1990). 19 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK902540 Gsi 17 Screening AudiometerGrason-Stadler, Inc. · 1990
- 6 generations backK974237 Gsi 70 Audiopath ScreenerGrason-Stadler, Inc. · 1998
- 5 generations backK982642 Echo-ScreenFischer-Zoth Audiologic Systems, Inc. · 1998
- 4 generations backK013977 Echo-Screen T, TA, TD, Tda, TCFischer-Zoth Audiologic Systems, Inc. · 2002
- 3 generations backK122067 Type 1077 AccuscreenGn Otometrics · 2012
- 2 generations backK132957 Madsen Accuscreen Type 1077Gn Otometrics · 2014
- 1 generation backK143395 Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR…Otodynamics, Ltd. · 2015
- This deviceK234095 OtoNova/OtoNova ProOtodynamics · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K902540 | Gsi 17 Screening Audiometer | Grason-Stadler, Inc. | 1990 | — |
| −6 | K974237 | Gsi 70 Audiopath Screener | Grason-Stadler, Inc. | 1998 | — |
| −5 | K982642 | Echo-Screen | Fischer-Zoth Audiologic Systems, Inc. | 1998 | — |
| −4 | K013977 | Echo-Screen T, TA, TD, Tda, TC | Fischer-Zoth Audiologic Systems, Inc. | 2002 | — |
| −3 | K122067 | Type 1077 Accuscreen | Gn Otometrics | 2012 | — |
| −2 | K132957 | Madsen Accuscreen Type 1077 | Gn Otometrics | 2014 | — |
| −1 | K143395 | Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR… | Otodynamics, Ltd. | 2015 | — |
| 0 (this device) | K234095 | OtoNova/OtoNova Pro | Otodynamics | 2024 | — |
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 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2007 | 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 K240430 Otoport Proscore 8.8 · 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 |
|---|---|---|---|
| * | K143395 | Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR Screener-Otocheck…Summary page 4…t Codes: EWO & GWJ PREDICATE DEVICE The legally marketed device to which equivalence is being claimed [807.92(a)(3)] is the Otoport/ Otocheck OAE+ABR ™, K143395. This predicate has not been the subject of any design-related recalls. DEVICE DESCRIPTION OtoNova is a compact, portable batt… | 2015 |
| † | K962995 | ILO88. Otodynamic Analyser, Kit System for PC | 1997 |
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 34 years and passes through 5 companies; a new generation was cleared every 3.6 years on median.
- 2 of the 19 ancestors have a recall of any class.
- 1 other device also cites its predicate K143395.
How does its category compare?
All EWO devicesEWO Audiometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
This Otonova Pro device is indicated for use when there is a requirement to screen for hearing disorders by objective and non-invasive means. ABR, TEOAE and DPOAE screening test results are automatically interpreted and a clear ‘Pass’ or ‘Refer’ result is presented to the user. Use of the device is indicated when the patient is unable to give reliable voluntary responses to sound, especially with infants. Use of the device facilitates the early detection…
Read the full statement (192 words)
This Otonova Pro device is indicated for use when there is a requirement to screen for hearing disorders by objective and non-invasive means. ABR, TEOAE and DPOAE screening test results are automatically interpreted and a clear ‘Pass’ or ‘Refer’ result is presented to the user. Use of the device is indicated when the patient is unable to give reliable voluntary responses to sound, especially with infants.
Use of the device facilitates the early detection of hearing loss and its characterization. Where the individual to be screened is healthy with no medical conditions related to the ear, as in the case of well-baby hearing screening, the user can be a trained screener. In all other cases the user should be an audiologist or medical professional.
The TEOAE and DPOAE analytical functions of the device are indicated when objective non-invasive clinical investigations require the characterization and monitoring of the functional status of the peripheral auditory function. For this purpose, the device is intended to be used by audiologists or other professionals skilled in audiology.
These TEOAE and DPOAE tests are applicable to populations of any age to obtain objective evidence of peripheral auditory function.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K234095 · printed Nov 4, 2026
Cite this page
510(k) Report. “K234095: OtoNova/OtoNova Pro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K234095
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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