510(k) · Cleared
ClearedA Baer with Abaer I/O Function
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Natus Medical Incorporated · EWO Audiometer
Cleared on Apr 2, 2012 as substantially equivalent to K021801 (Bio-Logic Systems Corp., 2002) and 2 other predicates after a 242-day review. Its family tree reaches back 5 generations to 1993. 1 later device descends from it.
- Decided
- Apr 2, 2012
- Review
- 242 days
- Class
- Class II
- Product code
- EWO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K930328 (1993). 11 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK930328 Navigator & Traveler Evoked Postential ProductBio-Logic Systems Corp. · 1993
- 4 generations backK992807 Bio-Logic Evoked Potential for Abaer IBio-Logic Systems Corp. · 1999
- 3 generations backK994149 Modification to Bio-Logic Evoked Potential for Abaer/ Navigator Pro.Bio-Logic Systems Corp. · 1999
- 2 generations backK021215 Bio-Logic Abaer CubBio-Logic Systems Corp. · 2002
- 1 generation backK021801 Bio-Logic Abaer Cub with Integrated Oae & Abr FunctionsBio-Logic Systems Corp. · 2002
- This deviceK112247 A Baer with Abaer I/O FunctionNatus Medical Incorporated · 2012
- Descendant · cites it directly · 0 of its ownK122496 Audx Pro Otoacoustic Emissions Measurement SystemBio-Logic Systems Corp. · 2012
Most influential descendants
Showing 1 of 1 · See all- K122496Audx Pro 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 |
|---|---|---|---|---|---|
| −5 | K930328 | Navigator & Traveler Evoked Postential Product | Bio-Logic Systems Corp. | 1993 | — |
| −4 | K992807 | Bio-Logic Evoked Potential for Abaer I | Bio-Logic Systems Corp. | 1999 | — |
| −3 | K994149 | Modification to Bio-Logic Evoked Potential for Abaer/ Navigator Pro. | Bio-Logic Systems Corp. | 1999 | — |
| −2 | K021215 | Bio-Logic Abaer Cub | Bio-Logic Systems Corp. | 2002 | — |
| −1 | K021801 | Bio-Logic Abaer Cub with Integrated Oae & Abr Functions | Bio-Logic Systems Corp. | 2002 | — |
| 0 (this device) | K112247 | A Baer with Abaer I/O Function | Natus Medical Incorporated | 2012 | — |
| +1 | K122496 | Audx Pro Otoacoustic Emissions Measurement System | Bio-Logic Systems Corp. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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? (3)
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 |
|---|---|---|---|
| * | K021801 | Bio-Logic Abaer Cub with Integrated Oae & Abr FunctionsSummary page 1…, Product Code: EWO Evoked response auditory stimulator 21 CFR 882.1900 Product Code: GWJ Predicate Devices: K021801 ABaer Cub with Automated OAE and ABIR K9641 32 Bio-logic Scout and Scout Sport Otoacoustic… | 2002 |
| * | K964132 | Modification to Otoacoustic Emissions (OAE0 Test InstrumentSummary page 1…timulator 21 CFR 882.1900 Product Code: GWJ Predicate Devices: K021801 ABaer Cub with Automated OAE and ABIR K9641 32 Bio-logic Scout and Scout Sport Otoacoustic Emissions (OAE) Test Instruments with TEOAE and DPOAE… | 1997 |
| * | K072033 | Otodynamics OtoportSummary page 1…E Software, incorporating the modifications of Automated Input!/ Output Software Functions K072033 Otodynamics Otoport Device Description: The AlBaer I/O Function is a Windows@ based software app… | 2007 |
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 |
|---|---|---|---|
| K122496 | Audx Pro Otoacoustic Emissions Measurement System | 2012 | 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?
- The line of descent spans 19 years and passes through 2 companies; a new generation was cleared every 2.4 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K122496 (Bio-Logic Systems Corp., 2012) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K021801.
How does its category compare?
All EWO devicesEWO Audiometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Hearing Screening System (HSS) ABaer performs an automated brainstemn auditory evoked response (A~aer) screening and/or an automated otoacoustic emissions (AOAE) screening. The automated auditory brainstem response test (AABR) involves placement of three recording electrodes on an infant's head. The electrodes record the electrical activity generated by the auditory nervous system that result from presentation of a click stimulus into the ear. The…
Read the full statement (421 words)
The Hearing Screening System (HSS) ABaer performs an automated brainstemn auditory evoked response (A~aer) screening and/or an automated otoacoustic emissions (AOAE) screening. The automated auditory brainstem response test (AABR) involves placement of three recording electrodes on an infant's head. The electrodes record the electrical activity generated by the auditory nervous system that result from presentation of a click stimulus into the ear. The automated otoacoustic emissions (AOAE) screening involves producing controlled acoustic signals in the ear canal and measuring the resulting evoked otoacoustic emissions that are generated by the inner ear as a result of normal hearing processes. The ABaer device performs both distortion product otoacoustic emissions (DPOAE) tests and transient evoked otoacoustic emissions (TEOAE) tests.
The ABaer 1/O is a software option to be used in conjunction with the ABaer System. The standard DPOAE test measures otoacoustic response to a series of frequency-pairs of tones, varying the frequency while keeping the level or intensity of the stimulus tones at a constant level. The ABaer 1/O software option enables the ABaer device user to perform DPOAE testing at different stimulus intensities in order to obtain the 'DPOAE Input / Output (1/O) function' for user defined test frequencies, frequency ratios and intensity levels. The graphical representation of the test results in the form of stimulus level presented versus measured DPOAE level provides an effective way for the user to view and evaluate stimulus level-sensitive information about DPOAE responses. DPOAE threshold is the lowest stimulus intensity level which produces 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 and auditory threshold. Whereas auditory threshold measures assess the integrity of the entire auditory system from outer ear to cortex, DPOAE threshold measures, which the user can interpret from the DPOAE 1/O functions, are limited to assessment of outer hair cell function in the cochlea only,
The 'ABaer System with ABaer 1/O Function' is indicated for use when it is necessary for a trained health care professional to measure or determine cochlear function. The device can be used for patients of all ages, from newborn infants through adults, to include geriatric patients. the otoacoustic emissions test is especially indicated for use in testing individuals for whom behavioral results are deemed unreliable, such as infants, young children, and cognitively impaired adults.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112247 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112247: A Baer with Abaer I/O Function.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112247
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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