# K112247: A Baer with Abaer I/O Function

- Pathway: 510(k) (Traditional)
- Applicant: Natus Medical Incorporated
- Decided: Apr 2, 2012 after 242 days
- Product code: EWO (Audiometer)
- Device class: 2
- Regulation: 21 CFR 874.1050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K930328 (1993). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021801: Bio-Logic Abaer Cub with Integrated Oae & Abr Functions, Bio-Logic Systems Corp. (2002) Summary page 1.
- K964132: Modification to Otoacoustic Emissions (OAE0 Test Instrument, Bio-Logic Systems Corp. (1997) Summary page 1.
- K072033: Otodynamics Otoport, Otodynamics, Ltd. (2007) Summary page 1.

## Most influential descendants
- K122496: Audx Pro Otoacoustic Emissions Measurement System (2012), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K112247
Methodology: https://510kreport.com/methodology