# K024205: Audioscreener Oae+Abr

- Pathway: 510(k) (Traditional)
- Applicant: Everest Biomedical Instruments Co.
- Decided: Mar 7, 2003 after 77 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: 1 generation back to K001058 (2000). 1 ancestor in all.
5 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001058: Audioscreener Oae + Abr, Kedly, Inc. (2000)

## Most influential descendants
- K143395: Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR Screener-Otocheck OAE+ABR, Otocheck OAE+ABR LE, Otocheck ABR Screener-Otodynamics ABR Upgrade Kit (2015), 2 descendants of its own
- K031713: Audiometer, Otoacoustic Emission, Auditory Branstem Response Access (2003), 1 descendant of its own
- K234095: OtoNova/OtoNova Pro (2024), 0 descendants of its own
- K240430: Otoport Pro (2024), 0 descendants of its own
- K073384: Smart Coupler, Model M015401 (2008), 0 descendants of its own

## Indications for use
The Audioscreener OAE+ABR may be used for patients of all ages, from newborn infants through adults. The Distortion Product Otoacoustic Emissions, Transient Evoked Otoacoustic Emissions, and Auditory Brainstem Response tests are indicated for use in screening individuals for hearing loss for whom behavioral audiometric responses are deemed to be unreliable, such as in infants, young children, and uncooperative or cognitively impaired adults.

Source page: https://510kreport.com/device/K024205
Methodology: https://510kreport.com/methodology