# K974076: Sport/Audx Oae Test Instrument with Bio-Logic Ear Probe

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Logic Systems Corp.
- Decided: Jan 22, 1998 after 85 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
No predicates in its family tree.
6 later devices descend from it; 3 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)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K021801: Bio-Logic Abaer Cub with Integrated Oae & Abr Functions (2002), 4 descendants of its own
- K112247: A Baer with Abaer I/O Function (2012), 1 descendant of its own
- K111618: Audx Otoacoustic Emissions Measurement System with Audx I/O Function (2011), 1 descendant of its own
- K122496: Audx Pro Otoacoustic Emissions Measurement System (2012), 0 descendants of its own
- K090579: Smartscreener-PLUS2 (2009), 0 descendants of its own

## Indications for use
The Bio-logic OAE Ear Probe is used as an accessory to the Bio-logic SCOUT Sport and AuDX Otoacoustic Emissions Test Instruments. These instruments are identical to each other in purpose, and are indicated for use when it is necessary for a trained health care professional (for example, an Audiologist) to measure or determine cochlear function. This test consists of either measuring and recording transient (click-evoked) otoacoustic emissions (TEOQAE) or by measuring and recording distortion product otoacoustic emissions (DPOAE) utilizing continuous pure tones. The same Ear Probe is used with both instruments for both types of test. It can be used for patients of all ages, from newborn infants through adults, to and including geriatric patients. The otoacoustic emissions test is especially indicated for use in testing individuals for whom behavioral audiometric results are deemed unreliable, such as infants, young children, and cognitively impaired or uncooperative adults.

Source page: https://510kreport.com/device/K974076
Methodology: https://510kreport.com/methodology