# K961447: Scout Sport - a Modification to (Formerly Emav) Otoacoustic Emissions (Oae) Test Instrument

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Logic Systems Corp.
- Decided: May 29, 1996 after 43 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 K944735 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944735: Bio-Logic Emav Emission Averaging Otoacoustic Test, Bio-Logic Systems Corp. (1994) Summary page 1.

## Indications for use
The intended use of the Scout Sport Otoacoustic Emissions Test Instrument is to measure or determine cochlear function either by measuring and recording transient (click evoked) otoacoustic emissions or by measuring and recording distortion product otoacoustic emissions utilizing continuous pure tones. This intended use is identical to that of the predicate device.

Source page: https://510kreport.com/device/K961447
Methodology: https://510kreport.com/methodology