# K121512: Scout Sport Otoacoustic Emissions Measurement System

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Logic Systems Corp.
- Decided: Jul 26, 2012 after 66 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: 2 generations back to K944735 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964132: Modification to Otoacoustic Emissions (OAE0 Test Instrument, Bio-Logic Systems Corp. (1997) Summary page 1.

## Cited in the summary but kept off the family tree
- K011224: Hdi 5000 Ultrasound System with Assisted Border Detection (Abd), Xres Imaging, and Panoramic Measurement Capability, Advanced Technology Laboratories, Inc. (2001). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The Scout Sport Otoacoustic Emissions Measurement System delivers controlled acoustic signals in the ear canal and measures the resulting evoked otoacoustic emissions (OA~s) that are generated by the outer hair cells of the inner ear. The Scout Sport device performs transient evoked otoacaustic emissions (TEOAE), distortion product otoacoustic emissions (DPOAE), and DPOAE Input/Output (I/O) tests. Scout Sport is indicated for use by trained health care professionals (audiologists, physicians) and personnel (nurses, technicians) who are trained to operate the device under their supervision to perform otoacoustic emissions testing to assess cochlear function. The device can be used for patients of all ages, from 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/K121512
Methodology: https://510kreport.com/methodology