# K180287: GSI Corti

- Pathway: 510(k) (Traditional)
- Applicant: Grason-Stadler, Inc.
- Decided: May 11, 2018 after 99 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 K010165 (2001). 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)
- K150491: ER36 Series OAE Test System, Etymotic Research, Inc. (2015) Summary page 4.

## Indications for use
The GSI Corti series is indicated for testing of cochlear function in infants, children and adults by measuring otoacoustic emissions (OAEs). The OAEs are generated by a series of clicks that are directed into the ear canal. Otoacoustic emissions are low level audio-frequency sounds that are produced by the cochlea as part of the normal-hearing process. Available evidence suggests that otoacoustic emissions are generated by the cochlea’s outer hair cells and that the presence of OAEs is an indication that the outer hair cells are viable. Clinical evidence indicates that these emissions normally occur with normal hearing, or at most, mild hearing loss (usually 30-40 dB HL). The majority of hearing-impaired individuals will be identified by a simple OAE test.

Source page: https://510kreport.com/device/K180287
Methodology: https://510kreport.com/methodology