# K150491: ER36 Series OAE Test System

- Pathway: 510(k) (Special)
- Applicant: Etymotic Research, Inc.
- Decided: Mar 26, 2015 after 29 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 K010165 (2001). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010165: Ero Scan Oae Test System, Etymotic Research (2001) Summary page 4.

## Most influential descendants
- K180287: GSI Corti (2018), 0 descendants of its own

## Indications for use
The ER36 Series OAE Test System 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 or tones 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 OAE's 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 30-40dB HL). The majority of hearing-impaired individuals will be identified by a simple OAE test.

Source page: https://510kreport.com/device/K150491
Methodology: https://510kreport.com/methodology