# K964426: Smartoae

- Pathway: 510(k) (Traditional)
- Applicant: Intelligent Hearing Systems
- Decided: Feb 3, 1997 after 90 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.
2 later devices descend 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K061443: Smart Usblite, Model M011120 (2006), 1 descendant of its own
- K193033: GSI Audera Pro (2020), 0 descendants of its own

## Indications for use
The SmartOAE device is intended to be used for the purpose of determining the distortion product response of the human cochlea. The device is intended to be used by hearing health professionals to determine cochlear function. The test administered by the device does not require any patient behavioral response, such as pushing a button switch. The device delivers sound signals into the outer ear and subsequently records the sound in the outer ear which contain sounds produced by normal cochleas. The device also measures the level of sound near the distortion product frequency to estimate the noise level present while the test was performed.

Source page: https://510kreport.com/device/K964426
Methodology: https://510kreport.com/methodology