# K061744: Cochlea-Scan / Cochlea-Scan Plus

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Logic Systems Corp.
- Decided: Sep 15, 2006 after 86 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: 4 generations back to K902540 (1990). 11 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013977: Echo-Screen T, TA, TD, Tda, TC, Fischer-Zoth Audiologic Systems, Inc. (2002) Summary page 1.

## Most influential descendants
- K133012: Sentiero (2014), 4 descendants of its own
- K171038: Hearing Healthcare Pro (2017), 1 descendant of its own
- K220139: QScreen (2022), 0 descendants of its own
- K213345: Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONE (2022), 0 descendants of its own
- K183201: Hearing Healthcare Pro (2019), 0 descendants of its own

## Indications for use
1. The Cochlea Scan is intended for use in automated objective hearing assessment using distortion product OAEs. 2. The Cochlea Scan is intended for use in diagnostic hearing evaluations and assistance in the diagnosis of possible hearing disorders by means of OAEs and/or pure tone audiometry. Hearing disorders include middle ear and cochlear hearing losses. 3. The results of the Cochlea Scan can be used to assist in the selection and/or (first-) fit of conventional hearing aids. It does not provide data for prescribing or fitting cochlear implants or middle ear implants. 4. The Cochlea Scan is intended for use in hearing screening using OAEs (with optional TEOAE module).

Source page: https://510kreport.com/device/K061744
Methodology: https://510kreport.com/methodology