# K141446: Echo-Screen Iii Pro Hearing Screener with Barcode Scanner, Echo-Screen Iii Pro Hearing Screener Without Barcode Scanner,

- Pathway: 510(k) (Special)
- Applicant: Natus Medical Incorporated
- Decided: Aug 22, 2014 after 81 days
- Product code: GWJ (Stimulator, Auditory, Evoked Response)
- Device class: 2
- Regulation: 21 CFR 882.1900
- 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.
No later device cites it as a predicate yet.
0 of 12 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 4.

## Indications for use
The Echo-Screen III hearing screener models are based upon otoacoustic emission (OAE) and auditory brainstem response (ABR) technology. The device is intended to screen hearing for newborns through adults, including geriatric patients. The device does not measure hearing per se, but helps to determine whether or not a hearing loss may be present. The Echo-Screen III product family consists of handheld, automated OAE and ABR based hearing screening systems which are easy to use. The measurement flow is menu guided and the evaluation is based upon signal statistics. The Echo-Screen III devices are intended to be used by trained personnel in a medical or school environment. The Echo-Screen III models are not intended for fitting assistive listening devices such as hearing aids or cochlear implants.

Source page: https://510kreport.com/device/K141446
Methodology: https://510kreport.com/methodology