# K013977: Echo-Screen T, TA, TD, Tda, TC

- Pathway: 510(k) (Traditional)
- Applicant: Fischer-Zoth Audiologic Systems, Inc.
- Decided: Jun 14, 2002 after 193 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: 3 generations back to K902540 (1990). 10 ancestors in all.
14 later devices descend from it; 6 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982642: Echo-Screen, Fischer-Zoth Audiologic Systems, Inc. (1998) Summary page 1.
- K993177: SABRE, Sle Limited (1999)

## Most influential descendants
- K122067: Type 1077 Accuscreen (2012), 9 descendants of its own
- K061744: Cochlea-Scan / Cochlea-Scan Plus (2006), 5 descendants of its own
- K133012: Sentiero (2014), 4 descendants of its own
- K132957: Madsen Accuscreen Type 1077 (2014), 3 descendants of its own
- K143395: Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR Screener-Otocheck OAE+ABR, Otocheck OAE+ABR LE, Otocheck ABR Screener-Otodynamics ABR Upgrade Kit (2015), 2 descendants of its own

## Indications for use
The Fischer-Zolh Audiologic Systems model family “Echo-Screen T“ consisting of Echo-screen T, Echo-Screen ?’A, Echo-Screen TD, Echo-Screeii TDA and Echo-Screen TC are based upon Otoacoustic Emissions (OAE) and Auditory Brainstein Response (AHR) technology. The device is intended to screen hearing for newborns through adults, including geriatric patients. ?“he device does not ineasure hearing per se, but helps to determine whether or not a hcaring loss may be present. ‘The “13cho-Screen 7”’ product family consists of handheld, autoinated OAE and AM< based heariiig screening systems which are easy to use. The measurement flow i s tticml guidcd and the evaluation is based upon signal statistics. The “Echo-Screen T“ deviccs are intended to be used by trained personriel in a medical or scltooi environment. ‘l‘hc “Echo-Screen ‘T” inodeis are not intended for fitting assistive listening dcvices such as hcaring aids or cochlcar implants.

Source page: https://510kreport.com/device/K013977
Methodology: https://510kreport.com/methodology