# K982642: Echo-Screen

- Pathway: 510(k) (Traditional)
- Applicant: Fischer-Zoth Audiologic Systems, Inc.
- Decided: Oct 21, 1998 after 84 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: 2 generations back to K902540 (1990). 5 ancestors in all.
15 later devices descend from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974237: Gsi 70 Audiopath Screener, Grason-Stadler, Inc. (1998) Summary page 1.
- K962995: ILO88. Otodynamic Analyser, Kit System for PC, Otodynamics, Ltd. (1997) Summary page 1.

## Most influential descendants
- K013977: Echo-Screen T, TA, TD, Tda, TC (2002), 14 descendants of its own
- 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

## Indications for use
The Echo-Screen Otoacoustic Emissions Test Instrument is a hand-held instrument with an attached probe (that is placed in the outer ear canal) which emits sound that evokes otoacoustic emissions. A microphone in the probe picks up the emissions if any are present, and the device then analyzes the emissions and mathematically separates noise from cochlear emissions. The presence of these emissions indicates cochlear function in adults, infants and children. The instrument requires no active participation from the patient. Otoacoustic emissions (OAEs) are low-Jeve] audio-frequency sounds that are generated by the outer hair cells of the cochlea in response to sound input. The presence of OAE:s is an indication of cochlear function. If the Echo-Screen signals a “pass”™ reading as it analyzes the presence of OAEs, the clinician can determine that the cochlea is operating normally.

Source page: https://510kreport.com/device/K982642
Methodology: https://510kreport.com/methodology