# K112733: ER35 Ero-Scan Pro Hearing Test System

- Pathway: 510(k) (Traditional)
- Applicant: Etymotic Research, Inc.
- Decided: Dec 16, 2011 after 87 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 K930553 (1993). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980533: Ero-Scan Otoacoustic Emissions Test Inst. (ER34), Etymotic Research (1998) Summary page 1.
- K010165: Ero Scan Oae Test System, Etymotic Research (2001) Summary page 1.
- K000097: Gsi 2000 Middle Ear Analyzer, Grason-Stadler, Inc. (2000) Summary page 1.
- K994254: Interacoustics AT235 Impedance Audiometer, International Distributors of Electronics For Medi (2000) Summary page 1.

## Indications for use
The ER35 ERO-SCAN Pro Hearing Test System is indicated for testing of cochlear and middle ear function in infants, children, and adults by measuring otoacouIStic emnissions (OAEs). tympanomretry. and acoustic reflex.

Source page: https://510kreport.com/device/K112733
Methodology: https://510kreport.com/methodology