# K070880: ER35 Ero-Scan Pro Hearing Test System

- Pathway: 510(k) (Traditional)
- Applicant: Etymotic Research, Inc.
- Decided: Jun 7, 2007 after 69 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). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 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.
- 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 (ER35) is indicated for testing of cochlear and middle ear function in infants, children, and adults by measuring otoacoustic emissions (OAEs) and tympanometry.

Source page: https://510kreport.com/device/K070880
Methodology: https://510kreport.com/methodology