# K980533: Ero-Scan Otoacoustic Emissions Test Inst. (ER34)

- Pathway: 510(k) (Traditional)
- Applicant: Etymotic Research
- Decided: Mar 23, 1998 after 40 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: 1 generation back to K930553 (1993). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K930553: Cub Dis Otoacoustic Emissions Test Instrument, Etymotic Research (1993) Summary page 1.

## Most influential descendants
- K112733: ER35 Ero-Scan Pro Hearing Test System (2011), 0 descendants of its own
- K070880: ER35 Ero-Scan Pro Hearing Test System (2007), 0 descendants of its own

## Indications for use
The EROeSCAN Otoacoustic Emissions Test Instrument is a hand-held auditory test instrument designed to evoke or stimulate the generation of distortion product otoacoustic emissions (DPOAEs), utilizing pure-tone stimulus presentation, for the purpose of determining the presence of cochlear function in adults, children and infants. Otoacoustic emissions are low-level audio-frequency sounds that are produced by the cochlea as part of the normal-hearing process. Available evidence suggests that otoacoustic emissions are generated by the cochlea’s outer hair cells and that the presence of OAEs is an indication that the outer hair cells are viable. Clinical evidence indicates that these emissions normally occur with normal hearing or, at most, mild hearing loss (usually 30-40 dB HL). The majority of hearing-impaired individuals will be identified by a simple OAE test.

Source page: https://510kreport.com/device/K980533
Methodology: https://510kreport.com/methodology