# K060539: DPOAE20 , Eclipse

- Pathway: 510(k) (Traditional)
- Applicant: Interacoustics A/S, Assens
- Decided: May 30, 2006 after 90 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
No predicates in its family tree.
7 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K103760: TITAN (2011), 5 descendants of its own
- K130795: TITAN (2013), 4 descendants of its own
- K171506: Easyscreen (2017), 1 descendant of its own
- K191372: Lyra (2019), 0 descendants of its own
- K173567: Sera (2018), 0 descendants of its own

## Indications for use
The Interacoustics DPOAE20 system is for use in the audiologic evaluation and documentation of ear disorders using Distortion Product Otoacoustic Emission tone stimuli. The presence of Otoacoustic emissions suggests normal outer hair cell function within cochlea, which in turn suggests normal hearing. OAEs are recorded using an OAE probe which is placed in the ear canal. The OAE response from the ear.is recorded and processed by the Eclipse and the DPOAE2O software and then displayed on the computer screen for evaluation. This is of.particular interest to Ear, Nose, and Throat doctors, Neurology specialists, Audiologist and other health- professionals concerned with measuring auditory functions. The patient group includes all ages and sexes.

Source page: https://510kreport.com/device/K060539
Methodology: https://510kreport.com/methodology