# K123624: Otostat Dpoae + Mepa Measurement System

- Pathway: 510(k) (Special)
- Applicant: Mimosa Acoustics, Inc.
- Decided: Mar 28, 2013 after 125 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 K981460 (1998). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981460: Cub Dis II Dpoae Measurement System, Mimosa Acoustics, Inc. (1998) Summary page 1.
- K053216: Hearid Wideband Middle Ear Power Analyzer, Mimosa Acoustics, Inc. (2006) Summary page 1.

## Indications for use
The intended use of the OtoStat DPOAE Measurement is to determine the presence of cochlear function. The intended use of the OtoStat MEPA Middle Ear Power Analyzer is to characterize the middle ear status and to assist in diagnosing middle ear pathologies. The intended use of the OtoStat DPOAE+MEPA is to determine the presence of cochlear and middle ear functions and to assist in differential diagnosis between cochlear and middle ear dysfunctions. The OtoStat MEPA system measures various acoustic properties of the ear, namely power reflectance, power absorbance, transmittance, wideband inimittance, and equivalent ear canal volume. These measures allow the evaluation of the functional condition of the middle and outer ear. The device is suitable for all populations including new-born infants. The device is to be used by trained personnel only.

Source page: https://510kreport.com/device/K123624
Methodology: https://510kreport.com/methodology