# K063338: Hearid+TE Transient-Evoked Otoacoustic Emissions Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Mimosa Acoustics, Inc.
- Decided: Jan 4, 2007 after 59 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The intended use of the HearID+TE Transient-Evoked Otoacoustic Emissions Analyzer is to characterize inner-ear status and to assist in diagnosing inner-ear pathologies. The HearID+TE system measures various acoustic properties of the inner ear, namely otoacoustic emission sound pressure level, signal-to-noise ratio, and reproducibility. These three properties may be measured within prescribed frequency bands or wideband. These measures allow for the evaluation of the functional condition of the inner ear, assuming a normal middle and outer ear. The HearID+TE system is suitable for all populations, including newborn infants. The HearID+TE system is to be used by trained personnel only. The HearID system comes in two versions for use with different hardware platforms.

Source page: https://510kreport.com/device/K063338
Methodology: https://510kreport.com/methodology