# K053216: Hearid Wideband Middle Ear Power Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Mimosa Acoustics, Inc.
- Decided: Feb 10, 2006 after 85 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K123624: Otostat Dpoae + Mepa Measurement System (2013), 0 descendants of its own
- K121847: TITAN (2012), 0 descendants of its own

## Indications for use
The intended use of the HearID-wbMEPA Middle Ear Power Analyzer is to characterize the middle ear status and to assist in diagnosing middle ear pathologies. The HearlD-wbMEPA system measures various acoustic properties of the ear, namely power reflectance, power absorption, transmittance, reflectance group delay, complex acoustic impedance and admittance, and equivalent ear canal volume. These measures allow the evaluation of the functional condition of the middle and outer ear. The devices are suitable for all populations including new-born infants. The devices are to be used by trained personnel only. The HearID system comes in two versions: flearID-b-wbMEPA, and HearID e-wbMEPA, where the difference is the variation of the hardware platform.

Source page: https://510kreport.com/device/K053216
Methodology: https://510kreport.com/methodology