# K231545: hearOAE

- Pathway: 510(k) (Traditional)
- Applicant: Hearx SA (Pty), Ltd.
- Decided: Oct 27, 2023 after 150 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 K983350 (1998). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983350: ILO292 DP Echoport Plus Oae System, Otodynamics, Ltd. (1998) Summary page 4.

## Indications for use
hearOAE is intended to be used by hearing healthcare professionals in the audiologic evaluation and documentation of ear function and ear disorders using Transient Evoked Otoacoustic Emissions (TEOAEs) and Distortion Product Otoacoustic Emissions (DPOAEs). The target population for the hearOAE includes all ages.

Source page: https://510kreport.com/device/K231545
Methodology: https://510kreport.com/methodology