# K143395: Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR Screener-Otocheck OAE+ABR, Otocheck OAE+ABR LE, Otocheck ABR Screener-Otodynamics ABR Upgrade Kit

- Pathway: 510(k) (Traditional)
- Applicant: Otodynamics, Ltd.
- Decided: Feb 23, 2015 after 89 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: 6 generations back to K902540 (1990). 18 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072033: Otodynamics Otoport, Otodynamics, Ltd. (2007) Summary page 5.
- K024205: Audioscreener Oae+Abr, Everest Biomedical Instruments Co. (2003) Summary page 5.
- K132957: Madsen Accuscreen Type 1077, Gn Otometrics (2014) Summary page 5.

## Most influential descendants
- K234095: OtoNova/OtoNova Pro (2024), 0 descendants of its own
- K240430: Otoport Pro (2024), 0 descendants of its own

## Indications for use
The Otodynamics Otoport/Otocheck OAE+ABR device is indicated for use when there is a requirement to screen for hearing disorders by objective and non-invasive means. ABR, TEOAE and DPOAE screening test results are automatically interpreted and a clear ‘Pass’ or ‘Refer’ result is presented to the user who will be a trained screener, audiologist or medical professional. Use of the device is indicated when the patient is unable to give reliable voluntary responses to sound, especially with infants. Use of the device facilitates the early detection of hearing loss and its characterization. The TEOAE and DPOAE analytical functions of the device are indicated when objective non-invasive clinical investigations require the characterization and monitoring of the functional status of the peripheral auditory function. For this purpose the device is intended to be used by audiologists or other audiologically skilled professionals. These TEOAE and DPOAE tests are applicable to populations of any age to obtain objective evidence of peripheral auditory function.

Source page: https://510kreport.com/device/K143395
Methodology: https://510kreport.com/methodology