# K122496: Audx Pro Otoacoustic Emissions Measurement System

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Logic Systems Corp.
- Decided: Nov 1, 2012 after 77 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 K930328 (1993). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111618: Audx Otoacoustic Emissions Measurement System with Audx I/O Function, Natus Medical Incorporated (2011) Summary page 3.
- K112247: A Baer with Abaer I/O Function, Natus Medical Incorporated (2012) Summary page 3.
- K072033: Otodynamics Otoport, Otodynamics, Ltd. (2007) Summary page 1.

## Indications for use
The AuDX Pro Otoacoustic Emissions Measurement System delivers controlled acoustic signals in the ear canal and measures the resulting evoked otoacoustic emissions (OAEs) that are generated by the outer hair cells of the inner ear. The AuDX Pro device performs transient evoked otoacoustic emissions (TEOAE) and distortion product otoacoustic emissions (DPOAE) tests. AuDX Pro is indicated for use by trained health care professionals (audiologists, physicians) and personnel (nurses, technicians) who are trained to operate the device under their supervision to perform otoacoustic emissions testing to assess cochlear function. The device can be used for patients of all ages, from newborn infants through adults, to include geriatric patients. The otoacoustic emissions test is especially indicated for use in testing individuals for whom behavioral results are deemed unreliable, such as infants, young children, and cognitively impaired adults.

Source page: https://510kreport.com/device/K122496
Methodology: https://510kreport.com/methodology