# K111618: Audx Otoacoustic Emissions Measurement System with Audx I/O Function

- Pathway: 510(k) (Traditional)
- Applicant: Natus Medical Incorporated
- Decided: Dec 28, 2011 after 201 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: 5 generations back to K930328 (1993). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021801: Bio-Logic Abaer Cub with Integrated Oae & Abr Functions, Bio-Logic Systems Corp. (2002) Summary page 1.
- K964132: Modification to Otoacoustic Emissions (OAE0 Test Instrument, Bio-Logic Systems Corp. (1997) Summary page 1.
- K974076: Sport/Audx Oae Test Instrument with Bio-Logic Ear Probe, Bio-Logic Systems Corp. (1998) Summary page 1.
- K072033: Otodynamics Otoport, Otodynamics, Ltd. (2007) Summary page 1.

## Most influential descendants
- K122496: Audx Pro Otoacoustic Emissions Measurement System (2012), 0 descendants of its own

## Indications for use
The AuDX Otoacoustic Emissions Measurement System produces 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 as a result of normal peripheral hearing processes. The AuDX device performs both transient evoked otoacoustic emissions (TEOAE) and distortion product otoacoustic emissions (DPOAE) tests that can be utilized in hearing screening and diagnostic test environments. The AuDX I/O is a software option intended to provide additional diagnostic capability and to be used in conjunction with the AuDX system. The AuDX I/O software option enables the AuDX device user to perform DPOAE testing at different stimulus intensities in order to obtain the 'DPOAE Input / Output (I/O) function' at different test frequencies, frequency ratios and intensity levels. The graphical representation of the test results in the form of stimulus level presented versus measured DPOAE level at each tested frequency provides an effective way for the user to view and evaluate stimulus level-sensitive information about DPOAE responses. As an OAE based screening tool, AuDX is indicated for use by any personnel (nurses, technicians, volunteers) who are trained to operate the device for the purpose of performing an objective, automated physiologic screening measure with pass/refer result requiring no further clinical interpretation. Additionally, as a tool that can provide diagnostic information, the device is indicated for use by trained health care professionals (audiologists, physicians) for the purpose of further assessing cochlear function in the diagnosis and treatment of hearing disorders, since additional information may be obtained by viewing the details of the performed otoacoustic emissions test and by obtaining the DPOAE I/O functions. 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/K111618
Methodology: https://510kreport.com/methodology