Who else makes this device?

Name: AuDX Pro Otoacoustic Emissions Measurement System
Brand: AuDX Pro Otoacoustic Emissions Measurement System

Ear Nose & Throat › DiagnosticAudiometer

AuDX Pro Otoacoustic Emissions Measurement System

The AuDX Pro Otoacoustic Emissions Measurement System is a handheld battery operated device that performs otoacoustic emissions tests. Connection to the patient's ear is via the Bio-logic…

Registry build 21.09.26

The AuDX Pro Otoacoustic Emissions Measurement System is a handheld battery operated device that performs otoacoustic emissions tests. Connection to the patient’s ear is via the Bio-logic ear probe. Using a combination of hardware and software, the system produces a controlled acoustic signal in the ear canal and measures the resultiing evoked emissions that are generated by the outer hair cells of the inner ear associated with normal cochlear function. The stimuli are presented via miniature receivers and the acoustic response in the external ear canal is recorded via a miniature microphone, all embedded in the Bio-logic OAE probe. The system collects and averages data samples until specified measurement parameters are achieved.

2manufacturers in China registered for this device type

1catalogue number

2510(k) clearances naming this product code

Who Else Makes It

All of them in Zhejiang.

Chinese manufacturers registered for FDA product code EWO
Manufacturer	City	Province	Registered as	Device types
Fastsound Acoustic Technology (Hangzhou) Co., Ltd.	Hangzhou	Zhejiang	Manufacturer	6
Zoomax Technology Co., Limited	Hangzhou	Zhejiang	Contract manufacturer	5

Record

Regulatory record for AuDX Pro Otoacoustic Emissions Measurement System
Listed by	Natus Medical Incorporated, United States
FDA product code	EWO
Device type	Audiometer
Device class	Class 2
Regulation	21 CFR 874.1050
Establishment	Specification developer, Complaint-file establishment, Manufacturer
Record published	2017-09-11
Record revised	2026-01-09 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Label carries	manufacturing date, serial number
Storage	Storage environment temperature -20 to 70 °C; Handling environment temperature 15 to 40 °C
Distribution end date	2026-01-07

Catalogue Numbers

Catalogue numbers for AuDX Pro Otoacoustic Emissions Measurement System
Catalogue number	Size	Status
AuDX Pro		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
RadioEar A/S	Interacoustics A/S	131
GN Otometrics A/S	Natus Medical Denmark ApS	88
Audiometer	Etymotic Research, Inc.	73
Siemens	WS Audiology USA, Inc.	57
Bio-logic	Natus Medical Incorporated	33
Welch Allyn, Inc.	Welch Allyn, Inc.	29
Real-EAR	WS Audiology USA, Inc.	26
Sanibel Supply A/S	Interacoustics A/S	18
Natus	Natus Medical Incorporated	14
Grason-Stadler	Diagnostic Group LLC	12
Interacoustics	Interacoustics A/S	12
Oscilla	Inmedico A/S	12

Showing 12 of 348. All products under Audiometer

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K112247	2012-04-02
K111618	2011-12-28

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.