Who else makes this device?

Name: Bio-Logic AudX
Brand: Bio-Logic AudX

Ear Nose & Throat › DiagnosticAudiometer

Bio-Logic AudX

The AuDX Otoacoustic Emissions Measurement System Basic box with DPOAE produces controlled acoustic signals in the earcanal and measures the resulting evoked otoacoustic emissions (OAEs)…

Registry build 21.09.26

The AuDX Otoacoustic Emissions Measurement System Basic box with DPOAE produces controlled acoustic signals in the earcanal 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.

2manufacturers in China registered for this device type

9catalogue numbers in this listing

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 Bio-Logic AudX
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	2018-12-18
Record revised	2026-01-09 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	serial number
Storage	Special storage condition: Pressure: <81kPA (<2000 meters); Special storage condition: Storage Humidity: 0-90% at 65 C; Special storage condition: Operating Humidity: 15%-95% at 40 C Non-Condensing; Storage environment temperature -20 to 70 °C; Special storage condition: Operating Temperature: 15-40 C
Distribution end date	2026-01-07

Catalogue Numbers

Catalogue numbers for Bio-Logic AudX
Catalogue number	Size	Status
580-AXPBOX-039		Withdrawn
014386		Withdrawn
580-AXPBOX-010		Withdrawn
580-AXPBOX-043		Withdrawn
580-AXBBOX-001		Withdrawn
580-AXPBOX-018		Withdrawn
580-AXBBOX-002		Withdrawn
580-AXPBOX-034		Withdrawn
014381		Withdrawn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.