Who else makes this device?

Name: Bio-Logic Scout Sport
Brand: Bio-Logic Scout Sport

Ear Nose & Throat › DiagnosticAudiometer

Bio-Logic Scout Sport

Scout is a PC-based measurement system that performs otoacoustic emissions tests. Using a combination of hardware and software, each system produces a controlled acoustic signal in the ear…

Registry build 21.09.26

Scout is a PC-based measurement system that performs otoacoustic emissions tests. Using a combination of hardware and software, each system produces a controlled acoustic signal in the ear canal and measures the resulting otoacoustic emission that is generated by outer hair cells in the cochlea. 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 Bio-Logic Scout Sport
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: Atmospheric Pressure: <81kPA (<2000 meters); Special storage condition: Storage Humidity: 0-90% at 65 C; Special storage condition: Operating Humidity: 15%-95% at 40 C; Storage environment temperature -20 to 70 °C; Special storage condition: Operating Condition: 15-40 C
Distribution end date	2026-01-07

Catalogue Numbers

Catalogue numbers for Bio-Logic Scout Sport
Catalogue number	Size	Status
580-SPBOX1001		Withdrawn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.