FDA.reportPublic FDA data

Earscan 3

Primary DI
00862185000325
Brand
Earscan 3
Company
MICRO AUDIOMETRICS CORPORATION
Model
ES3
Catalog number
05.001
Device description
Earscan 3 Automatic Threshold Audiometer.
Published
2016-09-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe

Contact Domains#

Product Codes#

Code, Name table
CodeName
EWOAudiometer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EWOAudiometerEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00862185000325PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00862185000325008621850003258621850003250862185000325

GMDN Terms#

Term, Definition table
TermDefinition
Tone audiometer, automatedAn electroacoustic device designed to be used in a clinical setting to measure the hearing threshold of a patient by presenting tones of increasing or decreasing intensity through headphones to establish the level at which the patient first becomes aware of the sounds. A computer or microprocessor in the device automatically produces tones that sweep the audiometric scale and controls tone intensity and frequency. The device also records the patient's responses and may display calculated hearing thresholds. This device may have the capacity to present a fixed frequency or a steadily changing frequency. It may also provide both continuous and pulsed tone outputs.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
866-327-7226support@microaud.com

Regulatory Flags#

DUNS number
048573265
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00862185000301Earscan 3ES3M06.0012016-09-07
00862185000318Earscan 3ES3S04.0012016-09-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
057133150000581052 OTOsuiteNatus Medical Denmark ApSEWO2026-06-22
057133150007511066 OTOsuiteNatus Medical Denmark ApSEWO2026-06-22
057133150007681052 OTOsuiteNatus Medical Denmark ApSEWO2026-06-22
00817020020723Screener CartINTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-10
00817020021027Toy Cabinet (Small)INTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-10
00817020021034Bone Vibrator w/Cable and Headband (B71)INTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-10
00817020021089DD45-300 Headphones with Pediatric HeadbandINTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-10
00817020021096DD45-300 Headphones with Easy Adjust HeadbandINTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-10
00817020021133OAE Probe OP23INTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-10
00817020021140Diagnostic CartINTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-10
00817020021218DD450 HF HeadphonesINTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-10
00817020021225DD45S (10 Ohms) HeadphonesINTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-10
00817020021232DD45S (10 Ohms) Headphones with Pediatric HeadbandINTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-10
00817020021249DD45S (10 Ohms) Headphones with Easy Adjust HeadbandINTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-10
00817020020280Capella2 OAE Start-Up KitINTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-09
00817020021003B81 Bone VibratorINTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-09
00817020021010B81 Bone Vibrator CableINTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-09
00817020021164Bone Vibrator w/Cable and Headband (B81) for AriaINTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-09
00817020021171Bone Vibrator Cable for AriaINTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-09
00810046707562Grason-StadlerDiagnostic Group LLCEWO2026-06-04
05745000311064OscillaOscilla A/SEWO2026-05-29
05745000311095OscillaOscilla A/SEWO2026-05-29
05745000311156OscillaOscilla A/SEWO2026-05-29
05745000311163OscillaOscilla A/SEWO2026-05-29
05745000311187OscillaOscilla A/SEWO2026-05-29
05745000311200OscillaOscilla A/SEWO2026-05-29
00810046707180Grason-StadlerDiagnostic Group LLCEWO2026-04-06
057117810041053000 Real EarAuditdata A/SEWO2026-01-23
057117810041363000 Real EarAuditdata A/SEWO2026-01-23
057117810041433000 Real EarAuditdata A/SEWO2026-01-23