FDA.reportPublic FDA data

Bone Vibrator Peidatric Head Band

Primary DI
00817020020655
Brand
Bone Vibrator Peidatric Head Band
Company
INTELLIGENT HEARING SYSTEMS CORP.
Model
M014430
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
00817020020655PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817020020655008170200206558170200206550817020020655

GMDN Terms#

Term, Definition table
TermDefinition
Bone vibratorAn electromechanical transducer intended to produce the sensation of hearing by vibrating the cranial bones. It can be used as an output device with an audiometer to measure bone-conduction hearing thresholds, and thus serve as an adjunct to air-conduction testing with conventional earphones. Comparison of the results enables the clinician to distinguish hearing loss attributable to the external or middle ear (conductive loss) from the inner ear (sensory loss). In addition, this device may be used to provide output for a hearing aid for patients who cannot wear an earmould.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
154870455
Device count
1
Premarket exempt
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817020020723Screener CartM998920S2026-06-10
00817020020990Trigger Out Cable for USB Jr DuetM0131532026-06-10
00817020021027Toy Cabinet (Small)M025400S2026-06-10
00817020021034Bone Vibrator w/Cable and Headband (B71)M0111142026-06-10
00817020021089DD45-300 Headphones with Pediatric HeadbandM0150562026-06-10
00817020021096DD45-300 Headphones with Easy Adjust HeadbandM0150572026-06-10
00817020021119Reusable Safety Snap Leads 40" (3) for Duet/Aria/SoloM013933S2026-06-10
00817020021133OAE Probe OP23M0322002026-06-10
00817020021140Diagnostic CartM998920D2026-06-10
00817020021218DD450 HF HeadphonesM0150602026-06-10
00817020021225DD45S (10 Ohms) HeadphonesM0150802026-06-10
00817020021232DD45S (10 Ohms) Headphones with Pediatric HeadbandM0150812026-06-10
00817020021249DD45S (10 Ohms) Headphones with Easy Adjust HeadbandM0150822026-06-10
00817020020280Capella2 OAE Start-Up Kit8-69-428002026-06-09
00817020021003B81 Bone VibratorM0144022026-06-09
00817020021010B81 Bone Vibrator CableM0144032026-06-09
00817020021164Bone Vibrator w/Cable and Headband (B81) for AriaM0144052026-06-09
00817020021171Bone Vibrator Cable for AriaM0144062026-06-09
00817020020044Lilly TM-Wick Electrode CableM0139142016-09-24
00817020020068eABR Cable for USB Jr DuetM0131522016-09-24

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