Verifit Skull Simulator

GUDID B161VA3003

An optional accessory to the Audioscan Verifit VF-2 or Verifit VF-1 hearing aid analyzer or hearing instrument test (HIT) system. The VA-300 Verifit Skull Simulator is a measurement coupler operating in place of a standard acoustic coupler to facilitate measurement of the vibrational output produced by a bone conduction hearing aid. The device is intended as a direct substitute for the acoustic measurement coupler and uses the identical micro-power electrical interface.

Etymonic Design Incorporated

Bone vibrator mechanical coupler

• Primary Device ID: B161VA3003
• NIH Device Record Key: 193d3a62-a714-4de2-9f8c-3142d5df54a5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Verifit Skull Simulator
• Version Model Number: VA-300
• Company DUNS: 244780581
• Company Name: Etymonic Design Incorporated
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 81 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B161VA3000 [Primary]
HIBCC	B161VA3003 [Package]; Contains: B161VA3000; Package: Carton [1 Units]; In Commercial Distribution

FDA Product Code

• ETW: Calibrator, Hearing Aid / Earphone And Analysis Systems

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-10
• Device Publish Date: 2019-05-02

Devices Manufactured by Etymonic Design Incorporated

• B161RE3670 - Audioscan Probe Tube: 2020-01-23 Molded probe tube, consisting of a thin silicone tube, molded collar, and adjustable ring marker.
• B161VA3003 - Verifit Skull Simulator: 2019-05-10An optional accessory to the Audioscan Verifit VF-2 or Verifit VF-1 hearing aid analyzer or hearing instrument test (HIT) system. The VA-300 Verifit Skull Simulator is a measurement coupler operating in place of a standard acoustic coupler to facilitate measurement of the vibrational output produced by a bone conduction hearing aid. The device is intended as a direct substitute for the acoustic measurement coupler and uses the identical micro-power electrical interface.
• B161VA3003 - Verifit Skull Simulator: 2019-05-10 An optional accessory to the Audioscan Verifit VF-2 or Verifit VF-1 hearing aid analyzer or hearing instrument test (HIT) system
• B161AXIOM3 - Audioscan: 2018-03-29
• B161RM500SL3 - Audioscan: 2018-03-29 The RM500SL is a portable hearing aid analyzer intended to be used by hearing care professionals such as audiologists and hearin
• B161VERIFITVF20 - Audioscan: 2018-03-29