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Computerized Rotational Head Impulse Test-Vertical (crHIT-vertical)

Award Number: R44DC014611
ORGANIZATION: NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 04/01/2015
PERIOD OF PERFORMANCE END DATE: 05/31/2023

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Computerized Rotational Head Impulse Test-Vertical (crHIT-vertical) - Project Title Computerized Rotational Head Impulse Test-Vertical crHIT Project Summary This proposal extends the proof of concept achieved in our SBIR Phase I studies. The goal of this Phase II SBIR proposal is to develop a clinically-suitable version of the hardware and software and test 120 control subjects and 66 patients to support the functionality of the vertical crHIT test for clearance by the FDA and commercial use. The immediate goals of this Phase II SBIR are described by the five Specific Aims of this application. The first aim is to build two retrofit kits for the FDA-approved I-Portal® Neuro-Otologic Test Center (NOTC) and one lower-cost, next-generation NOTC system capable of running vertical and horizontal crHIT. These systems will be installed in three Medical Centers: University of Pittsburgh Medical Center, Miami Medical Center and Mayo Clinic. The second specific aim will concentrate on developing a method for aligning each patient's head for testing all canals and clinical software integrated to hardware with the test protocol in the commercially-available VEST™ software. The third specific aim will focus on clinical testing. Total population to be enrolled in this study: 120 controls and 66 patients for a total study cohort of 186 subjects. 66 patients will include: 30 with surgically confirmed unilateral loss for validation, 15 with absent ice water calorics from vestibular neuritis, and 21 with diagnosed vestibular migraine for evaluation sensitivity and specificity of test. During clinical testing we also plan to evaluate subject's discomfort with these stimuli. The focus of the current experiments will be to obtain an evaluation of general comfort level and the potential for the vertical crHIT stimuli to evoke motion sickness symptoms. After testing and data analysis are complete we will submit results of testing to the FDA for 510K clearance (specific aim #4). FDA approval will allow us to commercially sell the vertical crHIT test to vestibular and concussion clinics. Specific aim #5 is the final report.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2018	NEUROLIGN USA LLC	128 GAMMA DR	BLAWNOX	PA	15238	ALLEGHENY	USA	Research Related to Deafness and Communication Disorders	000	3	9/28/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $0 )
2022	2018	NEUROLIGN USA, LLC	128 GAMMA DR	PITTSBURGH	PA	15238	ALLEGHENY	USA	Research Related to Deafness and Communication Disorders	000	3	4/16/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $0 )
2021	2018	NEURO KINETICS, INC.	128 GAMMA DR	PITTSBURGH	PA	15238	ALLEGHENY	USA	Research Related to Deafness and Communication Disorders	000	3	6/25/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $0 )
2020	2018	NEURO KINETICS, INC.	128 GAMMA DR	PITTSBURGH	PA	15238	ALLEGHENY	USA	Research Related to Deafness and Communication Disorders	000	3	7/14/2020	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2018 ( Subtotal = $515,110 )
2018	2018	NEURO KINETICS, INC.	128 GAMMA DR	PITTSBURGH	PA	15238	ALLEGHENY	USA	Research Related to Deafness and Communication Disorders	000	3	8/15/2018	NON-COMPETING CONTINUATION	$515,110
														Subtotal = $515,110

Issue Date FY: 2017 ( Subtotal = $653,205 )
2017	2017	NEURO KINETICS, INC.	128 GAMMA DR	PITTSBURGH	PA	15238	ALLEGHENY	USA	Research Related to Deafness and Communication Disorders	000	2	9/18/2017	COMPETING CONTINUATION	$653,205
														Subtotal = $653,205

Grand Total All Awards = $1,168,315

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Computerized Rotational Head Impulse Test-Vertical (crHIT-vertical)

Award Number: R44DC014611

ORGANIZATION: NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 04/01/2015

PERIOD OF PERFORMANCE END DATE: 05/31/2023

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