Ear And Skull Base Center, Inc. — Department of Health and Human Services STTR Phase I: NIDCD

Description

DESCRIPTION provided by applicant Each year million Americans go to health care providers because of vertigo dizziness or balance problems It is the second most common complaint heard in doctorandapos s offices and will occur in of the nationandapos s population at sometime in their lives From through of US adults aged years and older million Americans had vestibular dysfunction Gravitational receptor asymmetry produces dizziness while rotational receptor asymmetry produces true rotational vertigo Gravitational receptor function currently can be measured with air conduction vestibular evoked myogenic potentials VEMPs however these systems are time consuming may not produce consistent responses and cannot be used in many pediatric patients elderly patients or those with conductive hearing losses There currently is no FDA approved or cleared method to measure gravitational receptor function Likewise there is no portable system that could screen patients for existing gravitational receptor dysfunction or drug induced ototoxicity The proposed research in Phase I will assess the feasibility proof of principle of an innovative method to deliver bone conducte force stimulation and measurement of cervical vestibular evoked myogenic potentials cVEMP and ocular VEMPs oVEMP responses Our proposed product is a bone conduction VEMP device measuring both saccular and utricular gravity receptor function cVEMP and oVEMP respectively We have named this the StrikeVEMP The innovation of the proposed StrikeVEMP system is to accurately measure gravitational receptor function with greater consistency speed portability generate input output functions and with unparalleled post test data analysis The development of automated screening devices using otoacoustic emissions or auditory brainstem response testing and placing them in the hands of nurses caring for their patients in the hospital transformed universal infant hearing screening The same may prove to be true if a version of the StrikeVEMP device can be developed as an automated system but for screening for hospital falls or ototoxicity associated with chemotherapy or antibiotic administration Results of this Phase I research will be essential to translate this promising technology into a reliable efficient FDA cleared and low cost product that improves transparency and communication between VEMP laboratories and therefore will speed the discovery of functional diagnostic utility for patient care This work will be completed in Phase II and Phase III The commercial market for this product includes not only otolaryngology and audiology practices but also every hospital in the world that is interested in monitoring gravitational receptor functin during ototoxic treatment e g chemotherapy or ototoxic antibiotic administration and in reducing hospital falls For the future Phase II STTR proposal focused on the commercialization plan additional clinical studies will be designed A new cohort of Consultants have been added to help provide advice in designing the additional clinical studies that will be needed vestibular disorders and VEMPs Carey Agrawal Janky and Welgampola mild traumatic brain injury and military blast injury Balaban aging and hospital falls Agrawal and Maxwell pediatric vestibular disorders and assessment Janky ototoxicity monitoring Konrad Martin and nursing research Maxwell PUBLIC HEALTH RELEVANCE Each year million Americans go to health care providers because of vertigo dizziness or balance problems It is the second most common complaint heard in doctorandapos s offices and will occur in of the nationandapos s population at sometime in their lives From through of US adults aged years and older million Americans were found to have vestibular dysfunction Gravity receptor function currently can be measured with air conduction acoustic vestibular evoked myogenic potentials VEMPs however these systems are time consuming may not produce consistent responses and cannot be used in many pediatric patients elderly patients or those with conductive hearing losses The proposed Phase I research will assess the feasibility of an innovative method to deliver bone conducted force stimulation and measurement of saccular and utricular gravity receptor function The commercial market for this product includes not only otolaryngology and audiology practices but also every hospital in the world that is interested in monitoring gravitational receptor function during chemotherapy treatment and in reducing hospital falls and monitoring ototoxicity The future Phase II studies as part of the commercialization plan will include clinical studies in patients with otologic conductive hearing loss and vestibular disorders mild traumatic brain injury and military blast injury aging and hospital falls pediatrc vestibular disorders and assessment ototoxicity monitoring and nursing research New Consultants have been added to complement the investigative team and established Consultants to help provide advice in designing the additional clinical studies to be performed in Phase II and if needed Phase III