CREARE LLC — Department of Health and Human Services SBIR Phase I: NIDCD

Description

PROJECT SUMMARY ABSTRACTAccording to a recent study on health disparities and hearing lossAmerican Indians and Alaska NativesAIANhave the highest rate of hearing difficulty across all the race ethnicity groups studiedA significant portion of the hearing loss among AIAN is conductive in nature in part due to the disproportionate prevalence of otitis media in this populationUnfortunatelyfor many in these communitiesaccess to hearing healthcare is difficult because they often live in very remote areasThe difficulty stems from the fact that diagnostic hearing tests currently require a sound booth to reduce ambient noiseDue to their cost and sizesound booths are typically fixed installations and patients must travel far to reach facilities with this equipmentThusaccess to hearing healthcare in remote and rural areas is a known health disparityThis disparity is further compounded for AIAN populations by the high prevalence of middle ear pathologies which can lead to permanent hearing loss and medical complications if left untreatedTo address this public health issueCreare proposes to develop a Mobile Audiometric Diagnostic System that will enable both airand bone conduction diagnostic hearing tests outside the sound boothmaking timely hearing healthcare accessible to communities that live in remote areas where audiologists are available through telehealthThe device we propose provides ambient noise attenuation through a specially designed headset and integrates the audiometerheadphones and bone vibrators into oneeasy to use deviceAutomated algorithms further enhance the system by allowing basic diagnostic assessment to be performed by a health technician aide or nurseIntegration of our system with existing telehealth systems allows audiologists to review andif neededcontrol the hearing tests remotely for full diagnostic capabilityDuring Phase Iwe will demonstrate the feasibility of our innovation by building a prototype and testing its performance against standard clinical audiology practiceDuring Phase IIwe will refine the design of our devicebuild several integrated prototypesand demonstrate their use and performance with several human subject studies in target locations and populationsThe Creare team is extremely well qualified to successfully develop and commercialize this Mobile Audiometric Diagnostic SystemOur system is made possible by leveraging hardware and software that Creare previously developed for hearing assessment in varied settings as well as the expertise of clinical and research audiologists who work to address existing disparities in hearing healthcarein particular with rural and AIAN populations PROJECT NARRATIVEHearing loss is a leading public health concernwith aboutof American adults reporting some degree of hearing lossand the likelihood of having hearing loss in American Indian or Alaska NativeAIANpeoples is two to four times higher than in other American subpopulationsAccess to hearing healthcare is particularly difficult for people living in remote and rural areasfurther compounding the impact of hearing diseases on AIAN populationsDuring the proposed effortwe will develop innovative technology that will enable new hearing assessment paradigms to reach underserved communities and expand hearing diagnostic tests to a wide array of locationsand lower the cost of hearing healthcare