CREARE LLC — Department of Health and Human Services SBIR Phase II: Y

Description

DESCRIPTION provided by applicant Hearing loss is a leading public health concern with about of American adults reporting some degree of impairment Of those fewer than seek help for their condition for a variety of reasons To address this issue the National Institue of Deafness and Other Communication Disorders NIDCD is seeking solutions to improve hearing healthcare access and lower its cost Solutions include enabling currently available commodities telephone Internet and smartphones to conduct surveillance of hearing loss Internet screening systems and DPOAE screening to be used beyond traditional clinical environments Creare proposes to complete development of a hearing screening device that measures Otoacoustic Emissions and is controlled through a mobile platform Our device is designed for use in remote and non traditional locations with limited personnel and resources as well as for widespread infant screening in the developing world OAE measurements can be successfully obtained even in noise environments thanks to our noise rejection algorithms as well as a design that enables the use of attenuating earmuffs over the probe to further reduce external noise The device is designed for low cost manufacturing and results in a screening system that is cost competitive with even the lowest cost audiometric screeners used in schools The resulting device will provide a solution to the problem of hearing healthcare access for populations who are unable to provide behavioral responses by allowing wide scale screening in public health programs and humanitarian efforts as well as in remote locations where minimal resources are available In addition because it is designed for use with mobile platforms and is calibrated to applicable standards the proposed device will enhance the development of quality audiology applications for use with smartphones tablets and the Internet During Phase I we demonstrated the feasibility of our innovation by building a benchtop prototype of the device and testing its performance using standard clinical protocols We showed that DPOAEs measured with our prototype were equivalent to DPOAEs measured with a commercial device on a pilot human study that included subjects During Phase II we will refine the design of our device build several integrated prototypes and demonstrate their use and performance with several human subject studies in target locations and populations The Phase II human study will have two objectives compare the test results and test retest variability using the new device to what can be achieved with existing commercial devices and evaluate the performance of our device in the target populations to demonstrate its ability to increase access to hearing health in underserved populations The Creare team is extremely well qualified to successfully develop and commercialize this low cost hearing screening device for automated and remote applications Our system is made possible by leveraging hardware and software that Creare has previously developed for hearing assessment in varied settings including remote assessment in developing countries Otoacoustic Emission OAE measurement in noisy environments and advanced hearing protection PUBLIC HEALTH RELEVANCE Hearing loss is a leading public health concern with about of American adults reporting some degree of hearing loss yet fewer than of them seek help for their condition During the proposed effort we will develop innovative technology that will enable new hearing assessment paradigms to reach underserved communities expand hearing screening to a wide array of accessible locations and lower the cost of hearing screening