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

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 see RFA DC Solutions requested include enabling currently available commodities telephone Internet and smartphones to conduct surveillance of hearing loss Internet screening systems and automated audiometry to be used beyond traditional clinical and research environments One key challenge to implementing these solutions is the need to generate calibrated tones and to ensure a low noise environment Creare proposes to complete development of a hearing threshold screening device that performs automated audiometry and is controlled through a mobile platform Our device is designed for use at point of care POC locations with very limited personnel and testing facility resources it can also be used for self assessment Background noise attenuation is provided with innovative integrated high quality noise attenuating ear cups The resulting device will provide a solution to the problem of hearing healthcare access by allowing quality screening at POC locations in community centers pharmacies and big box stores which are now making low cost hearing aids 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 audiometry We showed that thresholds measured with our prototype were equivalent to thresholds measured with a commercial audiometer 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 devices and compare the performance of our device in a representative noisy environment such as POC locations to its performance in a quiet sound booth The Creare team is extremely well qualified to successfully develop and commercialize this 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 tests