According to a recent study on health disparities and hearing loss, American Indians and Alaska Natives (AIAN) have the highest rate of hearing difficulty across all the race/ethnicity groups studied. A significant portion of the hearing loss among AIAN is conductive in nature in part due to the disproportionate prevalence of otitis media in this population. Unfortunately, for many in these communities, access to hearing healthcare is difficult because they often live in very remote areas. The difficulty stems from the fact that diagnostic hearing tests currently require a sound booth to reduce ambient noise. Due to their cost and size, sound booths are typically fixed installations and patients must travel far to reach facilities with this equipment. Thus, access to hearing healthcare in remote and rural areas is a known health disparity. This 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 untreated. To address this public health issue, Creare proposes to develop a Mobile Audiometric Diagnostic System that will enable both air- and bone-conduction diagnostic hearing tests outside the sound booth, making timely hearing healthcare accessible to communities that live in remote areas where audiologists are available through telehealth. The device we propose provides ambient noise attenuation through a specially designed headset and integrates the audiometer, headphones and bone vibrators into one, easy-to-use device. Automated algorithms further enhance the system by allowing basic diagnostic assessment to be performed by a health technician/aide or nurse. Integration of our system with existing telehealth systems allows audiologists to review and, if needed, control the hearing tests remotely for full diagnostic capability. During Phase I, we will demonstrate the feasibility of our innovation by building a prototype and testing its performance against standard clinical audiology practice. 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 Creare team is extremely well qualified to successfully develop and commercialize this Mobile Audiometric Diagnostic System. Our 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 healthcare, in particular with rural and AIAN populations.

Public Health Relevance

Hearing loss is a leading public health concern, with about 17% of American adults reporting some degree of hearing loss, and the likelihood of having hearing loss in American Indian or Alaska Native (AIAN) peoples is two to four times higher than in other American subpopulations. Access to hearing healthcare is particularly difficult for people living in remote and rural areas, further compounding the impact of hearing diseases on AIAN populations. During the proposed effort, we 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 locations, and lower the cost of hearing healthcare.

Agency
National Institute of Health (NIH)
Institute
National Institute on Deafness and Other Communication Disorders (NIDCD)
Type
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
Project #
1R43DC017930-01
Application #
9776003
Study Section
Special Emphasis Panel (ZRG1)
Program Officer
Miller, Roger
Project Start
2019-09-01
Project End
2020-08-31
Budget Start
2019-09-01
Budget End
2020-08-31
Support Year
1
Fiscal Year
2019
Total Cost
Indirect Cost
Name
Creare, LLC
Department
Type
DUNS #
072021041
City
Hanover
State
NH
Country
United States
Zip Code
03755