The NIDCD and NIA have strongly encouraged research leading to ?accessible and affordable hearing health care and improved outcomes? through new delivery systems in clinical settings. This is an especially significant problem for the rapidly growing 65+ population. Older adults are more prone to suboptimal hearing aid use and care because of their special learning needs, combined with insufficient time available for audiologists? ?after care? and the demonstrated inadequacy of hearing aid manufacturers? instruction manuals. We have hypothesized that effective hearing aid education/training reinforcement and follow-up care via new, personalized, easy-to-use technology will ensure more successful outcomes. In Phase I, in response to this public health need, Healthcare Technologies and Methods (HTM) developed and pilot-tested a novel prototype product we named TELLYHealthTM. This innovative, personalized, patient- centered product engaged older patients with hearing loss and ?connected them? with their audiologist. The 6-week pilot tests demonstrated the feasibility of TELLYHealthTM. On a 5-point Likert scale, subjects rated TELLYHealth?s ease of use 4.75 and their hearing aid satisfaction 4.42. The Abbreviated Profile of Hearing Aid Benefit (APHAB) and the Hearing Handicap Inventory for the Elderly (HHIE) revealed a significantly improved hearing aid benefit and a reduced hearing handicap, respectively. In Phase II, HTM converted the prototype into a more cost-effective and scalable app-based TELLYHealthTM system that provided the additional functionality and educational content requested by patients and audiologists in Phase I. HTM also conducted a randomized controlled trial (RCT) at two audiology practices that generated equally encouraging usability data along with efficacy data and valuable qualitative feedback. In this CRP grant, HTM proposes to leverage marketing, intellectual property, financing and software technical support to incorporate lessons learned from Phase II (feedback from audiologists and their patients) and to prepare the product for successful commercialization. Our goal is to form a strategic alliance with a well- established healthcare company that will include financing.

Public Health Relevance

Inadequate patient education, training and follow-up by time-strapped audiologists contribute to patient dissatisfaction with hearing aids, often leading to hearing aids being used very infrequently, returned or relegated to a drawer. Because untreated hearing loss results in a 200- 300% increase in the risk of dementia, depression, and falls, it is imperative that older adults with hearing deficits be screened and fitted with hearing aids and use them effectively. We have developed a novel, cost-effective, interactive app-based product specially designed for ease of use and acceptance by older adults called TELLYHealthTM that reinforces patient self-efficacy and knowledge while transmitting valuable patient feedback to the audiologist ? and we propose this CRP grant to provide the formula for successful commercialization: software enhancements derived from our Phase II research and strategies to achieve the company?s intellectual property, marketing and partnering/financing initiatives.

Agency
National Institute of Health (NIH)
Institute
National Institute on Aging (NIA)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
2R44AG045947-04A1
Application #
10157568
Study Section
Special Emphasis Panel (ZRG1)
Program Officer
St Hillaire-Clarke, Coryse
Project Start
2013-09-30
Project End
2022-12-31
Budget Start
2021-01-15
Budget End
2021-12-31
Support Year
4
Fiscal Year
2021
Total Cost
Indirect Cost
Name
Healthcare Technologies and Methods
Department
Type
DUNS #
828763073
City
Fredericksburg
State
VA
Country
United States
Zip Code
22407