SBIR-STTR Award

An Innovative Person-Centered Hearing Aid Education and Aural Rehab System
Award last edited on: 5/23/2022

Sponsored Program
SBIR
Awarding Agency
NIH : NIA
Total Award Amount
$3,932,751
Award Phase
2
Solicitation Topic Code
866
Principal Investigator
Alan M Letzt

Company Information

Healthcare Technologies and Methods LLC (AKA: HTM)

20209 Creekspring Court
Purcellville, VA 20132
   (540) 751-1100
   aletzt@earthlink.net
   www.healthcaretm.com
Location: Single
Congr. District: 10
County: Loudoun

Phase I

Contract Number: 1R43AG045947-01A1
Start Date: 9/30/2013    Completed: 8/31/2014
Phase I year
2013
Phase I Amount
$223,897
More than 20 million elderly people in the US have significant hearing loss but only 20% use hearing aids. Of these, 35 - 50% are dissatisfied with them, which often results in the hearing aids being returned within the trial period or left "in-the-drawer". With untreated hearing loss resulting in a 200% - 300% increase in the risk of dementia, depression, and falls, and severe communication difficulties with family members and friends, it is imperative that older adults are not only screened for hearing loss and, when appropriate, fit with hearing aids, but that steps are taken to ensure patients' acceptance and proper use of, and continued satisfaction with the hearing aids. Alternative approaches for patient education and training have included DVDs (which are neither individualized nor interactive and have met with limited success), and the Internet, which is used by only 35% of people over age 65. This Phase I SBIR study will focus on older people with hearing loss who are not technology-savvy. We propose an innovative, interactive patient-centered product that builds on the home TV - which people age 65 and older watch an average of 49 hrs/week. By simply using a TV remote control, patients will view short educational videos on demand and avail themselves of other innovative and beneficial patient-centered features that are very easy to use. In addition, the audiologist will receive data on the patients' learning and behavioral experiences to further individualize aftercare. This interactive TV approach is consistent with vision articulated by Apple Computer founder Steve Jobs, who said shortly before his untimely death, "I'd like to create an integrated television set that is completely easy to use". Our hypothesis is that the interactive TV system and content developed in this project will appeal to the targeted subgroup of patients age 60 and older, resulting in improved use of and satisfaction with their hearing aids. We also believe it will appeal to the audiologist who will use his/her time more effectively. The Phase I study will develop the interactive TV technology and comprehensible hearing aid education and training videos, and then conduct a pilot test with 30 subjects. The aims of the pilot test are to demonstrate patients' and audiologists' ease of use and satisfaction with the new system as well as improved hearing experiences as measured by two standardized instruments: the APHAB and the COSI. In Phase II, HTM will improve the product design, develop additional content based on the lessons from Phase I, and then conduct a randomized controlled trial to quantify the benefits to patients, family members, audiologists, and manufacturers. Following Phase II, HTM's sales team plans to sell or license this interactive system to retail hearing centers nationwide.

Public Health Relevance Statement:


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 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 that steps are taken to ensure hearing aid acceptance, continued satisfaction, and proper use. Consequently, we propose development and testing of a new, low-cost, easy-to-use product specially designed for use and acceptance by older people who are averse to the Internet: an interactive television-based system that provides patients with instructional videos on hearing aid use and maintenance, while sending valuable patient feedback to their audiologists.

NIH Spending Category:
Aging; Assistive Technology; Behavioral and Social Science; Bioengineering; Brain Disorders; Clinical Research; Clinical Trials; Prevention; Rehabilitation

Project Terms:
Address; Aftercare; Age; Age Factors; American; Apple; base; Behavioral; Boxing; Cessation of life; Client satisfaction; commercialization; Communication; Computers; coping; cost; Data; Dementia; design; Development; Educational aspects; Elderly; Ensure; expectation; experience; fall risk; falls; Family member; Feedback; follow-up; Friends; health literacy; Hearing; Hearing Aids; hearing impairment; Home environment; Hour; Human; Human Resources; improved; Incidence; Individual; innovation; instrument; Internet; Jupiter; Learning; Left; Licensing; Link; Maintenance; Manufacturer Name; Measures; meetings; Mental Depression; Names; National Institute on Deafness and Other Communication Disorders; novel; Occupations; older patient; operation; Outcome; Patient Education; patient oriented; Patient Self-Report; Patients; Phase; phase 1 study; phase 2 study; Process; public health relevance; Quality of life; Questionnaires; Randomized Controlled Trials; Reporting; Risk; Sales; satisfaction; Secure; Self Efficacy; Small Business Innovation Research Grant; Stuttering; Subgroup; success; System; Technology; Television; Testing; Time; Training; Training and Education; Transportation; Vision; Visit; web site; Wireless Technology

Phase II

Contract Number: 2R44AG045947-02A1
Start Date: 9/30/2013    Completed: 5/31/2018
Phase II year
2016
(last award dollars: 2022)
Phase II Amount
$3,708,854

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, interactive, patient- centered product engaged older patients with hearing loss and “connected them” with their audiologist. HTM developed novel design methods and sophisticated software that integrated standard televisions with interactive voice response and Internet technologies. To meet the educational reinforcement needs of older adults, HTM creatively applied “human factors for the aging” and health literacy-appropriate content development methods. 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 will use the Phase I lessons and experiences to convert the prototype into a cost-effective, scalable TELLYHealthTM system that provides the additional functionality and educational content requested by patients and audiologists. Phase II content will include interactive lessons on real-world communications strategies to help all patients derive maximum value from their hearing aids. In addition, HTM will conduct a randomized controlled trial (RCT) to quantify the benefits of TELLYHealthTM to patients and audiologists. The RCT aims to demonstrate that subjects using TELLYHealthTM will achieve statistically significant reductions in hearing handicap, and statistically significant higher scores in hearing aid knowledge, handling, use and communications strategies than those in the control group and that the audiologist will require less time to provide aftercare to subjects in the experimental group. Following Phase II, HTM will be prepared to market, sell and support TELLYHealthTM to organizations nationwide.

Public Health Relevance Statement:
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 that steps are taken to ensure hearing aid acceptance, proper use, and continued satisfaction. Consequently, we propose a novel, cost-effective product specially designed for ease of use and acceptance by older adults called TELLYHealthTM: an interactive system that presents instructional videos on hearing aid use, maintenance, and communications strategies and other patient-centered features to reinforce patient self-efficacy and knowledge while transmitting valuable patient feedback to the audiologist.

Project Terms:
Address; Aftercare; Age; Age Factors; Agreement; American; animation; Auditory; base; Caring; Cellular Phone; Client satisfaction; Clinical; Color; commercialization; Communication; Computer software; Control Groups; cost effective; Counseling; Dementia; design; diaries; Disabled Persons; Education; Elderly; Ensure; Equipment and supply inventories; expectation; experience; fall risk; falls; Familiarity; Feedback; follow-up; handheld mobile device; handicapping condition; Health; health care delivery; health literacy; Healthcare; Hearing; Hearing Aids; hearing impairment; Home environment; Hour; Human; improved; improved outcome; Incidence; innovation; Instruction; Internet; Jupiter; Knowledge; Language; Learning; Left; Licensing; Link; Maintenance; Manuals; Manufacturer Name; Marketing; meetings; Mental Depression; method development; Methods; Modeling; Names; National Institute on Deafness and Other Communication Disorders; novel; older patient; operation; Outcome; Patient Education; patient oriented; Patients; Phase; Population; Private Sector; prototype; Psychological reinforcement; Public Health; Public Sector; Quality of life; Randomized Controlled Trials; Reporting; Research; response; Risk; Sales; satisfaction; Savings; Secure; Self Efficacy; Self Management; Site; skills; Small Business Innovation Research Grant; Social isolation; success; System; Tablet Computer; Technology; Television; Testing; Time; Touch sensation; Training; Training and Education; Transportation; Visit; Voice; web site