Assessment of e-Audiology for Providing Clinical Services and Support for Age-related Hearing Loss: A Pilot Study
Phase: NA
Conditions: Hearing Loss, Age-Related, Presbycusis, Bilateral, Hearing Disability
Sponsor: University of South Florida

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Protocol 00041124: Assessment of e-Audiology for providing clinical services and support 
Background and Rationale 
Hearing loss is a chronic disability and a major public health concern. As the U.S. population ages, hearing 
loss prevalence rates are expected to nearly double by 2060 (Goman, Reed et al. 2017). Given this 
projection and the negative, costly impacts of untreated hearing loss on health outcomes, there is a 
national emphasis on increasing access and affordability of hearing healthcare (HHC) (President's Council 
of Advisors on Science and Technology 2015, National Academies of Sciences 2016). Two significant 
factors hinder the achievement of successful HHC outcomes: First, US adults face structural barriers to 
accessing HHC including high cost, and limited, inflexible points of entry into the system (National 
Academies of Sciences 2016). Second, hearing aids are often the sole intervention offered. While hearing 
aids improve speech understanding in quiet, difficulties understanding speech in challenging listening 
environments remain. Many of these difficulties can be addressed by including hearing assistive 
technology [HAT] options in the intervention plan. Unfortunately, hearing aid uptake is low for adults with 
hearing loss, and HAT usage is reported among only a fraction of those who use hearing aids (Southall, 
Gagné et al. 2009, Hartley, Rochtchina et al. 2010, Chien and Lin 2012, Bainbridge and Ramachandran 
2014). Technological advances in hearing aids and telecommunications, including the widespread 
availability of “e-Audiology” applications, have the potential to expand both access and affordability of 
HHC by allowing for greater flexibility, lower costs, and personalized intervention plans that take into 
account the listening and lifestyle needs of the individual. There is a lack of evidence, however, as to how 
e-Audiology and patient acceptance for e-Audiology impact HHC outcomes. There is an urgent need to 
understand the efficacy of accessible, patient-centered, and comprehensive HHC alternative delivery 
models, like e-Audiology, without which the critical public health problem of untreated hearing loss in 
adults will likely worsen.   
With the long-term goal of enhancing decision-making by patients and providers and improving outcomes, 
the pilot data collected in this proposal will be used for an upcoming R01 submission which will be 
responsive to the NIDCD's call for research comparing different HHC delivery models and the utilization 
of new technologies to improve care. The overall objectives of this work are twofold. First, we will evaluate 
outcomes from an e-Audiology service delivery model. Second, we will determine the impact of patient 
preferences for delivery model on outcomes. The rationale of the proposed study is that the results will 
enhance the evidence-base for the use of e-Audiology as a mechanism for increasing HHC access for 
diverse adult populations. Results obtained will be submitted as pilot data in an upcoming R01 grant 
application 
Research Objectives, Questions, and Hypotheses 
The primary research questions, objectives, and associated hypotheses of this research are as follows: 
• 
Research Question: For older adults who receive hearing aid services via an e-Audiology delivery 
model, what are the hearing-related outcomes in terms of real ear aided responses, speech 
understanding in noise, average hours of daily use, and self-perceived hearing handicap? 
Objective #1.  Assess outcomes for adults who receive hearing aid related services and support 
via an e-Audiology delivery model. The working hypothesis is that both subjective self-report and 
objective outcomes will be similar to published norms. 

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• 
Research Question: What are the preferences for audiology service delivery among older adults 
and what is the patient’s satisfaction with an e-Audiology model for hearing aid-related services? 
Objective #2. Assess patient satisfaction and preferences related to e-Audiology service delivery. 
The working hypothesis is that preference will impact outcomes, with those who prefer an e-
Audiology model having better outcomes than those who prefer an in-office model.   
Study Design 
This study is designed as a pilot. We plan to use a quasi-experimental, single-group, pre/post design to 
assess outcomes before the initial hearing aid fitting and after the 6-week study period.  
Sample size 
The anticipated number of older adults evaluated for participation in the study is 20 with the goal of 10 
participants completing the study.  It is anticipated that some participants who are enrolled will not meet 
the audiometric inclusion criteria.  
Study Population  
Inclusion criteria are as follows: 
• 
Aged 70 years or older 
• 
Community-dwelling  
• 
Can speak and read English fluently, assessed by self-report 
• 
Mild to severe sloping hearing loss, as determined by a 4-frequency pure-tone average (0.5 to 4.0 
kHz) of > 30 dB HL in the better ear and no greater than 90 dB at any frequency 
• 
Cognitively intact, as determined by a Mini-Mental State Exam (MMSE) score ≥ 23 for individuals 
with high-school degree or less; Mini-Mental State Exam (MMSE) score ≥ 25 for individuals with 
some college or more 
• 
Regular access to computer, tablet, or “smart device” capable of delivering the e-Audiology 
platform (Phonak’s Remote Support) 
Exclusion criteria are as follows: 
• 
Bilateral conductive hearing loss, defined as a > 10 dB air-bone gap at 2 or more frequencies 
• 
Corrected vision no worse than 20/40, assessed by the MN Read Acuity vision screening card 
• 
Unwillingness to use hearing aids on a daily basis, determined by self-report 
The Expected Results of the Research 
The results of this research will be submitted as pilot data in an upcoming R01 grant application.  
Principle Investigator 
The PI of this pilot study is: 
Michelle Arnold, AuD, PhD, CCC-A 
Assistant Professor 
College of Science & Mathematics, Department of Communication Sciences & Disorders 
mlarnold@usf.edu 

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Phone: 941-359-4283 
 
Potential Risks to the Participants 
Potential risks to participants in this study are minimal.  There is a slight risk of boredom, anxiety, or 
fatigue associated with complete the questionnaires, hearing testing, hearing aid fitting, and/or follow-up 
hearing aid e-Audiology sessions.  These risks will be offset by offering breaks between tasks as needed.  
All of the test measures in this study are used routinely in clinical practice by audiologists and 
psychologists for assessing the hearing and cognitive status of clinical and research participants. 
Sounds presented to participants are not harmful and are used routinely in clinical evaluations.  The 
hearing aid device evaluation and fitting procedures are standard protocols used routinely by the staff 
research audiologists.  All hearing evaluations involve an otoscopic examination which involves the use of 
an otoscope (i.e., ear flash light) with a disposable speculum that is inserted partially into the ear canal 
for visual inspection.  All hearing aids will be behind-the-ear models fitted with small, non-custom plastic 
tips that are inserted into the ear canal while the device is being worn.  The hearing aids are digital devices 
that will be programmed to the audibility needs of each participant, according to standard clinical practice 
procedures. 
Study Procedures 
• 
Measures 
o Mini Mental State Exam (MMSE) : The MMSE is a brief cognitive screening tool that will 
be used to determine whether participants are cognitively-intact according to the 
inclusion criteria. 
o Vision assessment. The University of Minnesota Read Acuity (MN Read) Card will be 
used to assess visual acuity in conditions of high contrast and luminance. The MN Read 
will be used to determine whether participants meet inclusion criteria for corrected 
vision.  
o Demographic Characteristics: A simple questionnaire will be used to obtain participants’ 
demographic information  
o Degree of hearing impairment. All participants will undergo an audiometric evaluation 
consisting of measurement of pure tone sensitivity using American Speech-Language-
Hearing Association (2018) guidelines. Understanding of speech in noise will also be 
assessed using the Quick Speech in Noise (QuickSIN; Killion, Niquette et al. (2003) in 
which participants repeat sentences presented at six signal-to-noise ratios (SNRs) and 
the ‘SNR loss’ is computed. The SNR loss is the dB SNR relative to the SNR required for 
normal hearing individuals to repeat back 50% of the key words correctly.  
o Self-reported hearing difficulties. The Hearing Handicap Inventory for the Elderly 
Screening (HHIE-S) (Ventry and Weinstein 1982, Newman and Weinstein 1988) will be 
used to measure self-reported hearing difficulties.   
o International Outcome Inventory for Hearing Aids and Other Interventions (ioi-HA). The 
IOI-HA is a brief, 7-item measure that will be used to measure hearing aid benefits 
following a sustained period of use (6 weeks or more). 

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o Real-ear acoustic responses (REAR) of hearing aid performance: REARs will be measured 
using the AudioScan Verifit II hearing aid analyzer to determine how close responses are 
to NAL-NL2 prescriptive targets 
o Telehealth Acceptance Questionnaire (TAQ). (Wade, Cartwright et al. 2012). The TAQ is 
based on the Technology Acceptance Model, and will be used to assess participants’ 
attitudes about telehealth as well as their beliefs regarding self-efficacy for telehealth 
use.  
o Client-oriented Scale of Improvement (COSI) (Dillon, James et al. 1997) – The COSI is a 
self-report tool used to determine effectiveness of hearing aid intervention based on 
the user’s own goals.  
o Average hourly hearing aid and HAT use: Annual device usage will be tracked using the 
hearing device data logging software.  
o Patient satisfaction with service delivery: Patient satisfaction with service delivery will be 
assessed after each e-Audiology session using the Visit Specific Satisfaction Instrument 
(VSQ-9) (Association AMG).  
o Semi-structured interview. Participants will take part in a semi-structured interview at the 
end of the study. We will be asking questions regarding: (1) the participant’s perceptions 
regarding e-Audiology services (2) Preferences for in-office vs. telehealth appointments 
in general  
• 
Intervention. Participants will receive bilateral, behind-the-ear hearing aids as part of this study. 
The intervention will involve e-Audiology sessions following the initial hearing aid fitting and 
orientation. E-Audiology sessions will consist of hearing aid follow-up programming, 
troubleshooting, HAT assistance, and general help with hearing devices. E-Audiology sessions will 
take place over the course of approximately 6 weeks.  
• 
Study Visits 
o Baseline visit: At the time of the baseline visit, participants will undergo the informed 
consent process and complete measures to determine whether they meet inclusion 
criteria (MoCA, SKILL, unaided HHIE-S, Audiometric assessment, demographic intake). For 
those who continue onto enrollment, the next step will be to complete hearing aid fitting,  
device orientation and use counseling, and completion of the COSI.  
o Follow-Up visits (e-Audiology sessions): Follow-up visits will take place at regularly-
scheduled, 2-week intervals following the baseline visit over the course of 6 weeks, or as 
needed by the participant. E-Audiology sessions will consist of hearing aid follow-up 
programming, troubleshooting, and general help with hearing devices. Data logging and 
VSQ-9 data will be collected after each e-Audiology session.  
o Outcomes assessment visit: Participants will return to the laboratory setting to complete 
the outcomes assessment visit approximately 6 weeks following the baseline visit. 
Outcomes assessments will include: REARs, average hourly hearing aid use, aided 
QuickSIN testing, COSI outcomes, aided HHIE-S outcomes, and the semi-structured exit 
interview.  
• 
Data Analysis. As this is a pilot study, the majority of results will be analyzed descriptively. When 
possible, non-parametric analyses will be conducted to determine differences pre/post baseline 
hearing aid fitting for the HHIE-S, QuickSIN, and COSI.  
Potential Benefits to Participants 

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The protocol offers several benefits to participants, including a comprehensive audiometric evaluation, 
state-of-the-art hearing technology, and communication strategies training free of charge. Participants 
will be informed of the results of evaluations and will have the opportunity to ask questions about those 
results.  Participants will be referred to other professionals for additional evaluation or treatment as 
necessary.  Ultimately, this study may also benefit the public at large by helping to determine efficient 
delivery of hearing rehabilitative intervention that leads to improved communication abilities for hearing-
impaired older adults. 
Human Subjects Considerations 
• 
Informed Consent Process: Written consent will be obtained from all participants.  Participants 
who express an interest in participating will be provided a copy of the consent form prior to the 
first visit, either by U.S. mail or in person, and instructed to carefully review the consent form 
before the study visit. Upon arrival at the study visit, the investigator will describe the purpose of 
the informed consent and will ask if there are any questions about informed consent. The 
investigator will then briefly review information contained in the informed consent form and the 
voluntary nature of participation will be explained and emphasized. The investigator will ask the 
potential participant several questions such as naming potential risks of participating in the study, 
the number of visits in the study, and what the patient should do if they experience any problems 
during the study. The participant must be alert, able to communicate, able to understand 
information about the research, make a decision based upon the information, and give informed 
consent. If there is any indication that the participant does not comprehend the consent 
information following any clarification that has been made, participation will not be allowed.  
Following review, the investigator will ask if there are any other questions and will allow the 
subject to sign the informed consent if they so choose. No participants considered to be 
Vulnerable Subjects will be enrolled. 
• 
Privacy and confidentiality: All participants will have a participant number assigned at the time of 
their initial laboratory participation.  All data for each participant will be coded with this number.  
Patient intake forms with PHI will be stored separately from the participant files with the signed 
informed consent documents. Any original results in paper form will be stored in a file folder 
marked with the subject participation number on the outside.  All data will be stored within that 
folder, including the results from the audiometric evaluation and score sheets from speech and 
non-speech auditory perceptual tasks.  Subject folders will be stored in a locked file cabinet in the 
laboratory, PCD 1003, 4202 E. Fowler Ave., University of South Florida.  Access to the data will be 
restricted to laboratory staff approved by this IRB.  All electronic data will be stored on a secure 
server at USF.  The research team will make every effort to protect participant information and 
guard against any loss of privacy. 
o COVID-19 contingency plan: Participants with remaining remote sessions scheduled will 
be seen using the same telehealth technology. An ARCT lab member who is IRB approved 
will conduct these sessions using a USF laptop in a private room of their own home. 
Participants will be notified of these changes via written correspondence (can be seen in 
“Other Site Documents” section of the IRB application), and will be allowed to suspend 
their final remote visit until the risk of COVID-19 is significantly reduced. In the event a 
participant opts to suspend their final visit, an RNI Smartform for protocol deviation will 
be submitted to the IRB within 5 business days of the event.  
 

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References 
American Speech-Language-Hearing Association (2018). "Scope of practice in audiology." Retrieved 
4/1/2019, 2019, from https://www.asha.org/policy/sp2018-00353/. 
 
 
Association AMG. "Vist-Specific Satisfaction Questionnaire (VSQ-9)." Retrieved 05/15/2019, from 
http://www.rand.org/health /surveys_tools/vsq9.html. 
 
 
Bainbridge, K. E. and V. Ramachandran (2014). "Hearing aid use among older U.S. adults: The National 
Health and Nutrition Examination Survey, 2005-2006 and 2009-2010." Ear and Hearing 35(3): 289-294. 
 
 
Chien, W. and F. R. Lin (2012). "Prevalence of hearing aid use among older adults in the United States." 
Archives of Internal Medicine (Chicago, Ill.: 1908) 172(3): 292-293. 
 
 
Dillon, H., et al. (1997). "Client Oriented Scale of Improvement (COSI) and its relationship to several 
other measures of benefit and satisfaction provided by hearing aids." Journal of the American Academy 
of Audiology 8(27-43). 
 
 
Goman, A. M., et al. (2017). "Addressing estimated hearing loss in adults in 2060." JAMA Otolaryngology 
- Head & Neck Surgery published online March 2, 2017. 
 
 
Hartley, D., et al. (2010). "Use of hearing aids and assistive listening devices in an older Australian 
population." Journal of the American Academy of Audiology 21: 642-653. 
 
 
Killion, M. C., et al. (2003). "Development of a quick speech-in-noise test for measuring signal-to-noise 
ratio loss in normal-hearing and hearing-impaired listeners." Journal of the Acoustical Society of America 
116(4): 2395-2405. 
 
 
National Academies of Sciences, E., and Medicine, (2016). Hearing health care for adults: Priorities for 
improving access and affordability. Washington, DC: The National Academies Press. 
 
 
Newman, C. W. and B. E. Weinstein (1988). "The Hearing Handicap Inventory for the Elderly as a 
measure of hearing aid benefit." Ear and Hearing 9(2): 81-85. 
 
Hearing impairment in older adults is associated with psychological and social difficulties. The 
goal of hearing aid fitting is to reduce the perceived handicap resulting from the hearing loss. 
Measures of self-perceived handicap are being increasingly incorporated into the clinicians 
armamentarium as an objective measure of the outcome of intervention. Eighteen elderly 
hearing-impaired males and their spouses responded to the Hearing Handicap Inventory for the 
Elderly (HHIE) prior to and following 1 year of hearing aid provision. Our findings revealed a 
significant reduction in the perceived emotional and social effects of hearing impairment 
following 1 year of hearing aid use. The reduction in perceived handicap, as measured using the 

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HHIE, was greater for the hearing aid users than for their spouses. The findings attest to the 
construct validity of the HHIE as a measure of hearing aid benefit. 
 
President's Council of Advisors on Science and Technology (2015). Aging America & Hearing Loss: 
Imperative of Improved Hearing Technologies. 
 
 
Southall, K., et al. (2009). "Factors that influence the use of assistance technologies by older adults who 
have a hearing loss." International Journal of Audiology 45(4): 252-259. 
 
 
Ventry, I. M. and B. E. Weinstein (1982). "The Hearing Handicap Inventory for the Elderly: A new tool." 
Ear and Hearing 3(3): 128-134. 
 
 
Wade, R., et al. (2012). "Factors relating top home telehealth acceptance and usage compliance." Risk 
Management and Healthcare Policy 5: 25-33.