Hearing Loss, Age-RelatedeAudiologyNCT04048460
Assessment of e-Audiology for Providing Clinical Services and Support
A study testing Delivery of hearing healthcare through eAudiology application in people with Hearing Loss, Age-Related and Presbycusis, Bilateral, run by University of South Florida at 1 site in United States.
Trial summary
Technological advances in hearing aids and telecommunications, including the widespread availability of telehealth (referred to in this proposal as "e-Audiology") applications, have the potential to expand both access and affordability of hearing aids for those with age-related hearing loss (ARHL). Read more about this study
- Who is it for?
- Ages 70 to 89 years
- Conditions the study is for
- Hearing Loss, Age-Related, Presbycusis, Bilateral, Hearing Disability
- What is being tested?
- Delivery of hearing healthcare through eAudiology application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2019to 15 Apr 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 to 89 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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 of 23 or greater
- Regular access to computer, tablet, or "smart device" capable of delivering the e-Audiology platform
Who cannot join
- Bilateral conductive hearing loss, defined as a > 10 dB air-bone gap at 2 or more frequencies
- Corrected vision no worse than 20/63, assessed by the MN Read Acuity vision screening
- Unwillingness to use hearing aids on a daily basis, determined by self-report
Trial locations and contacts
1 site in 1 country.
United States1 site
Auditory Rehabilitation and Clinical Trials Laboratory at the University of South Florida
Tampa, Florida, 33620
About this study
Official title: Assessment of e-Audiology for Providing Clinical Services and Support for Age-related Hearing Loss: A Pilot Study
Technological advances in hearing aids and telecommunications, including the widespread availability of telehealth (referred to in this proposal as "e-Audiology") applications, have the potential to expand both access and affordability of hearing aids for those with age-related hearing loss (ARHL). E-Audiology is used by clinicians in a variety of settings, including private practice, university clinics, and the Veterans Administration. The American Speech-Language-Hearing Association recently updated the Scope of Practice guidelines for audiology to include telehealth as "an alternative method of service delivery that en-compasses both diagnostics and intervention services.", including all aspects of hearing aid selection, fitting, and follow-up counseling and rehabilitation. However, given the paucity of evidence of comparative efficacy between office-based service delivery and e-Audiology in real-world settings, patients and relevant stakeholders are faced with a major decisional dilemma when determining which mode of service delivery would be optimal for addressing the needs, preferences, and lifestyles of those with ARHL. Thus, the purpose of this study is to determine the benefits, drawbacks, and patient satisfaction associated with e-Audiology delivery of hearing aid fitting, services, and supports for older adults with mild to moderate ARHL. We plan to use data collected in this pilot study for a future R01 submission to the NIH.
Read the detailed description
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.
- Being tested
- Delivery of hearing healthcare through eAudiology application
- Keywords
- telehealth, eAudiology, accessibility, Age-related hearing loss
- Medical subject headings
- Presbycusis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delivery of hearing healthcare through eAudiology applicationDevice
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 group | Role | What they receive |
|---|---|---|
| eAudiology | Experimental | 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. Receives: Device: Delivery of hearing healthcare through eAudiology application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline on the Hearing Handicap Inventory for the Elderly Screening Version (HHIE-S)
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.
The Hearing Handicap Inventory scale is reported as an average across all participants and has a minimum value of 0 and a maximum value of 40. Higher scores indicate more perceived social and emotional difficulty due to an individuals hearing loss.
Change in HHIE scores were calculated based on the change from baseline to 6 weeks-post intervention.
Measured: 6 weeks post-intervention
Secondary outcomes (3)
Change From Baseline on the Quick Speech-in-Noise (QuickSIN) Test
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.
Higher scores on the signal to noise ratio loss scale indicates more difficulty with hearing speech-in-noise compared to normal hearing peers. The range of performance is from 2-dB SNR to 24-dB SNR. Scores are reported as the average SNR loss across all participants. The change in SNR loss was calculated based on the change in average score from baseline to 6-weeks post-intervention.
Measured: 6 weeks post-intervention
Change From Baseline on the Telehealth Acceptance Questionnaire (TAQ)
Telehealth Acceptance Questionnaire (TAQ; Wade, 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. The TAQ uses a visual analog scale and the units range from 0 mm (lowest acceptance of telehealth) to 100 mm (higher acceptance of telehealth). The scores are reported as an average across all participants. Change from baseline was calculated based on the change in average score from baseline to 6-weeks post-intervention.
Measured: 6 weeks post-intervention
International Outcome Inventory for Hearing Aids (IOI-HA)
The IOI-HA will be used to determine specific hearing aid benefits perceived by the participants following a sustained period of use. This a post-intervention measurement only as questions are specific to the intervention adopted.
The International Outcome Inventory scale ranges from 7 to 35. A higher score would indicate more perceived benefit from hearing aids.
Measured: 6 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2019
- Study start15 Aug 2019
- Primary completion15 Apr 2020
- Study completion15 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hearing Loss, Age-RelatedStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Victoria Sanchez (Williams), University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04048460
- Sponsor's protocol ID
- Pro00041124
- Acronym
- eAudiology
- Status last verified
- Feb 2021
- First submitted
- 5 Aug 2019
- Last updated
- 4 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of e-Audiology for Providing Clinical Services and Support for Age-related Hearing Loss: A Pilot Study
- ClinicalTrials.gov ID
- NCT04048460
- Acronym / sponsor ID
- eAudiology / Pro00041124
- Keywords
- telehealth, eAudiology, accessibility, Age-related hearing loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- 15 Aug 2019 (actual)
- Primary completion
- 15 Apr 2020 (actual)
- Study completion
- 15 Apr 2020 (actual)
- First posted
- 7 Aug 2019 (actual)
- Results
- Posted 4 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Technological advances in hearing aids and telecommunications, including the widespread availability of telehealth (referred to in this proposal as "e-Audiology") applications, have the potential to expand both access and affordability of hearing aids for those with age-related hearing loss (ARHL). E-Audiology is used by clinicians in a variety of settings, including private practice, university clinics, and the Veterans Administration. The American Speech-Language-Hearing Association recently updated the Scope of Practice guidelines for audiology to include telehealth as "an alternative method of service delivery that en-compasses both diagnostics and intervention services.", including all aspects of hearing aid selection, fitting, and follow-up counseling and rehabilitation. However, given the paucity of evidence of comparative efficacy between office-based service delivery and e-Audiology in real-world settings, patients and relevant stakeholders are faced with a major decisional dilemma when determining which mode of service delivery would be optimal for addressing the needs, preferences, and lifestyles of those with ARHL. Thus, the purpose of this study is to determine the benefits, drawbacks, and patient satisfaction associated with e-Audiology delivery of hearing aid fitting, services, and supports for older adults with mild to moderate ARHL. We plan to use data collected in this pilot study for a future R01 submission to the NIH.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| eAudiology | Experimental | Device: Delivery of hearing healthcare through eAudiology applicationParticipants 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. |
Who may qualify
- Ages
- 70 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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 of 23 or greater
Key exclusion criteria (3 listed)
- Bilateral conductive hearing loss, defined as a > 10 dB air-bone gap at 2 or more frequencies
- Corrected vision no worse than 20/63, assessed by the MN Read Acuity vision screening
- Unwillingness to use hearing aids on a daily basis, determined by self-report
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Delivery of hearing healthcare through eAudiology applicationParticipants 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. | Device | eAudiology |
Primary outcome
Change From Baseline on the Hearing Handicap Inventory for the Elderly Screening Version (HHIE-S)
Time frame: 6 weeks post-intervention
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. The Hearing Handicap Inventory scale is reported as an average across all participants and has a minimum value of 0 and a maximum value of 40. Higher scores indicate more perceived social and emotional difficulty due to an individuals hearing loss. Change in HHIE scores were calculated based on the change from baseline to 6 weeks-post intervention.
3 secondary outcomes
Change From Baseline on the Quick Speech-in-Noise (QuickSIN) Test
Time frame: 6 weeks post-intervention
Change From Baseline on the Telehealth Acceptance Questionnaire (TAQ)
Time frame: 6 weeks post-intervention
International Outcome Inventory for Hearing Aids (IOI-HA)
Time frame: 6 weeks post-intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Delivery of hearing healthcare through eAudiology application in people with Hearing Loss, Age-Related and Presbycusis, Bilateral, run by University of South Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline on the Hearing Handicap Inventory for the Elderly Screening Version (HHIE-S) (time frame: 6 weeks post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2021; AzTrials last refreshed its copy on 7 Nov 2026.