Hearing Loss, SensorineuralNCT06560918
Self-efficacy-based Auditory Rehabilitation With Over-the-Counter Hearing Aids
A study testing hearing aids in people with Hearing Loss, Sensorineural, run by University of Arkansas at 1 site in United States.
Trial summary
This goal of this study is to learn if a new audiology treatment process called the self-efficacy-based auditory rehabilitation (SEBAR) can improve confidence and success with over-the-counter (OTC) hearing aids. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss, Sensorineural
- What is being tested?
- hearing aids
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2024to 31 Jan 2026
- 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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Between 18 - 85 years old
- Non-fluctuating, adult-onset, bilateral mild-to-moderate sensorineural hearing loss (average hearing thresholds for 500-3000Hz between 25- and 60-dB HL and no more than 10 dB difference between ears).
- No previous experience with hearing aids
- English as their first language with good self-reported health
Who cannot join
- Any reported history of outer or middle ear pathologies • No participants will be excluded based on their gender, race/ethnicity.
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Audiology, University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72204
About this study
Official title: Self-efficacy-based Auditory Rehabilitation to Optimize Real-world Outcomes With Over-the-Counter Hearing Aids: A Pilot Study
This goal of this study is to learn if a new audiology treatment process called the self-efficacy-based auditory rehabilitation (SEBAR) can improve confidence and success with over-the-counter (OTC) hearing aids.
The main questions it aims to answer are:
Read more
- Can the SEBAR improve participants' confidence related to managing their over-the-counter hearing aids?
- Can the SEBAR improve participants' willingness to adopt over-the-counter hearing aids, their satisfaction, quality of life, and their emotional state? Researchers will compare these outcomes of the SEBAR with and without wearing OTC hearing aids.
Participants will:
- Visit for one appointment to complete a few questionnaires without OTC hearing aids
- Wear a pair of ITC hearing aids for a week and use an app to answer questions about their experiences
- Visit for a second appointment to complete the same questionnaires with OTC hearing aids.
Read the detailed description
The proposed study will use a single-arm pre-post intervention research design to achieve both the aims. Participants will complete two appointments. Assessments in the first appointment will serve as the baseline (unaided). This will be followed by a week of OTC HA use and SEBAR implementation in their natural listening situations and the outcome measures will be completed again in appointment 2 (aided) to reflect the impact of wearing OTC HAs. Scores on the outcome measures will be compared between the unaided and the aided conditions to answer both the aims. Both the appointments in the proposed study will be completed in the shared and dedicated research spaces in the Department of Audiology and Speech Pathology, College of Health Professions at the University of Arkansas for Medical Sciences. The research proposal will be submitted for the university's Institutional Review Board's approval Upon arrival participants will complete the consent process in which the PI will describe in detail all study procedures, risks and benefits of the study, and the lack of negative consequences should the participant choose to withdraw from the study or cease participation during data collection. Once the consent form has been signed, the participant will complete two appointments.
Appointment 1: For each interested participant, a standard audiometric procedure will be completed to confirm their eligibility. Once the eligible participants consent, preliminary measures will be completed. Participants will then complete the unaided baseline outcome measures of hearing aid self-efficacy, willingness to adopt HAs, expected HA satisfaction, current emotional state, and quality of life. At this time, OTC HAs will be fitted to the participants and they will receive the SEBAR. Participants will be instructed to use the HAs for at least 4 hours every day for the next week. Finally, the EMA app will be installed on their phone and its use at home will be demonstrated by the researcher.
Appointment 2: At this appointment, data from the EMA app during the one-week field trial will be stored. HAs will be tested using the Verifit 2 to verify if they are providing the required amount of amplification at the participants' preferred settings. All the outcome measures conducted will be repeated to reflect the outcomes after using the OTC HAs for a week.
- Conditions
- Hearing Loss, Sensorineural
- Being tested
- hearing aids
- Medical subject headings
- Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hearing aidsDevice
OTC devices for a week
| Study group | Role | What they receive |
|---|---|---|
| Pre-post single arm design | Experimental | Participants will wear the hearing aids for a week while receiving the SEBAR. Outcomes will be assessed with and without hearing aids. Receives: Device: hearing aids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Total Confidence
The Measure of Audiologic Rehabilitation Self-Efficacy for Hearing Aids (MARS-HA), referred to as MARSHA, is a 24-item, validated, self-report questionnaire used to assess an individual's confidence (self-efficacy) in their ability to use and manage hearing aids. Participants rated their confidence for each item (0 - 100%) and the average percentage across all items was calculated as the percentage of total confidence. Scores between pre- and post-conditions were compared and reported here.
Measured: 1 week
Secondary outcomes (4)
Total Readiness Score on the URICA Scale
Participants' readiness to adopt HAs was assessed using the 32-item modified University of Rhode Island Change Assessment (URICA). Each item presents a statement that asks about how ready a person is to move along in their hearing-health journey and adopt a treatment such as HAs. Participants respond to each item using a 5-point scale ranging from strongly disagree (1 point) to strongly agree (5 points). Items represent the stages of change (precontemplation, contemplation, preparation, action). Total readiness score (Readiness for change) is calculated by adding the scores representing the stages contemplation, preparation, action and subtracting this from scores on the items representing the precontemplation stage. The range of total readiness for change score is -2 to 14. Higher score represents higher readiness to adopt HAs, with scores of 11 or more is considered appropriate for someone to have the readiness to taken action to get hearing aids.
Measured: 1 week
Hearing Aid Satisfaction on SADL Average Score
The Satisfaction with Amplification in Daily Life (SADL) Scale is a standardized, self-report instrument used to assess patient satisfaction with hearing aid use, including perceived benefit, usability, and psychosocial impact. It has 15 items in 4 subscales (Positive Effect, Service and Cost, Negative Features, Personal Image). For this study, only average score across all items was calculated. For each item participants respond the frequency (how frequently the said outcome in the item happens with them or true for them). Average frequency score (ranging from 1-5) across all items is used for analysis. The range of possible score is 1 to 7. Higher scores indicate greater satisfaction with hearing aids (better outcome). Lower scores indicate lower satisfaction or greater perceived difficulty with hearing aids (poorer outcomes).
Measured: 1 week
Emotional State Total Score
Participants' change in emotional state will be assessed using the, 20-item, Positive and Negative Affect Schedule-Short Form (PANAS-SF). Participants respond to each item on a 5-point Likert scale ranging from "very slightly or not at all" to "extremely." Participants are asked to read each word and indicate the extent (intensity) to which they feel that way before/after wearing HAs. Positive and negative affective scores will be computed by calculating the sum of the items included for each of these two subscales. For this study, the final emotional state average score was calculated by subtracting the negative state score from the positive state score for each participant. Total possible range of scores would be -40 to +40. A positive emotional state total score indicated that the participant reported greater positive emotional states than negative emotional states.
Measured: 1 week
Hearing-related Quality of Life Total Score
A one-item hearing-related quality of life question wase used. The question asked about participants' current quality of life compared to before. The scale ranges from "a very great deal worse" (-7) to "a very great deal better" (7). An absolute change of 2 or more is considered clinically relevant in audiology. Higher positive values indicate improvements in hearing- related QOL and higher negative values indicate reduced hearing related QOL.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start30 Oct 2024
- Primary completion31 Jan 2026
- Study completion31 Jan 2026
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, SensorineuralStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe 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
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06560918
- Sponsor's protocol ID
- 297731
- Status last verified
- Jul 2026
- First submitted
- 15 Aug 2024
- Last updated
- 5 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-efficacy-based Auditory Rehabilitation to Optimize Real-world Outcomes With Over-the-Counter Hearing Aids: A Pilot Study
- ClinicalTrials.gov ID
- NCT06560918
- Acronym / sponsor ID
- 297731
- Conditions
- Hearing Loss, Sensorineural
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- 30 Oct 2024 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 31 Jan 2026 (actual)
- First posted
- 19 Aug 2024 (actual)
- Results
- Posted 5 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This goal of this study is to learn if a new audiology treatment process called the self-efficacy-based auditory rehabilitation (SEBAR) can improve confidence and success with over-the-counter (OTC) hearing aids.
The main questions it aims to answer are:
- Can the SEBAR improve participants' confidence related to managing their over-the-counter hearing aids?
- Can the SEBAR improve participants' willingness to adopt over-the-counter hearing aids, their satisfaction, quality of life, and their emotional state? Researchers will compare these outcomes of the SEBAR with and without wearing OTC hearing aids.
Participants will:
- Visit for one appointment to complete a few questionnaires without OTC hearing aids
- Wear a pair of ITC hearing aids for a week and use an app to answer questions about their experiences
- Visit for a second appointment to complete the same questionnaires with OTC hearing aids.
Detailed description
The proposed study will use a single-arm pre-post intervention research design to achieve both the aims. Participants will complete two appointments. Assessments in the first appointment will serve as the baseline (unaided). This will be followed by a week of OTC HA use and SEBAR implementation in their natural listening situations and the outcome measures will be completed again in appointment 2 (aided) to reflect the impact of wearing OTC HAs. Scores on the outcome measures will be compared between the unaided and the aided conditions to answer both the aims. Both the appointments in the proposed study will be completed in the shared and dedicated research spaces in the Department of Audiology and Speech Pathology, College of Health Professions at the University of Arkansas for Medical Sciences. The research proposal will be submitted for the university's Institutional Review Board's approval Upon arrival participants will complete the consent process in which the PI will describe in detail all study procedures, risks and benefits of the study, and the lack of negative consequences should the participant choose to withdraw from the study or cease participation during data collection. Once the consent form has been signed, the participant will complete two appointments.
Appointment 1: For each interested participant, a standard audiometric procedure will be completed to confirm their eligibility. Once the eligible participants consent, preliminary measures will be completed. Participants will then complete the unaided baseline outcome measures of hearing aid self-efficacy, willingness to adopt HAs, expected HA satisfaction, current emotional state, and quality of life. At this time, OTC HAs will be fitted to the participants and they will receive the SEBAR. Participants will be instructed to use the HAs for at least 4 hours every day for the next week. Finally, the EMA app will be installed on their phone and its use at home will be demonstrated by the researcher.
Appointment 2: At this appointment, data from the EMA app during the one-week field trial will be stored. HAs will be tested using the Verifit 2 to verify if they are providing the required amount of amplification at the participants' preferred settings. All the outcome measures conducted will be repeated to reflect the outcomes after using the OTC HAs for a week.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pre-post single arm design | Experimental | Device: hearing aidsParticipants will wear the hearing aids for a week while receiving the SEBAR. Outcomes will be assessed with and without hearing aids. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Between 18 - 85 years old
Key exclusion criteria (1 listed)
- Any reported history of outer or middle ear pathologies • No participants will be excluded based on their gender, race/ethnicity.
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 |
|---|---|---|
| hearing aidsOTC devices for a week | Device | Pre-post single arm design |
Primary outcome
Percentage of Total Confidence
Time frame: 1 week
The Measure of Audiologic Rehabilitation Self-Efficacy for Hearing Aids (MARS-HA), referred to as MARSHA, is a 24-item, validated, self-report questionnaire used to assess an individual's confidence (self-efficacy) in their ability to use and manage hearing aids. Participants rated their confidence for each item (0 - 100%) and the average percentage across all items was calculated as the percentage of total confidence. Scores between pre- and post-conditions were compared and reported here.
4 secondary outcomes
Total Readiness Score on the URICA Scale
Time frame: 1 week
Hearing Aid Satisfaction on SADL Average Score
Time frame: 1 week
Emotional State Total Score
Time frame: 1 week
Hearing-related Quality of Life Total Score
Time frame: 1 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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 hearing aids in people with Hearing Loss, Sensorineural, run by University of Arkansas 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 4 inclusion and 1 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 5 Aug 2026. 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 5 Aug 2026). 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?
Percentage of Total Confidence (time frame: 1 week). 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 5 Aug 2026.