An interventional study of hearing aids in Hearing Loss, Sensorineural, sponsored by University of Arkansas. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-05.
Sponsored by University of Arkansas · Not applicable, Interventional, and Treatment
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:
Participants will:
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.
371 studies on the registry are indexed under Hearing Loss, Sensorineural; 112 are open to participants now.
This study's enrollment of 5 is below the median of 32 across 264 interventional studies indexed under Hearing Loss, Sensorineural.
Browse Hearing Loss, Sensorineural studies →University of Arkansas is the lead sponsor of 391 studies on the registry; 39 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 34 (92%) have results posted.
Counted across the registry records on this site, refreshed daily.
Between 18 - 85 years old
Exclusion Criteria:
Participants will wear the hearing aids for a week while receiving the SEBAR. Outcomes will be assessed with and without hearing aids.
Device: hearing aids
OTC devices for a week
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.
Time frame: 1 week
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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 1 week
Participants recruited from the community through flyers.
| Milestone | Pre-post Single Arm Design |
|---|---|
| Started | 5 |
| Completed | 5 |
| Not completed | 0 |
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.
| Mean Difference Score on a scale | Pre (Unaided) | Post (Aided) |
|---|---|---|
| Percentage of Total Confidence | 81.75 ± 8.31 | 91.99 ± 11.60 |
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.
| scores on a scale | Pre (Unaided) | Post (Aided) |
|---|---|---|
| Total Readiness Score on the URICA Scale | 10.63 ± 1.74 | 10.76 ± 1.27 |
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).
| score on the scale | Pre (Unaided) | Post (Aided) |
|---|---|---|
| Hearing Aid Satisfaction on SADL Average Score | 4.06 ± 0.82 | 4.96 ± 0.84 |
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.
| score on the scale | Pre (Unaided) | Post (Aided) |
|---|---|---|
| Emotional State Total Score | 18.4 ± 0.22 | 17.8 ± 0.24 |
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.
| score on the scale | Pre (Unaided) | Post (Aided) |
|---|---|---|
| Hearing-related Quality of Life Total Score | 1 ± 2.83 | 2.4 ± 3.97 |
Collected over Through study completion, an average of 1 week. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pre-post Single Arm Design | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
There was no difference in these numbers
| Age, Continuous(years) | Pre-post Single Arm Design |
|---|---|
| Mean | 71 ± 7.25 |
| Sex/Gender, Customized(Participants) | Pre-post Single Arm Design |
|---|---|
| Gender — Male | 4 |
| Gender — Female | 1 |
| Race/Ethnicity, Customized(Participants) | Pre-post Single Arm Design |
|---|---|
| Race-Ethnicity — White | 5 |
| Race-Ethnicity — Black | 0 |
| Percentage of total confidence(percentage) | Pre-post Single Arm Design |
|---|---|
| Mean | 81.75 ± 8.31 |
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University of Arkansas