An interventional study of Hearing Evaluation and Over-the-Counter Hearing Aid (OTC HA) Fitting and Orientation in Hearing Loss, sponsored by University of Alabama, Tuscaloosa. Recruiting at 1 site in United States. Open to participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-30.
Sponsored by University of Alabama, Tuscaloosa · Not applicable, Interventional, and Treatment
This project will address quality of care issues associated with hearing loss in adults who have mild-to-moderate hearing loss and who have no access to hearing healthcare. Through the use of three different interventions involving over-the-counter hearing aids, it will lead to options that will increase access and affordability of hearing healthcare for adults with mild-to-moderate hearing loss.
The design for this study is outlined below according to each Aim.
Aim 1: To identify the effectiveness of over-the-counter hearing aids (OTC HAs) for decreasing hearing handicap and improving speech perception in adults with no access to hearing health care.
Aim 2: To implement an adult aural rehabilitation (AR) program for those without access to hearing health care to improve OTC HA benefit, promote OTC HA use and lead to increased quality of life (QOL).
Aim 1 will assess the effectiveness of OTC HAs for our participant population and Aim 2 will implement an AR program. With Aim 1, hearing loss will be assessed and an OTC HA will be provided. Prior to the hearing evaluation, participants will be randomly placed in one of three groups to assess the effectiveness of the AR program (Aim 2). The three groups include those who will receive the current best practices care from an audiologist (ABP), those who will receive the ABP plus an aural rehabilitation program (ABP+AR), and finally, those who will receive only an OTC HA without assistance from an audiologist for providing programming, maintenance or care information (OTC-only). Both the ABP and OTC-only groups initially will attend general health information sessions in-place of the AR program. Local health care providers who have training in general health areas such as nutrition, diabetes, obesity, and heart health to name a few, will provide the General Health and Wellness programming. Once the ABP+AR groups have completed their AR sessions, the ABP and the OTC-only groups will attend the AR programming sessions. This testing layout and schedule is provided in the table below.
Randomization will occur for each county visited and for the participants. Specifically, five counties will each receive a code and these codes will be randomized to determine when the study will take place in that area. All five regions will be included over a one-year period. Participant randomization will occur by generating three groups of random participant numbers and then assigning each participant to their designated group. Only the PI and the project manager will have access to the randomization lists. The PI will generate the randomization lists and the Project Manager will assign the participants accordingly to each group. The randomization lists will be kept on a password-protected computer and only accessible by the PI or Project Manager.
Audiologists will be blinded to the intervention condition for participants. Specifically, two audiologists (A1 and A2) will conduct the initial hearing evaluations. A2 will perform the OTC HA settings and orientations and a third audiologist (A3) will perform the follow-up speech perception testing in weeks 8 - 9. A second post-speech perception testing for all participants in week 14 will be conducted by A1.
The entire program will take place over a 14-week period for one county at a time. County 1 will begin at Week 1 and the remaining four regions will be stratified such that testing will begin at Week 9, 10 or 11 consecutively for each region. The stratification will be done to ensure that testing takes place in each area over a one-year period, and also, to avoid simultaneous testing at two sites. Finally, all participants who complete the study in years 1 and 2 will be invited back to complete speech perception testing and the AR surveys one year after they complete the study.
Exclusion Criteria:
This experimental group will receive a hearing evaluation, an over-the-counter hearing aid fitting and orientation, and four-weeks of an aural rehabilitation program conducted by specially-trained community health workers. Additionally, these adults will complete pre- and post-questionnaires and speech perception testing.
Behavioral: Hearing Evaluation · Device: Over-the-Counter Hearing Aid (OTC HA) Fitting and Orientation · Behavioral: Four Weeks of Aural Rehabilitation
This comparison group of adults with hearing loss will receive a hearing evaluation and over-the-counter hearing aid fitting and orientation. The aural rehabilitation program will not be provided initially. These participants will complete pre- and post-questionnaires and speech perception testing.
Behavioral: Hearing Evaluation · Behavioral: Four Weeks of Aural Rehabilitation
This comparison group of adults with hearing loss will receive a hearing evaluation. They will be provided with over-the-counter hearing aids but the audiologist will not assist with fitting the aids or providing an orientation. This arm mimics what would happen when a consumer privately purchases over-the-counter hearing aids. They will complete pre- and post-questionnaires and speech perception testing.
Behavioral: Hearing Evaluation · Device: Provision of Over-the-Counter Hearing Aids
Behavioral thresholds for pure tones will be conducted along with speech perception measures.
Study participants will be fitted with binaural OTC HAs in addition to receiving information on how to use and care for their devices.
Also known as: Over-the-Counter Hearing Aid Fitting and Orientation
Participants will receive four weeks of information sessions to help them adjust to their over-the-counter hearing aid and their hearing loss.
Study participants will receive binaural OTC HAs. Participants will fit their OTC HAs based on manufacturer guidelines without the help of an audiologist.
Also known as: Provision of Over-the Counter Hearing Aids
Measuring Change in the Hearing Handicap Inventory for Elderly (HHIE) Outcomes
Twenty-five questions of the Hearing Handicap Inventory for Elderly (HHIE) measure emotional and social/situational consequences of hearing loss, including feelings of embarrassment, social isolation, and frustration. Scores range from 0 to 100 with higher scores indicative of poorer performance.
Time frame: A baseline outcome will be obtained prior to over-the-counter hearing aid fitting. Outcomes will be measured at weeks 4 to 7 of intervention, during week 14 of the intervention, and through study completion, or 1 assessment each year.
Measuring Change in International Outcome Inventory for Hearing Aids (IOI-HA) Outcomes
The International Outcome Inventory for Hearing Aids (IOI-HA) is an eight-item inventory that assesses daily use of over-the-counter hearing aid use, over-the-counter hearing aid benefit, and activity limitations to name a few. This is a scaled qualitative measure that assesses outcomes over time.
Time frame: A baseline outcome will be obtained prior to over-the-counter hearing aid fitting. Outcomes will be measured at weeks 4 to 7 of intervention, during week 14 of the intervention, and through study completion, or 1 assessment each year.
Measuring Change in Northwestern University-6 (NU-6) Word Recognition Outcomes
This test will assess word recognition in quiet. Binaural testing will be performed at 65 dBA in the sound field. A percentage correct word understanding will be obtained. A higher scores is indicative of better performance.
Time frame: A baseline outcome will be obtained prior to over-the-counter hearing aid fitting. Outcomes will be measured at weeks 8 to 9 of intervention, during week 14 of the intervention, and through study completion, or 1 assessment each year.
Measuring Change in Quick Speech In Noise (SIN) Word Recognition Outcomes
The participant will be instructed to repeat the presented sentences in noise via a speaker presented at 0˚ azimuth. The correctly identified target words will be totaled and then subtracted from 25.5 to obtain the Signal-to-Noise Ratio (SNR) loss. A higher score is indicative of poorer performance.
Time frame: A baseline outcome will be obtained prior to over-the-counter hearing aid fitting. Outcomes will be measured at weeks 8 to 9 of intervention, during week 14 of the intervention, and through study completion, or 1 assessment each year.
Measuring Change in the Client Oriented Scale of Improvement (COSI)
The Client Oriented Scale of Improvement (COSI) is a 16-item clinician-administered survey that addresses how the participants' five most important listening difficulties have been alleviated with over-the-counter hearing aid use. This is a qualitative scale that measures improvement over time.
Time frame: A baseline outcome will be obtained prior to over-the-counter hearing aid fitting. Outcomes will be measured at weeks 4 to 7 of intervention, during week 14 of the intervention, and through study completion, or 1 assessment each year.
Measuring Change in the Abbreviated Profile of Hearing Aid Benefit (APHAB)
The Abbreviated Profile of Hearing Aid Benefit (APHAB) is a 24-item survey that computes OTC HA-benefit by calculating the difference between aided and unaided conditions. It is a qualitative scale that measures the extent of change over time.
Time frame: A baseline outcome will be obtained prior to over-the-counter hearing aid fitting. Outcomes will be measured at weeks 4 to 7 of intervention, during week 14 of the intervention, and through study completion, or 1 assessment each year.
Measuring Change in the World Health Organization Quality of Life-Age (WHOQOL-AGE) Survey
The World Health Organization Quality of Life-Age (WHOQOL-AGE) survey is a 13-item scale that examines quality of life in adults as they age. It is a qualitative rating scale that can help to identify change in performance over time.
Time frame: A baseline outcome will be obtained prior to over-the-counter hearing aid fitting. Outcomes will be measured at weeks 4 to 7 of intervention, during week 14 of the intervention, and through study completion, or 1 assessment each year.
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Plan to share: Yes — All of the individual participant data that has been collected during this clinical trial and after it has been de-identified will be shared.
Supporting information: Study protocol
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University of Alabama, Tuscaloosa