An interventional study of Over-the-counter fitting in Presbycusis, sponsored by Yu-Hsiang Wu. Completed at 1 site in United States. Open to participants aged 55 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-08-13.
Sponsored by Yu-Hsiang Wu · Not applicable, Interventional, and Health services research
Age-related hearing loss is a substantial national problem due to its high prevalence and significant psychosocial consequences. Although hearing aids (HAs) are the primary intervention for the management of age-related hearing loss, only 15-30% of those who could benefit from HAs actually seek them out. HA adoption rates are even worse for people with lower income and for racial and ethnic minorities. One of the most commonly reported reasons for people not seeking HA intervention is the high cost of HAs and the associated audiological fitting services. Because HAs fitted using the audiologist-based service-delivery model are unaffordable, more and more Americans (1.5 million in 2010) purchase amplification devices via over-the-counter (OTC) service-delivery models to compensate for their impaired hearing.
Although OTC amplification devices are gaining popularity and are regarded as an important option for promoting accessible and affordable hearing healthcare, it is unclear if they are viable solutions for age-related hearing loss as OTC models exclude professional services. Further, although there is some evidence supporting the effectiveness of OTC HAs, all previous studies measured short-term outcomes (e.g., 6 weeks). It is unknown what the long-term outcomes of OTC HAs would look like. The outcomes could improve across time because users may eventually figure out how to use HAs. On the other hand, the outcomes of OTC HAs could become poorer across time because, unlike traditional HA fitting, users do not have professionals to support them. Therefore, the overall goal of this project is to examine the longitudinal changes in OTC HA outcomes over 3 months.
Although hearing aids (HAs) are the first treatment of choice for age-related hearing loss, only 15-30% of those older Americans who could benefit, actually seek HAs out and use them. HA adoption rates are even lower for people with lower income and for racial and ethnic minorities. Although the answer to why so few older adults seek or use amplification is multidimensional, one common thread is that many people believe that HAs fitted using the audiologist-based model cost too much. Therefore, it is not surprising that there has been increased advocacy for a variety of over-the-counter (OTC) service-delivery models, which have increasingly been identified as important options for managing mild-to-moderate age-related hearing loss.
Is the amplification intervention delivered using the OTC model an appropriate solution for age-related hearing loss? Although there is some evidence supporting the effectiveness of OTC HAs, all previous studies measured short-term outcomes (e.g., 6 weeks). It is unknown what the long-term outcomes of OTC HAs would look like. The purpose of this project is to examine the longitudinal changes in OTC HA outcomes over 3 months. Older adults with age-related hearing loss will be recruited. Pre-configured hearing aids (that simulate OTC hearing aids) will be provided to subjects. Subjects will take the full initiative and responsibility for learning and using hearing aids. HA outcomes will be measured at 6-week and 12-week post intervention.
66 studies on the registry are indexed under Presbycusis; 21 are open to participants now.
This study's enrollment of 34 is below the median of 60 across 45 interventional studies indexed under Presbycusis.
Browse Presbycusis studies →Yu-Hsiang Wu is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
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In this group, the over-the-counter fitting will be used to provide hearing aids.
Device: Over-the-counter fitting
In this group, pre-configured hearing aids, which simulate over-the-counter hearing aids, will be provided to subjects. Subjects will take the full initiative and responsibility for learning and using hearing aids.
Hearing Aid Benefit as Measured by the Glasgow Hearing Aid Benefit Profile (GHABP)
The Glasgow Hearing Aid Benefit Profile (GHABP) is a questionnaire that measures hearing aid users' listening experience in four situations (TV listening, small conversation in quiet, conversation in noise, and group conversation). The score ranges from 0 (no benefit) to 5 (lots of benefit). The score at 1-week, 6-week and 12-week post intervention is the primary outcome.
Time frame: 1-week, 6-week, and 12-week post-intervention
Hearing Aid Performance/Benefit as Measured Using the Profile of Hearing Aid Performance (PHAP)
The PHAP is a questionnaire designed to measures the performance of hearing aids in speech communication. The score ranges from 1 (good performance) to 99 (poor performance).
Time frame: 1-week, 6-week, and 12-week post-intervention
Hearing Handicap as Measured by Hearing Handicap Inventory for the Elderly (HHIE) or Hearing Handicap Inventory for Adults (HHIA)
The HHIE and HHIA are questionnaires designed to measure subject's perceived hearing handicap. For subjects order and younger 65 years old, the HHIE and HHIA will be used, respectively. The score ranges from 0 (no handicap) to 100 (more handicap).
Time frame: 1-week, 6-week, and 12-week post-intervention
Hearing Aid Satisfaction as Measured by the Hearing Aid Satisfaction Survey (HASS)
The HASS is a questionnaire developed to measures subject's perceived hearing aid satisfaction. The score ranges from 0 (low satisfaction) to 10 (high satisfaction).
Time frame: 1-week, 6-week, and 12-week post-intervention
Willingness-to-pay
Willingness-to-pay (WTP) estimates the extent to which (in dollars) a subjects, at a maximum, is willing to pay out-of pocket for the amplification devices and the associated services used in the study..
Time frame: 6-week and 12-week post intervention
Quality of Life as Measured by the World Health Organization's Disability Assessment Schedule 2.0 (WHODAS 2.0)
The WHODAS is a questionnaire designed to measure quality of life. The summary score ranges from 0 (No disability) to 100 (Full disability).
Time frame: 1-week, 6-week, and 12-week post-intervention
Hearing Aid Satisfaction as Measured by the Satisfaction With Amplification in Daily Life (SADL)
The SADL is a questionnaire designed to measures subject's perceived hearing aid satisfaction. The score ranges from 1 (low satisfaction) to 7 (high satisfaction).
Time frame: 1-week, 6-week, and 12-week post-intervention
Speech Recognition Performance as Measured by the Connected Speech Test (CST)
The CST is a speech recognition test designed to simulate daily speech communication. The score ranges from 0 (understand no speech) to 100 (understand all speech).
Time frame: 1-week, 6-week, and 12-week post-intervention
Participants were recruited between September 2019 and September 2022. Participants were recruited from the an established participant registry and through mass emails to the University of Iowa community.
| Milestone | OTC Group |
|---|---|
| Started | 34 |
| Completed | 24 |
| Not completed | 10 |
| Withdrew: Coronavirus disease 2019 (covid-19) | 7 |
| Withdrew: Withdrawal by subject | 3 |
The Glasgow Hearing Aid Benefit Profile (GHABP) is a questionnaire that measures hearing aid users' listening experience in four situations (TV listening, small conversation in quiet, conversation in noise, and group conversation). The score ranges from 0 (no benefit) to 5 (lots of benefit). The score at 1-week, 6-week and 12-week post intervention is the primary outcome.
| score on a scale | OTC Group |
|---|---|
| 1-week post-intervention | 3.68 ± 0.695 |
| 6-week post intervention | 3.55 ± 0.648 |
| 12-week post-intervention | 3.63 ± 0.715 |
The PHAP is a questionnaire designed to measures the performance of hearing aids in speech communication. The score ranges from 1 (good performance) to 99 (poor performance).
| score on a scale | OTC Group |
|---|---|
| 1-week post intervention | 30.5 ± 13.7 |
| 6-week post intervention | 30.4 ± 14.5 |
| 12-week post intervention | 29.5 ± 14.3 |
The HHIE and HHIA are questionnaires designed to measure subject's perceived hearing handicap. For subjects order and younger 65 years old, the HHIE and HHIA will be used, respectively. The score ranges from 0 (no handicap) to 100 (more handicap).
| score on a scale | OTC Group |
|---|---|
| 1-week post intervention | 20.2 ± 14.3 |
| 6-week post intervention | 13 ± 10.9 |
| 12-week post intervention | 17.7 ± 16.6 |
The HASS is a questionnaire developed to measures subject's perceived hearing aid satisfaction. The score ranges from 0 (low satisfaction) to 10 (high satisfaction).
| score on a scale | OTC Group |
|---|---|
| 1-week post intervention | 3.6 ± 0.66 |
| 6-week post intervention | 3.5 ± 0.63 |
| 12-week post intervention | 3.5 ± 0.73 |
Willingness-to-pay (WTP) estimates the extent to which (in dollars) a subjects, at a maximum, is willing to pay out-of pocket for the amplification devices and the associated services used in the study..
| dollars | OTC Group |
|---|---|
| 6-week post intervention | 967.7 ± 1040 |
| 12-week post intervention | 1104.7 ± 1312 |
The WHODAS is a questionnaire designed to measure quality of life. The summary score ranges from 0 (No disability) to 100 (Full disability).
| score on a scale | OTC Group |
|---|---|
| 1-week post-intervention | 7.5 ± 7.1 |
| 6-week post-intervention | 6.7 ± 6.5 |
| 12-week post-intervention | 7.5 ± 7.0 |
The SADL is a questionnaire designed to measures subject's perceived hearing aid satisfaction. The score ranges from 1 (low satisfaction) to 7 (high satisfaction).
| score on a scale | OTC Group |
|---|---|
| 1-week post intervention | 4.6 ± 1.3 |
| 6-week post intervention | 4.4 ± 1.2 |
| 12-week post intervention | 4.6 ± 1.4 |
The CST is a speech recognition test designed to simulate daily speech communication. The score ranges from 0 (understand no speech) to 100 (understand all speech).
| score on a scale | OTC Group |
|---|---|
| 1-week post intervention | 64.9 ± 27.8 |
| 6-week post intervention | 79.6 ± 13.5 |
| 12-week post intervention | 76.8 ± 17.1 |
Collected over Adverse events were monitored for each subject during their participation in the study, which averaged 12 weeks from the time the participants entered the study.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| OTC Group | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) |
| Age, Categorical(Participants) | OTC Group |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 7 |
| >=65 years | 17 |
| Age, Continuous(Years) | OTC Group |
|---|---|
| Mean | 70.29 ± 7.68103 |
| Sex: Female, Male(Participants) | OTC Group |
|---|---|
| Female | 11 |
| Male | 13 |
| Ethnicity (NIH/OMB)(Participants) | OTC Group |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 24 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | OTC Group |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 24 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | OTC Group |
|---|---|
| United States | 24 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — The proposed research will include data from a total of 45 participants with hearing loss recruited State of Iowa and surrounding areas. The final dataset will include laboratory data (e.g., speech recognition score) and self-reported demographic and behavioral data (e.g., questionnaire). Contact the principle investigator for data access.
Time frame: The date will be available starting 6 months after publication of the main findings of the trial.
Access criteria: Even though the final dataset will be stripped of identifiers prior to release for sharing, there remains the possibility of deductive disclosure of subjects with the survey data being collected. Thus, we will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate technologies; and (3) a commitment to destroying or returning the data after analyses are completed.
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Yu-Hsiang Wu