An interventional study of Audiologist-based fitting and Over-the-counter fitting in Hearing Loss, Sensorineural and Presbycusis, sponsored by Yu-Hsiang Wu. Recruiting at 2 sites in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Yu-Hsiang Wu · Not applicable, Interventional, and Treatment
Hearing aids can improve hearing, communication, and overall quality of life for people with hearing loss. However, not many people use hearing aids. A common reason is that hearing aids are expensive and hard to get. The traditional way to get hearing aids involves multiple visits to licensed audiologists for identifying hearing loss, customizing the aids, and ongoing maintenance. This traditional method is called the AUD pathway.
Over-the-counter (OTC) hearing aids offer a different approach. They aim to make hearing aids more affordable and accessible, encouraging earlier use. In the OTC pathway, users diagnose their own hearing loss and fit and program the hearing aids themselves. Little is known about long-term effects of OTC hearing aids on users.
This study aims to compare the experiences of people who choose the OTC pathway with those who choose the AUD pathway. It takes place in two locations: Iowa City, IA, and Nashville, TN. Participants, who have mild-to-moderate hearing loss, choose their preferred pathway and are followed for 12 months. In the OTC pathway, participants buy their hearing aids directly from OTC companies or retailers. In the AUD pathway, prescription hearing aids and fitting services are provided by audiology clinics at the University of Iowa and Vanderbilt University Medical Center.
Participants are contacted 1, 6, and 12 months after starting to use their hearing aids. Researchers measure their satisfaction about hearing aids and other outcomes. If participants stop using their hearing aids, researchers assess their engagement with post-amplification hearing care. The results from both pathways are then compared.
Although hearing aids (HAs) can improve hearing ability, communication, social and emotional function, and quality of life for people with hearing loss, the adoption rate of HAs is low. A commonly reported barrier to HA uptake is that HAs are not affordable or accessible under the traditional service delivery model, which requires multiple visits to licensed audiologists for identification of hearing loss, customization of the HAs, and continual maintenance and fine-tuning. This hearing healthcare pathway is referred to as the AUD pathway. As an alternative, over-the-counter (OTC) HAs aim to promote earlier HA adoption and improve HA affordability and accessibility. In this healthcare pathway, referred to as the OTC pathway, users self-diagnose hearing loss and fit and program their OTC HAs. Although prior research has supported the feasibility of HA self-fitting and the OTC service-delivery model, little is known about how the OTC pathway impacts users' long-term well-being.
The goal of this study is to characterize the patient journey of individuals who opt for the OTC pathway in comparison to those who select the AUD pathway. The study is a two-site (Iowa City, IA, and Nashville, TN) longitudinal study in which participants choose their preferred healthcare pathways (OTC vs. AUD), and their HA outcomes are tracked for 12 months. Adults with bilateral mild-to-moderate hearing loss are recruited from the community. Upon entering the study, participants choose their preferred pathway and then proceed with the purchase of HAs. In the OTC pathway, participants purchase their chosen OTC HAs directly from OTC companies or retailers. In the AUD pathway, prescription HAs and fitting services are offered by the audiology clinics at the University of Iowa and Vanderbilt University Medical Center. Participants are contacted 1, 6, and 12 months after they begin using their HAs. During each contact, HA outcomes (e.g., HA satisfaction) are measured if participants continue using HAs. If participants have abandoned or under-utilized their HAs, their engagement with post-amplification hearing healthcare behaviors (e.g., seeking HAs again) is assessed. The data from the OTC and AUD pathways are then compared.
66 studies on the registry are indexed under Presbycusis; 21 are open to participants now.
This study's planned enrollment of 360 is above 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.
Compared within Presbycusis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Hearing Loss, Sensorineural. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
In this group, the audiologist-based fitting will be used to provide prescription hearing aids.
Device: Audiologist-based fitting
In this group, over-the-counter fitting will be used to provide over-the-counter hearing aids.
Device: Over-the-counter fitting
Description hearing aids will be fitted by audiologists using established procedures.
In this group, over-the-counter hearing aids will be used by subjects. Subjects will take the full initiative and responsibility for learning and using hearing aids.
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-, 6-, and 12-month post-intervention
Overall hearing aid outcome as measured by the International Outcome Inventory for Hearing Aids (IOI-HA)
The IOI-HA is a questionnaire designed to measures hearing aid outcome across multiple domains, including hearing aid use time and satisfaction. The score ranges from 1 (poor outcome) to 5 (great outcome).
Time frame: 1-, 6-, and 12-month post-intervention
Aided hearing-specific quality of life as measured by the the Revised Hearing Handicap Inventory (RHHI).
The RHHI is designed to measure subject's hearing-specific quality of life (i.e., perceived hearing handicap). The score ranges from 0 (no handicap) to 24 (more handicap).
Time frame: 1-, 6-, and 12-month post-intervention
Hearing aid related issues as measured by the Hearing Aid Issues Survey
This questionnaire asks participants to report the frequency of occurrence of 15 common device-related issues (e.g., "whistles", "device hurts ear", and ?too loud?) using a 5-point Likert scale. The score ranges from 15 (no issues) to 75 (more issue).
Time frame: 1-, 6-, and 12-month post-intervention
Hearing aid success as measured by the HA Use Questionnaire
This instrument has three hearing aid use patterns to choose from: full-time use (whenever hearing aids are needed, score=3), part-time use (occasional use, score=2), and non-use (score=1).
Time frame: 1-, 6-, and 12-month post-intervention
Engagement with post-amplification hearing healthcare behaviors measured by the Hearing Healthcare Behavior Questionnaire
This questionnaire measures the participants' engagement with hearing healthcare behaviors after they have abandoned or under-utilized the study HAs (e.g., seeking HAs again). The score ranges from 0 (no engagement) to 1 (full engagement).
Time frame: 1-, 6-, and 12-month post-intervention
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — The proposed research will include data from a total of 360 participants with hearing loss recruited State of Iowa, State of Tennessee and surrounding areas. The final dataset will include self-reported hearing aid outcome data. All datasets and metadata that can be shared will be deposited in the Inter-University Consortium for Political and Social Research (ICPSR).
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: The data will be available no later than the publication of the main findings.
Access criteria: The data will be deposited in the Inter-University Consortium for Political and Social Research (ICPSR), and will be available to the public.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Yu-Hsiang Wu