Barriers and Facilitators to OTC Hearing Aids Success
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-89
SponsorYu-Hsiang Wu
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
adult-onset, perceived bilateral mild-to-moderate hearing loss
no previous hearing aid experience
Disqualifiers
Non-native speaker of English
Trial design
Design model
Parallel
Treatments tested in this trial
Audiologist-based fitting
DeviceDescription hearing aids will be fitted by audiologists using established procedures.
Over-the-counter fitting
DeviceIn 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.
Treatment groups
360 Participants
are divided into 2 treatment groupsGroup A: AUD (audiologist-based)Active comparator 1 intervention
Group B: OTC (over-the-counter)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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-interventionSecondary outcomes
1
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-intervention2
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-intervention3
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-intervention4
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-interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Yu-Hsiang Wu
Lead sponsor
University of Iowa
Sponsor institution
National Institute on Deafness and Other Communication Disorders (NIDCD)
Collaborator
Vanderbilt University Medical Center
Collaborator
University of Manchester
Collaborator
Source ClinicalTrials.gov