Barriers and Facilitators to OTC Hearing Aids Success
NCT Number: NCT06499805
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hearing Loss, Sensorineural|Presbycusis
Interventions: DEVICE: Audiologist-based fitting|DEVICE: Over-the-counter fitting
Sponsor: Yu-Hsiang Wu
Collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD)|Vanderbilt University Medical Center|University of Manchester
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 360
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-12-01
Completion Date: 2029-04-01
Locations: University of Iowa, Iowa City, Iowa, 52242, United States|Vanderbilt University Medical Center, Nashville, Tennessee, 37232, United States

Summary:
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.

Primary Outcome Measures: 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)., 1-, 6-, and 12-month post-intervention
Secondary Outcome Measures: 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)., 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)., 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)., 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)., 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)., 1-, 6-, and 12-month post-intervention