Clinical trial NCT06499805: Barriers and Facilitators to OTC Hearing Aids Success
Official title: Barriers and Facilitators to OTC Hearing Aids Success
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hearing Loss, Sensorineural
Presbycusis
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
name: Vanderbilt University Medical Center
name: University of Manchester
First posted: 2024-07-12
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* adult-onset, perceived bilateral mild-to-moderate hearing loss
* no previous hearing aid experience

Exclusion Criteria:

* Non-native speaker of English

Primary outcomes:
measure: Hearing aid satisfaction as measured by the Satisfaction with Amplification in Daily Life (SADL)
timeFrame: 1-, 6-, and 12-month post-intervention
Secondary outcomes:
measure: Overall hearing aid outcome as measured by the International Outcome Inventory for Hearing Aids (IOI-HA)
timeFrame: 1-, 6-, and 12-month post-intervention
measure: Aided hearing-specific quality of life as measured by the the Revised Hearing Handicap Inventory (RHHI).
timeFrame: 1-, 6-, and 12-month post-intervention
measure: Hearing aid related issues as measured by the Hearing Aid Issues Survey
timeFrame: 1-, 6-, and 12-month post-intervention
measure: Hearing aid success as measured by the HA Use Questionnaire
timeFrame: 1-, 6-, and 12-month post-intervention
measure: Engagement with post-amplification hearing healthcare behaviors measured by the Hearing Healthcare Behavior Questionnaire
timeFrame: 1-, 6-, and 12-month post-intervention
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: University of Iowa
name: Yu-Hsiang Wu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Lin FR, Niparko JK, Ferrucci L. Hearing loss prevalence in the United States. Arch Intern Med. 2011 Nov 14;171(20):1851-2. doi: 10.1001/archinternmed.2011.506. No abstract available.
citation: Nelson PB, Perry TT, Gregan M, VanTasell D. Self-Adjusted Amplification Parameters Produce Large Between-Subject Variability and Preserve Speech Intelligibility. Trends Hear. 2018 Jan-Dec;22:2331216518798264. doi: 10.1177/2331216518798264.
citation: Urbanski D, Hernandez H, Oleson J, Wu YH. Toward a New Evidence-Based Fitting Paradigm for Over-the-Counter Hearing Aids. Am J Audiol. 2021 Mar 10;30(1):43-66. doi: 10.1044/2020_AJA-20-00085. Epub 2020 Dec 1.