Barriers and Facilitators to OTC Hearing Aids Success

NCT ID: NCT06499805

Last Updated: 2025-05-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 360 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-15
• Study Completion Date: 2029-04-01

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.

Conditions

Hearing Loss, Sensorineural; Presbycusis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AUD (audiologist-based)

In this group, the audiologist-based fitting will be used to provide prescription hearing aids.

Group Type: ACTIVE_COMPARATOR

Audiologist-based fitting

Intervention Type: DEVICE

Description hearing aids will be fitted by audiologists using established procedures.

OTC (over-the-counter)

In this group, over-the-counter fitting will be used to provide over-the-counter hearing aids.

Group Type: EXPERIMENTAL

Over-the-counter fitting

Intervention Type: DEVICE

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.

Interventions

Audiologist-based fitting

Description hearing aids will be fitted by audiologists using established procedures.

Intervention Type: DEVICE

Over-the-counter fitting

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role: collaborator

Vanderbilt University Medical Center

OTHER

Sponsor Role: collaborator

University of Manchester

OTHER

Sponsor Role: collaborator

Yu-Hsiang Wu

OTHER

Sponsor Role: lead

Responsible Party

Yu-Hsiang Wu

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Yu-Hsiang Wu, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

University of Iowa

Iowa City, Iowa, United States

Site Status: RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Yu-Hsiang Wu, PhD

Role: CONTACT

yu-hsiang-wu@uiowa.edu

319-335-8728

Elizabeth Stangl, AuD

Role: CONTACT

elizabeth-stangl@uiowa.edu

319-335-9758

Facility Contacts

Yu-Hsiang Wu, PhD

Role: primary

Todd Ricketts, PhD

Role: primary

References

Brody L, Wu YH, Stangl E. A Comparison of Personal Sound Amplification Products and Hearing Aids in Ecologically Relevant Test Environments. Am J Audiol. 2018 Dec 6;27(4):581-593. doi: 10.1044/2018_AJA-18-0027.

Reference Type: BACKGROUND

PMID: 30458521 (View on PubMed)

Chien W, Lin FR. Prevalence of hearing aid use among older adults in the United States. Arch Intern Med. 2012 Feb 13;172(3):292-3. doi: 10.1001/archinternmed.2011.1408. No abstract available.

Reference Type: BACKGROUND

PMID: 22332170 (View on PubMed)

Gopinath B, Schneider J, Hartley D, Teber E, McMahon CM, Leeder SR, Mitchell P. Incidence and predictors of hearing aid use and ownership among older adults with hearing loss. Ann Epidemiol. 2011 Jul;21(7):497-506. doi: 10.1016/j.annepidem.2011.03.005. Epub 2011 Apr 21.

Reference Type: BACKGROUND

PMID: 21514179 (View on PubMed)

Humes LE, Rogers SE, Quigley TM, Main AK, Kinney DL, Herring C. The Effects of Service-Delivery Model and Purchase Price on Hearing-Aid Outcomes in Older Adults: A Randomized Double-Blind Placebo-Controlled Clinical Trial. Am J Audiol. 2017 Mar 1;26(1):53-79. doi: 10.1044/2017_AJA-16-0111.

Reference Type: BACKGROUND

PMID: 28252160 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22083573 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30191767 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33264578 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

R01DC015997

Identifier Type: NIH

Identifier Source: secondary_id

View Link

202404595

Identifier Type: -

Identifier Source: org_study_id