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NCT Number: NCT06499805

Barriers and Facilitators to OTC Hearing Aids Success

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.

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Key information

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Iowa, Iowa City, Iowa, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Non-native speaker of English

Treatment and study plan

Audiologist-based fitting

Device

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

Over-the-counter fitting

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.

Primary outcomes

  1. Hearing aid satisfaction as measured by the Satisfaction with Amplification in Daily Life (SADL)

    Time frame: 1-, 6-, and 12-month post-intervention

    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).

Secondary outcomes

  1. Overall hearing aid outcome as measured by the International Outcome Inventory for Hearing Aids (IOI-HA)

    Time frame: 1-, 6-, and 12-month post-intervention

    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).

  2. Aided hearing-specific quality of life as measured by the the Revised Hearing Handicap Inventory (RHHI).

    Time frame: 1-, 6-, and 12-month post-intervention

    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).

  3. Hearing aid related issues as measured by the Hearing Aid Issues Survey

    Time frame: 1-, 6-, and 12-month post-intervention

    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).

  4. Hearing aid success as measured by the HA Use Questionnaire

    Time frame: 1-, 6-, and 12-month post-intervention

    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).

  5. Engagement with post-amplification hearing healthcare behaviors measured by the Hearing Healthcare Behavior Questionnaire

    Time frame: 1-, 6-, and 12-month post-intervention

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Elizabeth Stangl, AuD

CONTACT

[email protected]

319-335-9758

Yu-Hsiang Wu, PhD

CONTACT

[email protected]

319-335-8728

Sponsors and collaborators

Lead sponsor

Yu-Hsiang Wu

Other

Collaborators

  • National Institute on Deafness and Other Communication Disorders (NIDCD)
  • University of Manchester
  • Vanderbilt University Medical Center

Registry information

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Jul 12, 2024
Registry last updated
May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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