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NCT Number: NCT06560918

Self-efficacy-based Auditory Rehabilitation With Over-the-Counter Hearing Aids

This goal of this study is to learn if a new audiology treatment process called the self-efficacy-based auditory rehabilitation (SEBAR) can improve confidence and success with over-the-counter (OTC) hearing aids.

The main questions it aims to answer are:

* Can the SEBAR improve participants' confidence related to managing their over-the-counter hearing aids? * Can the SEBAR improve participants' willingness to adopt over-the-counter hearing aids, their satisfaction, quality of life, and their emotional state? Researchers will compare these outcomes of the SEBAR with and without wearing OTC hearing aids.

Participants will:

* Visit for one appointment to complete a few questionnaires without OTC hearing aids * Wear a pair of ITC hearing aids for a week and use an app to answer questions about their experiences * Visit for a second appointment to complete the same questionnaires with OTC hearing aids.

Recruiting

Interested in participating?

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Audiology, University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72204, United States

Location status: Recruiting

Location contact

Lipika Sarangi, Ph.D.

CONTACT

[email protected]

501-526-5602

About this study

The proposed study will use a single-arm pre-post intervention research design to achieve both the aims. Participants will complete two appointments. Assessments in the first appointment will serve as the baseline (unaided). This will be followed by a week of OTC HA use and SEBAR implementation in their natural listening situations and the outcome measures will be completed again in appointment 2 (aided) to reflect the impact of wearing OTC HAs. Scores on the outcome measures will be compared between the unaided and the aided conditions to answer both the aims. Both the appointments in the proposed study will be completed in the shared and dedicated research spaces in the Department of Audiology and Speech Pathology, College of Health Professions at the University of Arkansas for Medical Sciences. The research proposal will be submitted for the university's Institutional Review Board's approval Upon arrival participants will complete the consent process in which the PI will describe in detail all study procedures, risks and benefits of the study, and the lack of negative consequences should the participant choose to withdraw from the study or cease participation during data collection. Once the consent form has been signed, the participant will complete two appointments.

Appointment 1: For each interested participant, a standard audiometric procedure will be completed to confirm their eligibility. Once the eligible participants consent, preliminary measures will be completed. Participants will then complete the unaided baseline outcome measures of hearing aid self-efficacy, willingness to adopt HAs, expected HA satisfaction, current emotional state, and quality of life. At this time, OTC HAs will be fitted to the participants and they will receive the SEBAR. Participants will be instructed to use the HAs for at least 4 hours every day for the next week. Finally, the EMA app will be installed on their phone and its use at home will be demonstrated by the researcher.

Appointment 2: At this appointment, data from the EMA app during the one-week field trial will be stored. HAs will be tested using the Verifit 2 to verify if they are providing the required amount of amplification at the participants' preferred settings. All the outcome measures conducted will be repeated to reflect the outcomes after using the OTC HAs for a week.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Between 18 - 85 years old
  • Non-fluctuating, adult-onset, bilateral mild-to-moderate sensorineural hearing loss (average hearing thresholds for 500-3000Hz between 25- and 60-dB HL and no more than 10 dB difference between ears).
  • No previous experience with hearing aids
  • English as their first language with good self-reported health

Exclusion criteria

  • Any reported history of outer or middle ear pathologies • No participants will be excluded based on their gender, race/ethnicity.

Treatment and study plan

hearing aids

Device

OTC devices for a week

Primary outcomes

  1. Hearing Aid Self-Efficacy

    Time frame: 1 week

    Measured in unaided and aided condition

Secondary outcomes

  1. Willingness to adopt hearing aids

    Time frame: 1 week

    Their readiness for adoption using the modified URICA

  2. hearing aid satisfaction

    Time frame: 1 week

    using the SADL

  3. emotional state

    Time frame: 1 week

    in the unaided and aided condition using the PANAS-SF

  4. Hearing-related Quality of Life

    Time frame: 1 week

    Using one-question reflecting degree of change in quality of life

Study contacts

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

Lipika Sarangi, Doctor of Philosophy

CONTACT

[email protected]

501-526-5602

Sponsors and collaborators

Lead sponsor

University of Arkansas

Other

Registry information

Official study title

Self-efficacy-based Auditory Rehabilitation to Optimize Real-world Outcomes With Over-the-Counter Hearing Aids: A Pilot Study

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 19, 2024
Registry last updated
Dec 24, 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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