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

NCT06560918 | Completed Results DMC FDA Device

• 1 other identifier: 297731
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hearing Loss, Sensorineural

Outcome Measures

Primary Outcomes (1)

• Percentage of Total Confidence

  The Measure of Audiologic Rehabilitation Self-Efficacy for Hearing Aids (MARS-HA), referred to as MARSHA, is a 24-item, validated, self-report questionnaire used to assess an individual's confidence (self-efficacy) in their ability to use and manage hearing aids. Participants rated their confidence for each item (0 - 100%) and the average percentage across all items was calculated as the percentage of total confidence. Scores between pre- and post-conditions were compared and reported here.

  1 week

Secondary Outcomes (4)

• Total Readiness Score on the URICA Scale

  1 week

• Hearing Aid Satisfaction on SADL Average Score

  1 week

• Emotional State Total Score

  1 week

• Hearing-related Quality of Life Total Score

  1 week

Study Arms (1)

Pre-post single arm design

EXPERIMENTAL

Participants will wear the hearing aids for a week while receiving the SEBAR. Outcomes will be assessed with and without hearing aids.

Device: hearing aids

Interventions

hearing aids DEVICE

OTC devices for a week

Pre-post single arm design

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

Department of Audiology, University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72204, United States

Location

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Interventions

Hearing Aids

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Wearable Electronic Devices; Electrical Equipment and Supplies; Equipment and Supplies; Sensory Aids

Results Point of Contact

• Title: Lipika Sarangi, Assistant professor
• Organization: University of Arkansas for Medical Sciences

Lsarangi@uams.edu

5015265602

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2024
• First Posted: August 19, 2024
• Study Start: October 30, 2024
• Primary Completion: January 31, 2026
• Study Completion: January 31, 2026
• Last Updated: August 5, 2026
• Results First Posted: August 5, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)