Clinical trial NCT06560918: Self-efficacy-based Auditory Rehabilitation with Over-the-Counter Hearing Aids
Official title: Self-efficacy-based Auditory Rehabilitation to Optimize Real-world Outcomes with Over-the-Counter Hearing Aids: a Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hearing Loss, Sensorineural
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2024-08-19
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Hearing Aid Self-Efficacy
timeFrame: 1 week
Secondary outcomes:
measure: Willingness to adopt hearing aids
timeFrame: 1 week
measure: hearing aid satisfaction
timeFrame: 1 week
measure: emotional state
timeFrame: 1 week
measure: Hearing-related Quality of Life
timeFrame: 1 week
Other outcomes:
Locations:
city: LIttle Rock
country: United States
facility: Department of Audiology, University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
References: