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Behavioural Intervention
Over-the-Counter Hearing Aids for Sensorineural Hearing Loss
N/A
Recruiting
Research Sponsored by University of Arkansas
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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)
Must not have
Any reported history of outer or middle ear pathologies
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 week
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to see if a new audiology treatment process called SEBAR can help people feel more confident and successful when using over-the-counter hearing aids. Participants will complete questionnaires, wear in-the
Who is the study for?
This trial is for adults aged 18-85 with adult-onset, bilateral mild-to-moderate sensorineural hearing loss who have never used hearing aids and speak English as their first language. They should be in good health and have stable hearing loss with similar levels in both ears.
What is being tested?
The study tests a new audiology treatment called SEBAR to see if it boosts confidence and success using over-the-counter (OTC) hearing aids. It will compare participants' willingness to adopt OTC aids, satisfaction, quality of life, and emotional state before and after the intervention.
What are the potential side effects?
While not explicitly mentioned, potential side effects may include discomfort from wearing the devices, challenges adapting to amplified sounds or managing the aids. Emotional impacts could arise from changes in auditory experiences.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 85 years old.
Select...
I have adult-onset hearing loss that is mild to moderate and similar in both ears.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had ear problems affecting the outer or middle ear.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 week
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 week
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Hearing Aid Self-Efficacy
Secondary study objectives
Hearing-related Quality of Life
Willingness to adopt hearing aids
emotional state
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Pre-post single arm designExperimental Treatment1 Intervention
Participants will wear the hearing aids for a week while receiving the SEBAR. Outcomes will be assessed with and without hearing aids.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
hearing aids
2018
Completed Phase 1
~330
Find a Location
Who is running the clinical trial?
University of ArkansasLead Sponsor
494 Previous Clinical Trials
150,303 Total Patients Enrolled
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