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Procedure

OTC vs Prescription Hearing Aids for Hearing Loss

N/A
Waitlist Available
Led By Yu-Hsiang Wu, PhD
Research Sponsored by Yu-Hsiang Wu
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-, 6-, and 12-month post-intervention
Awards & highlights
No Placebo-Only Group

Summary

This trial compares the experiences of people who use over-the-counter (OTC) hearing aids with those who use traditional prescription hearing aids. The study takes place in Iowa City, IA, and Nashville,

Who is the study for?
This trial is for individuals with mild-to-moderate hearing loss, including sensorineural and age-related types. Participants can choose to fit their own over-the-counter (OTC) hearing aids or have them fitted by an audiologist. The study excludes certain people based on criteria not specified here.
What is being tested?
The study compares user experiences between self-fitted OTC hearing aids and those fitted by audiologists (AUD pathway). It tracks participant satisfaction over a year in Iowa City, IA, and Nashville, TN, with check-ins at 1, 6, and 12 months.
What are the potential side effects?
While specific side effects are not mentioned for the interventions being studied (OTC vs AUD fitting), general issues may include discomfort with device fit or challenges in self-diagnosing and programming the correct amplification.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-, 6-, and 12-month post-intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-, 6-, and 12-month post-intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Hearing aid satisfaction as measured by the Satisfaction with Amplification in Daily Life (SADL)
Secondary study objectives
Aided hearing-specific quality of life as measured by the the Revised Hearing Handicap Inventory (RHHI).
Engagement with post-amplification hearing healthcare behaviors measured by the Hearing Healthcare Behavior Questionnaire
Hearing aid related issues as measured by the Hearing Aid Issues Survey
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: OTC (over-the-counter)Experimental Treatment1 Intervention
In this group, over-the-counter fitting will be used to provide over-the-counter hearing aids.
Group II: AUD (audiologist-based)Active Control1 Intervention
In this group, the audiologist-based fitting will be used to provide prescription hearing aids.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Over-the-counter fitting
2019
N/A
~40

Find a Location

Who is running the clinical trial?

Yu-Hsiang WuLead Sponsor
3 Previous Clinical Trials
354 Total Patients Enrolled
Vanderbilt University Medical CenterOTHER
902 Previous Clinical Trials
938,460 Total Patients Enrolled
University of ManchesterOTHER
357 Previous Clinical Trials
618,016 Total Patients Enrolled
~240 spots leftby Mar 2029
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