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Amplification Device
Over-the-Counter Hearing Aids for Age-Related Hearing Loss
N/A
Recruiting
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 change between 6-week post intervention and 12-week post-intervention
Awards & highlights
Study Summary
This trial will test if over-the-counter hearing aids are a viable solution for age-related hearing loss.
Who is the study for?
This trial is for adults with age-related hearing loss that's mild to moderately severe in both ears. Participants must have developed this condition as adults and be fluent English speakers. It's not suitable for those who aren't native English speakers.Check my eligibility
What is being tested?
The study examines the long-term effectiveness of over-the-counter (OTC) hearing aids compared to traditional models requiring professional fitting services. The focus is on changes in user outcomes over a period of three months.See study design
What are the potential side effects?
While there are no direct side effects mentioned, users may experience challenges due to lack of professional support with OTC hearing aids, potentially leading to less optimal use or dissatisfaction over time.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change between 6-week post intervention and 12-week post-intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change between 6-week post intervention and 12-week post-intervention
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change of Hearing aid benefit as measured by the Glasgow Hearing Aid Benefit Profile (GHABP)
Secondary outcome measures
Change of Hearing aid benefit as measured by the Glasgow Hearing Aid Benefit Profile (GHABP) (paper-and-pencil administration)
Change of Hearing aid performance/benefit as measured using the Profile of Hearing Aid Performance / Profile of Hearing Aid Benefit (PHAP / PHAB)
Change of Hearing aid satisfaction as measured by the Hearing Aid Satisfaction Survey (HASS)
+5 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: OTC GroupExperimental Treatment1 Intervention
In this group, the over-the-counter fitting will be used to provide hearing aids.
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Who is running the clinical trial?
Yu-Hsiang WuLead Sponsor
2 Previous Clinical Trials
270 Total Patients Enrolled
National Institute on Deafness and Other Communication Disorders (NIDCD)NIH
328 Previous Clinical Trials
178,251 Total Patients Enrolled
Yu-Hsiang Wu, PhDPrincipal Investigator - University of Iowa
University of Iowa
2 Previous Clinical Trials
270 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have adult-onset hearing loss in both ears.
Research Study Groups:
This trial has the following groups:- Group 1: OTC Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this study only available to senior citizens?
"The age requirements for this study state that potential participants must be between 55 and 85 years old."
Answered by AI
Who does this trial restrict from participating?
"Eligible patients for this clinical trial must have presbycusis, be between 55 and 85 years old, and be one of the 45 total candidates that will be accepted."
Answered by AI
Are there any spots left in this trial for new participants?
"The clinical trial is still recruiting patients, as seen on clinicaltrials.gov. The listing for the study was first created on September 1st, 2019 and was updated on March 31st, 2022."
Answered by AI
Who else is applying?
What site did they apply to?
University of Iowa
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
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