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Hearing Aid Delivery Models 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 6-week post-intervention
Awards & highlights
Study Summary
This trial will compare the outcomes, value, and candidacy of three hearing aid models to find the most effective way to provide accessible and affordable hearing healthcare.
Who is the study for?
This trial is for adults with age-related hearing loss who have never used hearing aids before. Participants must be native English speakers and have mild-to-moderately severe sensorineural hearing loss in both ears.Check my eligibility
What is being tested?
The study is testing three ways to fit hearing aids: traditional fitting by an audiologist, over-the-counter fitting without professional help, and a hybrid of the two. It's a double-blinded trial, meaning neither the researchers nor participants know who receives which type of fitting.See study design
What are the potential side effects?
Since this trial involves non-invasive procedures related to fitting hearing aids rather than medication or surgery, there are no direct side effects associated with the interventions being tested.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6-week post-intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-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
Hearing aid benefit as measured by the Glasgow Hearing Aid Benefit Profile (GHABP)
Secondary outcome measures
Hearing aid performance/benefit as measured using the Profile of Hearing Aid Performance (PHAP)
Hearing aid satisfaction as measured by the Hearing Aid Satisfaction Survey (HASS)
Hearing aid satisfaction as measured by the Satisfaction with Amplification in Daily Life (SADL)
+4 moreTrial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: OTC-PlusExperimental Treatment1 Intervention
In this group, the hybrid fitting will be used to provide hearing aids.
Group II: OTC (over-the-counter)Experimental Treatment1 Intervention
In this group, the over-the-counter fitting will be used to provide hearing aids.
Group III: AUD (audiologist-based)Active Control1 Intervention
In this group, the audiologist-based fitting will be used to provide hearing aids.
Find a Location
Who is running the clinical trial?
Yu-Hsiang WuLead Sponsor
2 Previous Clinical Trials
75 Total Patients Enrolled
Vanderbilt University Medical CenterOTHER
857 Previous Clinical Trials
671,953 Total Patients Enrolled
National Institute on Deafness and Other Communication Disorders (NIDCD)NIH
330 Previous Clinical Trials
178,231 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have never used a hearing aid before.I have adult-onset hearing loss in both ears.You have not used a hearing aid before.
Research Study Groups:
This trial has the following groups:- Group 1: AUD (audiologist-based)
- Group 2: OTC (over-the-counter)
- Group 3: OTC-Plus
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.
How many participants are involved in this clinical investigation?
"Affirmative, current data on the clinicaltrials.gov website demonstrates that this research is currently enrolling volunteers. It was initially posted in February of 2019 and has been revised as recently as March 18th 2022. A total of 240 individuals will be accepted through 2 sites."
Answered by AI
Is there an avenue for me to join this experiment?
"This medical trial requires the recruitment of 240 elderly adults aged between 55 and 85 with adult-onset, bilateral presbycusis that falls in the mild-to-moderately severe range who have not previously used hearing aids."
Answered by AI
Are there still open participation slots for this experiment?
"Affirmative. Data available on clinicaltrials.gov indicates this research trial is presently looking for participants. Initially posted on February 22nd 2019, the study requires 240 subjects from 2 distinct centres to participate in it."
Answered by AI
Are elderly individuals being enlisted for this research endeavor?
"To join this study, patients must be beyond the age of 55 and below 85 years old."
Answered by AI
Who else is applying?
What site did they apply to?
University of Iowa
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
Recent research and studies
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