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Coupler-based Fitting Approach for Hearing Aids Replacement
N/A
Waitlist Available
Led By Sherri Lyn Smith, PhD
Research Sponsored by VA Office of Research and Development
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 month
Awards & highlights
Study Summary
This trial is testing a new way to fit hearing aids that doesn't require the person to come into the clinic, which would be more convenient for patients.
Who is the study for?
This trial is for Veterans aged 18-85 with sensorineural hearing loss, who can understand English and have at least a moderate ability to recognize words in quiet. They should be experienced users of VA-issued hearing aids seeking replacements of the same style and make, without significant ear pathology or recent changes in their hearing level.Check my eligibility
What is being tested?
The study tests if a new fitting approach using a coupler (a device that simulates the ear) for replacement hearing aids is effective. This could allow Veterans to receive their aids by mail without attending an appointment. Different styles of behind-the-ear (BTE) and in-the-ear (ITE) devices are being compared.See study design
What are the potential side effects?
Since this trial involves non-invasive procedures related to fitting hearing aids, there are no direct side effects like those seen with medications. However, participants may experience discomfort or dissatisfaction with the fit or performance of the replacement hearing aids.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
deviation from target (in dB)
Secondary outcome measures
Abbreviate Profile of Hearing Aid Benefit
Client-Oriented Scale of Improvement
Hearing Aids
+1 moreTrial Design
7Treatment groups
Experimental Treatment
Active Control
Group I: Study 3 (experimental open-fit)Experimental Treatment1 Intervention
Experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with OPEN coupling that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial.
Group II: Study 3 (experimental closed-fit)Experimental Treatment1 Intervention
Experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with CLOSED coupling that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial.
Group III: Study 1 (In-the-Ear) GroupExperimental Treatment1 Intervention
Experienced users of in-the-ear (ITE) hearing aids will receive replacement ITE hearing aids that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial.
Group IV: Study 1 (Behind-the-Ear) GroupExperimental Treatment1 Intervention
Experienced users of behind-the-ear (BTE) hearing aids will receive replacement BTE hearing aids that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial.
Group V: Study 2 (Open-Fit corrections)Active Control1 Intervention
Participants with hearing loss will be fitted monaurally with 12 stock non-custom, receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids using the standard in-situ approach and test box measures will be made of each fitting to develop correction factors for these styles.
Group VI: Study 3 (open-fit comparison)Active Control1 Intervention
This group will serve as the active comparator group for experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with OPEN coupling using the standard of care approach, then undergoing a 4-week field trial.
Group VII: Study 3 (closed-fit comparison)Active Control1 Intervention
This group will serve as the active comparator group for experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with CLOSED coupling using the standard of care approach, then undergoing a 4-week field trial.
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,290 Total Patients Enrolled
15 Trials studying Hearing Loss
2,885 Patients Enrolled for Hearing Loss
Sherri Lyn Smith, PhDPrincipal InvestigatorDurham VA Medical Center, Durham, NC
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a problem with your outer or middle ear that can be found during ear exams or hearing tests.Your hearing has significantly worsened, as shown by a hearing test, while using your current hearing aids.Your hearing is about the same in both ears, with no big differences in how well you can hear different pitches.You do not have a phone or do not use a phone.People who already use hearing aids and are getting new ones from the VA that are the same style and brand as their current ones.You have a high score on a test that measures memory and thinking skills.Your hearing loss is not too severe (defined as less than 60 decibels at certain frequencies).Veterans between 18 and 85 years old with hearing loss caused by issues in the inner ear.You have a hearing loss that is not too severe (less than 60 decibels) at certain frequencies.You can understand at least half of the words spoken to you in a quiet environment during a hearing test.People who already wear hearing aids and need to get new ones of the same type and brand from the VA.Your hearing in both ears is similar, with no more than a 20 decibel difference in hearing ability at two different frequencies.We are looking for Veterans between 18 and 85 years old who have hearing loss caused by damage to the inner ear or nerve pathways.Participants in Study 1 and 3 who use hearing aids can only get new hearing aids if they are the same type and brand as their current ones provided by the VA.I'm sorry, but without the specific details of Study 1 and Study 3, I am unable to provide a simplified summary of their screening criteria. Could you please provide more information about these studies?
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
For which demographic would this trial be most suitable?
"This study seeks approximately 252 persons with hearing loss in the age range of 18 to 85."
Answered by AI
Is this medical experiment open to people younger than 35 years old?
"This clinical trial is open to adults aged 18 or older and younger than 85."
Answered by AI
What is the cumulative population size of individuals partaking in this investigation?
"Affirmative. Clinicaltrials.gov outlines that this research is currently looking for enrollees, with the original posting being on October 28th 2019 and most recent edit occurring July 14th 2022. This investigation aims to have 252 participants from a single location join in its findings."
Answered by AI
Are there any opportunities to participate in this research currently available?
"Reportedly, this medical study is presently recruiting participants. The trial was initially posted on October 28th 2019 and the most recent revision took place on July 14th 2022."
Answered by AI
Who else is applying?
What state do they live in?
South Carolina
North Carolina
How old are they?
18 - 65
What site did they apply to?
Durham VA Medical Center, Durham, NC
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I currently need hearing aids and have been suffering from loss of hearing for some time. Due to financial constraints, I have not yet been able to afford them but plan on getting them next year. In the meantime, I go without and just can't hear, with causes miscommunications and other issues. I plan on getting bte hearing aids through Medicare next year. I deal with another disease that makes trips to the doctor's office for fittings difficult, and sometimes unbearable for me. Having out-of-office fitting options would be very beneficial for my condition and I would love to be part of creating or testing the feasibility of that process.
PatientReceived no prior treatments
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