Study 1 - BTE hearing aids for Hearing Loss

Durham VA Medical Center, Durham, NC, Durham, NC
Hearing LossStudy 1 - BTE hearing aids - Device
Eligibility
18 - 85
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Hearing Loss

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
N/A

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: 1 month

1 month
Abbreviate Profile of Hearing Aid Benefit
Client-Oriented Scale of Improvement
Hearing Aids
Satisfaction with Amplification in Daily Life
deviation from target (in dB)

Trial Safety

Phase-Based Safety

1 of 3

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

7 Treatment Groups

Study 2 (Open-Fit corrections)
1 of 7
Study 3 (open-fit comparison)
1 of 7
Study 3 (closed-fit comparison)
1 of 7
Study 1 (In-the-Ear) Group
1 of 7
Study 1 (Behind-the-Ear) Group
1 of 7
Study 3 (experimental closed-fit)
1 of 7
Study 3 (experimental open-fit)
1 of 7

Active Control

Experimental Treatment

252 Total Participants · 7 Treatment Groups

Primary Treatment: Study 1 - BTE hearing aids · No Placebo Group · N/A

Study 1 (In-the-Ear) Group
Device
Experimental Group · 1 Intervention: Study 1 - ITE hearing aids · Intervention Types: Device
Study 1 (Behind-the-Ear) Group
Device
Experimental Group · 1 Intervention: Study 1 - BTE hearing aids · Intervention Types: Device
Study 3 (experimental closed-fit)
Device
Experimental Group · 1 Intervention: Study 3 (experimental closed-fit) · Intervention Types: Device
Study 3 (experimental open-fit)
Device
Experimental Group · 1 Intervention: Study 3 (experimental open-fit) · Intervention Types: Device
Study 2 (Open-Fit corrections)NoIntervention Group · 1 Intervention: Study 2 (Open-Fit corrections) · Intervention Types:
Study 3 (open-fit comparison)
Device
ActiveComparator Group · 1 Intervention: Study 3 (open-fit comparison) · Intervention Types: Device
Study 3 (closed-fit comparison)
Device
ActiveComparator Group · 1 Intervention: Study 3 (closed-fit comparison) · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 1 month

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,511 Previous Clinical Trials
2,730,495 Total Patients Enrolled
15 Trials studying Hearing Loss
2,878 Patients Enrolled for Hearing Loss
Sherri Lyn Smith, PhDPrincipal InvestigatorDurham VA Medical Center, Durham, NC

Eligibility Criteria

Age 18 - 85 · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The study is looking for veterans between the ages of 18 and 85 who have hearing loss caused by damage to the inner ear.

Who else is applying?

What state do they live in?
North Carolina80.0%
South Carolina20.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Durham VA Medical Center, Durham, NC100.0%
What portion of applicants met pre-screening criteria?
Met criteria80.0%
Did not meet criteria20.0%
How many prior treatments have patients received?
0100.0%
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."

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.