Evaluation of Open-canal Behind-the-Ear Hearing Aids and Traditional In-the-ear Hearing Aids.
Evaluation of Open-Ear Canal and Traditional Custom-Fit Hearing Aids
1 other identifier
interventional
290
1 country
3
Brief Summary
This study is being conducted to evaluate the benefits of in-the-ear vs. open-fit behind-the-ear hearing aids. We want to learn more about which patients prefer each type, so we can make better choices about which type of hearing aid is best for which patients. Participants in this study will try three different sets of hearing aids for 2 months each, then we will evaluate the benefit of each type. Participants must be Veterans who are eligible for audiology care at one of the three participating sites.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2009
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 30, 2008
CompletedFirst Posted
Study publicly available on registry
August 4, 2008
CompletedStudy Start
First participant enrolled
May 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedResults Posted
Study results publicly available
June 3, 2014
CompletedJune 10, 2014
June 1, 2014
2.3 years
July 30, 2008
September 9, 2013
June 4, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants That Selected a Particular Type of Hearing Aid
At the end of the 6 month trial (after having worn each set of hearing aids for 2 months each)
Study Arms (1)
Hearing Aid Treatments
EXPERIMENTALHearing aid treatments: TC (Traditional Custom), RITA (Receiver-in-the Aid), and RITE (Receiver-in the-Ear)
Interventions
Hearing aid treatments: Traditional Custom (TC), Receiver-in-the Aid (RITA) and Receiver-in-the-Ear (RITE)
Eligibility Criteria
You may qualify if:
- Sensorineural hearing loss
- Veteran-adult onset of hearing
- English as first language
- Eligible for VA issued hearing aids
- Eligible to receive care at one of the three participating VA sites: Nashville, Tennessee, Mountain Home Tennessee, Bay Pines Florida
You may not qualify if:
- Known neurological, psychiatric disorders, or co-morbid disease that would prevent completion of the study
- Inadequate vision
- Inadequate reading skills
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- US Department of Veterans Affairslead
- Vanderbilt Universitycollaborator
Study Sites (3)
VA Medical Center, Bay Pines
Bay Pines, Florida, 33708, United States
James H. Quillen VA Medical Center
Mountain Home, Tennessee, 37684, United States
VA Medical Center
Nashville, Tennessee, 37212-2637, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
No limitations or caveats to report.
Results Point of Contact
- Title
- Gene W. Bratt, Ph.D.
- Organization
- VA TVHS
Study Officials
- PRINCIPAL INVESTIGATOR
Gene W. Bratt, PhD MA BA
VA Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 30, 2008
First Posted
August 4, 2008
Study Start
May 1, 2009
Primary Completion
September 1, 2011
Study Completion
September 1, 2011
Last Updated
June 10, 2014
Results First Posted
June 3, 2014
Record last verified: 2014-06