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Evaluation of Open-canal Behind-the-Ear Hearing Aids and Traditional In-the-ear Hearing Aids.

Primary Purpose

Hearing Loss

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hearing Aid Treatments
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hearing Loss focused on measuring Hearing loss, Hearing Aids, Speech Perception, Persons with Hearing Impairment

Eligibility Criteria

21 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Known neurological, psychiatric disorders, or co-morbid disease that would prevent completion of the study
  • Inadequate vision
  • Inadequate reading skills

Sites / Locations

  • VA Medical Center, Bay Pines
  • James H. Quillen VA Medical Center
  • VA Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hearing Aid Treatments

Arm Description

Hearing aid treatments: TC (Traditional Custom), RITA (Receiver-in-the Aid), and RITE (Receiver-in the-Ear)

Outcomes

Primary Outcome Measures

Percentage of Participants That Selected a Particular Type of Hearing Aid

Secondary Outcome Measures

Full Information

First Posted
July 30, 2008
Last Updated
June 4, 2014
Sponsor
US Department of Veterans Affairs
Collaborators
Vanderbilt University
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1. Study Identification

Unique Protocol Identification Number
NCT00727909
Brief Title
Evaluation of Open-canal Behind-the-Ear Hearing Aids and Traditional In-the-ear Hearing Aids.
Official Title
Evaluation of Open-Ear Canal and Traditional Custom-Fit Hearing Aids
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs
Collaborators
Vanderbilt University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Hearing loss is the most common service-connected disability nationwide in the Veteran's Health Administration (VHA) system, with hearing aids providing the primary treatment option. Although the benefits of hearing-aid use are clearly established,~16-30% of adults who have hearing aids do not use them. Several factors are believed to result in non-use of traditional hearing aids, including (1) poor fit and comfort, (2) poor cosmetics, (3) whistling feedback, (4) occlusion, and (5) difficulty understanding speech in noise. Recently, the open canal (OC) hearing-aid style has become a viable approach to addressing address many of the problems resulting in non-use of traditional hearing aids, particularly for individuals with mild to moderately-severe hearing loss. Although an OC hearing aid has many potential advantages, there also are potential limitations. For example, the maximum low and high-frequency gain available with an OC fitting is less than that available from traditional custom (TC) hearing-aid fittings, which could result in less than optimal amplification for some individuals. In addition, directional microphone benefits for speech understanding in noise, available with TC fittings, likely will be limited with OC fittings due to the loss of low-frequency gain (Ricketts et al., 2005). Since both OC and TC fittings are appropriate for listeners with mild to moderately-severe hearing losses, evidence is needed to determine which style of hearing aid is preferred by a majority. Currently, OC fittings use a small behind-the-ear (BTE) hearing aid coupled to a thin tube or plastic covered wire ending in a vented "open" ear tip. When a TC fitting is used with patients with similar hearing losses, the majority are either an in-the-ear (ITE) or in-the-canal (ITC) .In the proposed study a comparison will be made between OC vs. TC fittings. In addition to this primary comparison, preference for one of two OC hearing aids, viz., OC instruments with receiver in the ear (OCRITE) and the OC instruments with receiver in the hearing-aid case (OCRIHA), will be determined. The outcomes of the OCRITE, OCRIHA, and TC hearing-aid use related to the factors of: (1) comfort and cosmetics, (2) subjective occlusion, (3) objective occlusion, (4) sound quality for external sounds, (5) feedback, (6) ease of use, (7) audibility, (8) aided signal-to-noise ratio (SNR) benefit, and (9) localization, will be measured in a large (n = 288), randomized-controlled, three-site (Bay Pines, Mountain Home, and Nashville) clinical trial, utilizing a three-period (two months each), cross-over design. A total of 13 variables will be measured for the 9 hearing-aid fitting and style-related factors. At the end of the study, participants will rank order their preferences for the three hearing aid fittings to determine (1) the preferred OC fitting (OCRITE vs. OCRIHA) and (2) whether the highest ranked OC fitting or the TC fitting is preferred. Preferred OC vs. TC difference scores will be calculated for all relevant variables. The ability of the differences scores to predict the preferences of the participants for an OC vs. TC hearing aid will be determined, in order to develop an evidence-based hearing aid selection model.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss
Keywords
Hearing loss, Hearing Aids, Speech Perception, Persons with Hearing Impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
290 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hearing Aid Treatments
Arm Type
Experimental
Arm Description
Hearing aid treatments: TC (Traditional Custom), RITA (Receiver-in-the Aid), and RITE (Receiver-in the-Ear)
Intervention Type
Device
Intervention Name(s)
Hearing Aid Treatments
Intervention Description
Hearing aid treatments: Traditional Custom (TC), Receiver-in-the Aid (RITA) and Receiver-in-the-Ear (RITE)
Primary Outcome Measure Information:
Title
Percentage of Participants That Selected a Particular Type of Hearing Aid
Time Frame
At the end of the 6 month trial (after having worn each set of hearing aids for 2 months each)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Known neurological, psychiatric disorders, or co-morbid disease that would prevent completion of the study Inadequate vision Inadequate reading skills
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gene W. Bratt, PhD MA BA
Organizational Affiliation
VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Medical Center, Bay Pines
City
Bay Pines
State/Province
Florida
ZIP/Postal Code
33708
Country
United States
Facility Name
James H. Quillen VA Medical Center
City
Mountain Home
State/Province
Tennessee
ZIP/Postal Code
37684
Country
United States
Facility Name
VA Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212-2637
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Evaluation of Open-canal Behind-the-Ear Hearing Aids and Traditional In-the-ear Hearing Aids.

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