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

June 4, 2014 updated by: US Department of Veterans Affairs

Evaluation of Open-Ear Canal and Traditional Custom-Fit Hearing Aids

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

290

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Bay Pines, Florida, United States, 33708
        • VA Medical Center, Bay Pines
    • Tennessee
      • Mountain Home, Tennessee, United States, 37684
        • James H. Quillen VA Medical Center
      • Nashville, Tennessee, United States, 37212-2637
        • VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hearing Aid Treatments

Hearing aid treatments:

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

Hearing aid treatments:

Traditional Custom (TC), Receiver-in-the Aid (RITA) and Receiver-in-the-Ear (RITE)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
At the end of the 6 month trial (after having worn each set of hearing aids for 2 months each)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

US Department of Veterans Affairs

Collaborators

Vanderbilt University

Investigators

  • Principal Investigator: Gene W. Bratt, PhD MA BA, VA Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

July 30, 2008

First Submitted That Met QC Criteria

July 30, 2008

First Posted (Estimate)

August 4, 2008

Study Record Updates

Last Update Posted (Estimate)

June 10, 2014

Last Update Submitted That Met QC Criteria

June 4, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C6288-R

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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