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

NCT ID: NCT00727909

Last Updated: 2014-06-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 290 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2011-09-30

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.

Conditions

Hearing Loss

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hearing Aid Treatments

Hearing aid treatments:

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

Group Type: EXPERIMENTAL

Hearing Aid Treatments

Intervention Type: DEVICE

Hearing aid treatments:

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

Interventions

Hearing Aid Treatments

Hearing aid treatments:

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University

OTHER

Sponsor Role: collaborator

US Department of Veterans Affairs

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gene W. Bratt, PhD MA BA

Role: PRINCIPAL_INVESTIGATOR

VA Medical Center

Locations

VA Medical Center, Bay Pines

Bay Pines, Florida, United States

James H. Quillen VA Medical Center

Mountain Home, Tennessee, United States

VA Medical Center

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

C6288-R

Identifier Type: -

Identifier Source: org_study_id