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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00727909
Recruitment Status : Completed
First Posted : August 4, 2008
Results First Posted : June 3, 2014
Last Update Posted : June 10, 2014
Vanderbilt University
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

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.

Condition or disease Intervention/treatment Phase
Hearing Loss Device: Hearing Aid Treatments Not Applicable

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  (Clinical Trial)
Actual Enrollment : 290 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Open-Ear Canal and Traditional Custom-Fit Hearing Aids
Study Start Date : May 2009
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hearing Aids

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)

Primary Outcome Measures :
  1. 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) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00727909

United States, Florida
VA Medical Center, Bay Pines
Bay Pines, Florida, United States, 33708
United States, Tennessee
James H. Quillen VA Medical Center
Mountain Home, Tennessee, United States, 37684
VA Medical Center
Nashville, Tennessee, United States, 37212-2637
Sponsors and Collaborators
US Department of Veterans Affairs
Vanderbilt University
Principal Investigator: Gene W. Bratt, PhD MA BA VA Medical Center

Responsible Party: US Department of Veterans Affairs Identifier: NCT00727909     History of Changes
Other Study ID Numbers: C6288-R
First Posted: August 4, 2008    Key Record Dates
Results First Posted: June 3, 2014
Last Update Posted: June 10, 2014
Last Verified: June 2014

Keywords provided by VA Office of Research and Development ( US Department of Veterans Affairs ):
Hearing loss
Hearing Aids
Speech Perception
Persons with Hearing Impairment

Additional relevant MeSH terms:
Hearing Loss
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms