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View Clinical Trial (Medical Research Study)
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Evaluation of Open-canal Behind-the-Ear Hearing Aids and Traditional In-the-ear Hearing Aids. - NCT00727909-33708 (Clinical Trial 234711)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy234711.aspx
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| City: |
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Bay Pines |
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State:
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FL |
| Zip Code: |
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33708 |
| Conditions: |
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Hearing Loss |
| Purpose: |
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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.
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| Study summary: |
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Hearing loss is the most common service-connected disability nationwide in the 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" eartip. 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. |
| Criteria: |
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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,
Mountain Home TN, Bay Pines FL
Exclusion Criteria:
- Known neurological, psychiatric disorders, or co-morbid disease that would prevent
completion of the study
- Inadequate vision
- Inadequate reading skills |
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| Study is available at: |
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VA Medical Center, Bay Pines
Bay Pines, FL 33708
United States
Primary Contact:
Rachel A McArdle, PhD
Email: rachel.mcardle@va.gov
Phone: 727-398-6661
Secondary Contact:
Mia A Rosenfeld, PhD MS BA
Email: mia.rosenfeld@va.gov
Phone: (615) 873-8572 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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