Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Vanderbilt University | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hearing Aid Treatments | Experimental | Hearing aid treatments: TC (Traditional Custom), RITA (Receiver-in-the Aid), and RITE (Receiver-in the-Ear) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hearing Aid Treatments | Device | Hearing aid treatments: Traditional Custom (TC), Receiver-in-the Aid (RITA) and Receiver-in-the-Ear (RITE) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants That Selected a Particular Type of Hearing Aid | At the end of the 6 month trial (after having worn each set of hearing aids for 2 months each) |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Gene W. Bratt, PhD MA BA | VA Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Medical Center, Bay Pines | Bay Pines | Florida | 33708 | United States | ||
| James H. Quillen VA Medical Center |
All study participants were assigned into all three hearing aid treatments: Traditional Custom TC, Receiver-in-the Aid (RITA), Receiver-in-the-Ear (RITE). The sequence of treatments was counter-balanced to prevent an order effect.
Eleven participants who consented withdrew or were excluded prior to the first condition hearing aid fitting.
Participants were recruited from Veterans scheduled for audiology appointments at the three participating VA sites: Nashville, Tennessee, Bay Pines, Florida, and Mountain Home, Tennessee. Recruitment occurred during the time period May, 2009 through February, 2011.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | TC RITE RITA | Participants received Traditional Custom hearing aid (TC) first, followed by Receiver in the Ear (RITE), followed by Receiver in the Aid (RITA). The length of each hearing aid treatment condition was 2 months. |
| FG001 | TC RITA RITE | Participants received Traditional Custom hearing aid (TC) first, followed by Receiver in the Aid (RITA), followed by Receiver in the Ear (RITE). The length of each hearing aid treatment condition was 2 months. |
| FG002 | RITE RITA TC | Participants received the Receiver in the Ear (RITE) hearing aid first, followed by Receiver in the Aid (RITA), followed by Traditional Custom hearing aid (TC). The length of each hearing aid treatment condition was 2 months. |
| FG003 | RITA RITE TC | Participants received the Receiver in the Aid (RITA) hearing aid first, followed by Receiver in the Ear (RITE), followed by Traditional Custom (TC). The length of each hearing aid treatment condition was 2 months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All Study Participants
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | All study participants received all three hearing aid treatments (TC, RITA, RITE). The sequence of treatments was counter-balanced to prevent an order effect. Each hearing aid treatment lasted two months. Each treatment period was followed by the administration of a series of outcome measures before the next treatment was begun. At the conclusion of the third treatment, in addition to administration of the outcome measures, the participants were asked to rank the three hearing aid treatments in order of preference, and to provide subjective comments regarding the rationale for their rank-ordering. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants That Selected a Particular Type of Hearing Aid | Posted | Number | percentage of participants | At the end of the 6 month trial (after having worn each set of hearing aids for 2 months each) |
|
|
1 year, 10 months.
The investigators at all 3 VA sites conducted their roles in this investigation under the purview of the local Institutional Review Board(IRB) at each site. The investigators, through their mandatory training, were fully cognizant of the significance of and procedures for reporting any adverse event that could have but did not occur.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Study Participants | All participants received all three hearing aid treatments. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Congestive heart failure | Cardiac disorders | Non-systematic Assessment | Participant at Bay Pines died of congestive heart failure following hospitalization for hip fracture/hip surgery while enrolled in this study and in receipt of the second hearing aid intervention (RITA).The death was unrelated to study participation. |
Not provided
No limitations or caveats to report.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gene W. Bratt, Ph.D. | VA TVHS | 615-873-6068 | gene.bratt@va.gov |
Not provided
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Mountain Home |
| Tennessee |
| 37684 |
| United States |
| VA Medical Center | Nashville | Tennessee | 37212-2637 | United States |
| Death |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 1 |
| 290 |
| 0 |
| 290 |
|
Not provided
Not provided
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |