Hearing Loss
Conditions
Keywords
Hearing loss, Hearing Aids, Speech Perception, Persons with Hearing Impairment
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.
Interventions
DEVICEHearing Aid Treatments
Hearing aid treatments: Traditional Custom (TC), Receiver-in-the Aid (RITA) and Receiver-in-the-Ear (RITE)
Sponsors
Vanderbilt University
US Department of Veterans Affairs
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 85 Years
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
Design outcomes
Primary
| Measure | 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) |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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 by arm
| Arm | Count |
|---|---|
| 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. | 290 |
| Total | 290 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death | 0 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 5 | 11 | 8 | 5 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 184 Participants |
| Age, Categorical Between 18 and 65 years | 106 Participants |
| Age, Continuous | 67.9 years STANDARD_DEVIATION 9.4 |
| Region of Enrollment United States | 290 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 283 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 290 |
| serious Total, serious adverse events | 1 / 290 |
Outcome results
Primary
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)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants | Percentage of Participants That Selected a Particular Type of Hearing Aid | Percentage of participants preferring TC | 15 percentage of participants |
| All Participants | Percentage of Participants That Selected a Particular Type of Hearing Aid | Percentage of participants preferring RITE | 38 percentage of participants |
| All Participants | Percentage of Participants That Selected a Particular Type of Hearing Aid | Percentage of participants preferring RITA | 47 percentage of participants |