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| ID | Type | Description | Link |
|---|---|---|---|
| R01DC011771 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Deafness and Other Communication Disorders (NIDCD) | NIH |
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The purpose of this study is to compare the outcomes for two different hearing-aid delivery models. In one model, the audiologist selects and fits the hearing aid and, in the other model, the consumer does this directly.
The objectives of this study were to determine efficacy of hearing aids in older adults using audiology best practices, to evaluate the efficacy of an alternative over-the-counter (OTC) intervention, and to examine the influence of purchase price on outcomes for both service-delivery models. The design of this study was a single-site, prospective, double-blind placebo-controlled randomized trial with three parallel branches: (a) audiology best practices (AB), (b) consumer decides OTC model (CD), and (c) placebo devices (P). Outcome measures were obtained after a typical 6-week trial period with follow-up 4-week AB-based trial for those initially assigned to CD and P groups.
Older adults from the general community were recruited via newspaper and community flyers to participate at a university research clinic. Participants were adults, ages 55-79 years,with mild-to-moderate hearing loss. Intervention(s): All participants received the same highenddigital mini-behind-the-ear hearing aids fitted bilaterally.AB and P groups received best-practice services from audiologists; differing mainly in use of appropriate (AB) or placebo (P) hearing aid settings. CD participants self-selected their own pre-programmed hearing aids via an OTC model. Primary outcome measure was a 66-item self-report, Profile of Hearing Aid Performance/Benefit. Secondary outcome measure was the Connected Speech Test benefit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Audiologist-Based | Experimental | Audiologist selects hearing aid for patient |
|
| Consumer Decides | Experimental | Consumer selects hearing aid |
|
| Placebo | Placebo Comparator | Patient fitted with hearing aid that is acoustically transparent. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hearing aid | Device | All subjects received hearing aids, some selected by audiologist, some selected by consumer, and some programmed as placebo devices. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Profile of Hearing Aid Performance Benefit (PHAB) | Change from unaided to aided performance on the Profile of Hearing Aid Performance with the difference in aided and unaided scores labeled Profile of Hearing Aid Benefit (PHAB), a self-report measure of benefit. The aided and unaided PHAP scores are proportions of time difficulties encountered in various listening situations. Low PHAP scores indicate less frequent difficulties. When subtracting aided from unaided PHAP scores, a positive PHAB score reflects less frequent problems when wearing a hearing aid compared to without. The range of possible PHAB scores are -1.0 to +1.0 with 0.0 indicating no difference between aided and unaided performance. There are seven subscales of the PHAP/PHAB and the scores reported are based on the arithmetic means of the five subscales that deal with speech communication, PHABglobal. These include the following subscale scores: EC (Ease of Communication), FT (Familiar Talkers), BN (Background Noise), Reverberation (RV) and Reduced Cues (RC). | two times: at hearing-aid fit and at 6-weeks post-fit |
| Measure | Description | Time Frame |
|---|---|---|
| Connected Speech Test (CST) Benefit | A standardized speech-perception test, based on meaningful sentences and keyword scoring, the Connected Speech Test (CST) was administered unaided and aided. Each CST score represents the percentage of keywords (out of 50) repeated correctly following presentation via loudspeakers. Scores can range from 0 to 100% correct with higher scores indicating better speech perception. For the CST benefit scores reported below, unaided CST scores are subtracted from aided scores such that positive values represent better performance for aided than unaided listening. The possible range of CST benefit scores is -100 to +100 with 0 representing no difference between unaided and aided speech-perception performance. |
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Inclusion Criteria: (for groups 1-4)
Exclusion Criteria: (for groups 1-3)
Exclusion Criteria : (for groups 1-4)
- subject not interested in purchasing hearing aids
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| Name | Affiliation | Role |
|---|---|---|
| Larry E. Humes, PhD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IU Department of Speech & Hearing Sciences | Bloomington | Indiana | 47405-7002 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30938563 | Derived | Humes LE, Kinney DL, Main AK, Rogers SE. A Follow-Up Clinical Trial Evaluating the Consumer-Decides Service Delivery Model. Am J Audiol. 2019 Mar 15;28(1):69-84. doi: 10.1044/2018_AJA-18-0082. | |
| 28252160 | Derived | Humes LE, Rogers SE, Quigley TM, Main AK, Kinney DL, Herring C. The Effects of Service-Delivery Model and Purchase Price on Hearing-Aid Outcomes in Older Adults: A Randomized Double-Blind Placebo-Controlled Clinical Trial. Am J Audiol. 2017 Mar 1;26(1):53-79. doi: 10.1044/2017_AJA-16-0111. |
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Study protocol, study forms, and final publication all available via Open Access publication in the American Journal of Audiology in March, 2017. De-identified individual data available from PI upon request.
Already available online with Open Access publication of the study in March, 2017.
Open Access to protocol, study forms, and detailed results via publication in March, 2017. De-identified data available from investigator upon request.
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Of the 323 participants enrolled for assessment of eligibility, 135 were excluded because they did not meet inclusion criteria and 25 declined to participate, leaving 163 to be randomly allocated to one of the three intervention groups.
The trial commenced November 2, 2012, and data collection ended August 31, 2016. Participants were recruited primarily by ads posted in the local newspapers and around the community. All testing of this volunteer sample took place in a university research clinic at Indiana University, Bloomington.
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| ID | Title | Description |
|---|---|---|
| FG000 | Audiologist-Based | Audiologist selects hearing aid for patient hearing aid: All subjects received hearing aids, some selected by audiologist, some selected by consumer, and some programmed as placebo devices. |
| FG001 | Consumer Decides | Consumer selects hearing aid hearing aid: All subjects received hearing aids, some selected by audiologist, some selected by consumer, and some programmed as placebo devices. |
| FG002 | Placebo | Patient fitted with hearing aid that is acoustically transparent. hearing aid: All subjects received hearing aids, some selected by audiologist, some selected by consumer, and some programmed as placebo devices. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Audiologist-Based | Audiologist selects hearing aid for patient hearing aid: All subjects received hearing aids, some selected by audiologist, some selected by consumer, and some programmed as placebo devices. |
| BG001 | Consumer Decides |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Profile of Hearing Aid Performance Benefit (PHAB) | Change from unaided to aided performance on the Profile of Hearing Aid Performance with the difference in aided and unaided scores labeled Profile of Hearing Aid Benefit (PHAB), a self-report measure of benefit. The aided and unaided PHAP scores are proportions of time difficulties encountered in various listening situations. Low PHAP scores indicate less frequent difficulties. When subtracting aided from unaided PHAP scores, a positive PHAB score reflects less frequent problems when wearing a hearing aid compared to without. The range of possible PHAB scores are -1.0 to +1.0 with 0.0 indicating no difference between aided and unaided performance. There are seven subscales of the PHAP/PHAB and the scores reported are based on the arithmetic means of the five subscales that deal with speech communication, PHABglobal. These include the following subscale scores: EC (Ease of Communication), FT (Familiar Talkers), BN (Background Noise), Reverberation (RV) and Reduced Cues (RC). | Posted | Mean | Standard Deviation | Proportion of time had difficulties | two times: at hearing-aid fit and at 6-weeks post-fit |
|
46 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Audiologist-Based | Audiologist selects hearing aid for patient hearing aid: All subjects received hearing aids, some selected by audiologist, some selected by consumer, and some programmed as placebo devices. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Larry E. Humes | Indiana University, Department of Speech and Hearing Sci | 812-855-3507 | humes@indiana.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 2, 2012 | May 16, 2019 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D011304 | Presbycusis |
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D006319 | Hearing Loss, Sensorineural |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D006310 | Hearing Aids |
| ID | Term |
|---|---|
| D000076251 | Wearable Electronic Devices |
| D055615 | Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
| D012682 | Sensory Aids |
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| two times: at hearing-aid fit and at 6-weeks post-fit |
Consumer selects hearing aid hearing aid: All subjects received hearing aids, some selected by audiologist, some selected by consumer, and some programmed as placebo devices. |
| BG002 | Placebo | Patient fitted with hearing aid that is acoustically transparent. hearing aid: All subjects received hearing aids, some selected by audiologist, some selected by consumer, and some programmed as placebo devices. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Midwestern United States based on residence reported. | Count of Participants | Participants |
|
| OG000 | Audiologist-Based | Audiologist selects hearing aid for patient hearing aid: All subjects received hearing aids, some selected by audiologist, some selected by consumer, and some programmed as placebo devices. |
| OG001 | Consumer Decides | Consumer selects hearing aid hearing aid: All subjects received hearing aids, some selected by audiologist, some selected by consumer, and some programmed as placebo devices. |
| OG002 | Placebo | Patient fitted with hearing aid that is acoustically transparent. hearing aid: All subjects received hearing aids, some selected by audiologist, some selected by consumer, and some programmed as placebo devices. |
|
|
| Secondary | Connected Speech Test (CST) Benefit | A standardized speech-perception test, based on meaningful sentences and keyword scoring, the Connected Speech Test (CST) was administered unaided and aided. Each CST score represents the percentage of keywords (out of 50) repeated correctly following presentation via loudspeakers. Scores can range from 0 to 100% correct with higher scores indicating better speech perception. For the CST benefit scores reported below, unaided CST scores are subtracted from aided scores such that positive values represent better performance for aided than unaided listening. The possible range of CST benefit scores is -100 to +100 with 0 representing no difference between unaided and aided speech-perception performance. | Posted | Mean | Standard Deviation | Percentage of keywords correct | two times: at hearing-aid fit and at 6-weeks post-fit |
|
|
|
| 0 |
| 53 |
| 0 |
| 53 |
| 0 |
| 53 |
| EG001 | Consumer Decides | Consumer selects hearing aid hearing aid: All subjects received hearing aids, some selected by audiologist, some selected by consumer, and some programmed as placebo devices. | 0 | 51 | 0 | 51 | 0 | 51 |
| EG002 | Placebo | Patient fitted with hearing aid that is acoustically transparent. hearing aid: All subjects received hearing aids, some selected by audiologist, some selected by consumer, and some programmed as placebo devices. | 0 | 50 | 0 | 50 | 0 | 50 |
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| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |