Aging, Hearing Loss, Presbycusis
Conditions
Keywords
presbycusis, hearing aids
Brief summary
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.
Detailed description
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.
Interventions
DEVICEhearing aid
All subjects received hearing aids, some selected by audiologist, some selected by consumer, and some programmed as placebo devices.
Sponsors
National Institute on Deafness and Other Communication Disorders (NIDCD)
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
55 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
(for groups 1-4) * 55-79 yrs of age * Native English speaker * no prior hearing aid use * ability to read 18 point font
Exclusion criteria
(for groups 1-3) * hearing loss too severe or too mild for hearing aid * middle-ear conductive pathology present * asymmetrical hearing loss * presence of dementia, Parkinson's disease, or other neurological disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Profile of Hearing Aid Performance Benefit (PHAB) | two times: at hearing-aid fit and at 6-weeks post-fit | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Connected Speech Test (CST) Benefit | two times: at hearing-aid fit and at 6-weeks post-fit | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 53 |
| 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. | 51 |
| 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. | 50 |
| Total | 154 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | See Comments in Completed (above) | 0 | 4 | 5 |
Baseline characteristics
| Characteristic | Audiologist-Based | Total | Placebo | Consumer Decides |
|---|---|---|---|---|
| Age, Continuous | 69.9 years STANDARD_DEVIATION 5.6 | 69.1 years STANDARD_DEVIATION 6 | 69.5 years STANDARD_DEVIATION 6.7 | 68.0 years STANDARD_DEVIATION 6.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 52 Participants | 152 Participants | 50 Participants | 50 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 3 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 52 Participants | 149 Participants | 47 Participants | 50 Participants |
| Region of Enrollment United States | 53 Participants | 154 Participants | 50 Participants | 51 Participants |
| Sex: Female, Male Female | 25 Participants | 67 Participants | 16 Participants | 26 Participants |
| Sex: Female, Male Male | 28 Participants | 87 Participants | 34 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 53 | 0 / 51 | 0 / 50 |
| other Total, other adverse events | 0 / 53 | 0 / 51 | 0 / 50 |
| serious Total, serious adverse events | 0 / 53 | 0 / 51 | 0 / 50 |
Outcome results
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).
Time frame: two times: at hearing-aid fit and at 6-weeks post-fit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Audiologist-Based | Profile of Hearing Aid Performance Benefit (PHAB) | 0.17 Proportion of time had difficulties | Standard Deviation 0.12 |
| Consumer Decides | Profile of Hearing Aid Performance Benefit (PHAB) | 0.12 Proportion of time had difficulties | Standard Deviation 0.12 |
| Placebo | Profile of Hearing Aid Performance Benefit (PHAB) | 0.04 Proportion of time had difficulties | Standard Deviation 0.1 |
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.
Time frame: two times: at hearing-aid fit and at 6-weeks post-fit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Audiologist-Based | Connected Speech Test (CST) Benefit | 21.3 Percentage of keywords correct | Standard Deviation 19.4 |
| Consumer Decides | Connected Speech Test (CST) Benefit | 26.6 Percentage of keywords correct | Standard Deviation 16.1 |
| Placebo | Connected Speech Test (CST) Benefit | 8.7 Percentage of keywords correct | Standard Deviation 21.2 |