Evaluating Hearing Aid Service Delivery Models
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Indiana University
- Enrollment
- 323
- Locations
- 2
- Primary Endpoint
- Profile of Hearing Aid Performance Benefit (PHAB)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 55 Years to 79 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
- •Exclusion Criteria : (for groups 1-4)
- •subject not interested in purchasing hearing aids
Arms & Interventions
Audiologist-Based
Audiologist selects hearing aid for patient
Intervention: hearing aid (Device)
Consumer Decides
Consumer selects hearing aid
Intervention: hearing aid (Device)
Placebo
Patient fitted with hearing aid that is acoustically transparent.
Intervention: hearing aid (Device)
Outcomes
Primary Outcomes
Profile of Hearing Aid Performance Benefit (PHAB)
Time Frame: 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 Outcomes
- Connected Speech Test (CST) Benefit(two times: at hearing-aid fit and at 6-weeks post-fit)
Investigators
Larry Humes
Distinguished Professor
Indiana University