Aging Clinical Trial
Official title:
Evaluating Hearing Aid Service Delivery Models
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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