NCT01788423

Evaluating Hearing Aid Service Delivery Models

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 323 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 55 Years – 79 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Presbycusis
• Aging
• Hearing Loss

Interventions

Type	Name	Description
DEVICE	hearing aid	All subjects received hearing aids, some selected by audiologist, some selected by consumer, and some programmed as placebo devices.

Timeline

• Start date: 2012-11-01
• Primary completion: 2018-02-28
• Completion: 2018-02-28
• First posted: 2013-02-11
• Last updated: 2019-07-23
• Results posted: 2019-07-23

Locations

1 site across 1 country: United States