Evaluating Hearing Aid Service Delivery Models

Indiana University

Status: Completed

Conditions: Aging; Hearing Loss; Presbycusis

Treatments: Device: hearing aid

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01788423

1111007504

R01DC011771 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 323 patients

Sex: All

Ages: 55 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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323 participants in 3 patient groups, including a placebo group

Audiologist-Based

Experimental group

Description:

Audiologist selects hearing aid for patient

Treatment:

Device: hearing aid

Consumer Decides

Experimental group

Description:

Consumer selects hearing aid

Treatment:

Device: hearing aid

Placebo

Placebo Comparator group

Description:

Patient fitted with hearing aid that is acoustically transparent.

Treatment:

Device: hearing aid