Evaluating Hearing Aid Service Delivery Models

NCT ID: NCT01788423

Last Updated: 2019-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 323 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2018-02-28

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.

Conditions

Presbycusis; Aging; Hearing Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Audiologist-Based

Audiologist selects hearing aid for patient

Group Type: EXPERIMENTAL

hearing aid

Intervention Type: DEVICE

All subjects received hearing aids, some selected by audiologist, some selected by consumer, and some programmed as placebo devices.

Consumer Decides

Consumer selects hearing aid

Group Type: EXPERIMENTAL

hearing aid

Intervention Type: DEVICE

All subjects received hearing aids, some selected by audiologist, some selected by consumer, and some programmed as placebo devices.

Placebo

Patient fitted with hearing aid that is acoustically transparent.

Group Type: PLACEBO_COMPARATOR

hearing aid

Intervention Type: DEVICE

All subjects received hearing aids, some selected by audiologist, some selected by consumer, and some programmed as placebo devices.

Interventions

hearing aid

All subjects received hearing aids, some selected by audiologist, some selected by consumer, and some programmed as placebo devices.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 55-79 yrs of age
• Native English speaker
• no prior hearing aid use
• ability to read 18 point font

Exclusion Criteria

• 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

• subject not interested in purchasing hearing aids

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role: collaborator

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Larry Humes

Distinguished Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Larry E. Humes, PhD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

IU Department of Speech & Hearing Sciences

Bloomington, Indiana, United States

Countries

United States

References

Humes LE, Kinney DL, Main AK, Rogers SE. A Follow-Up Clinical Trial Evaluating the Consumer-Decides Service Delivery Model. Am J Audiol. 2019 Mar 15;28(1):69-84. doi: 10.1044/2018_AJA-18-0082.

Reference Type: DERIVED

PMID: 30938563 (View on PubMed)

Humes LE, Rogers SE, Quigley TM, Main AK, Kinney DL, Herring C. The Effects of Service-Delivery Model and Purchase Price on Hearing-Aid Outcomes in Older Adults: A Randomized Double-Blind Placebo-Controlled Clinical Trial. Am J Audiol. 2017 Mar 1;26(1):53-79. doi: 10.1044/2017_AJA-16-0111.

Reference Type: DERIVED

PMID: 28252160 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

R01DC011771

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1111007504

Identifier Type: -

Identifier Source: org_study_id