Clinical trial NCT01788423: Evaluating Hearing Aid Service Delivery Models
Official title: Evaluating Hearing Aid Service Delivery Models
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Presbycusis
Aging
Hearing Loss
Keywords: presbycusis
hearing aids
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2013-02-11
Enrollment: 323
Sex: ALL
Minimum age (years): 55
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Profile of Hearing Aid Performance Benefit (PHAB)
timeFrame: two times: at hearing-aid fit and at 6-weeks post-fit
Secondary outcomes:
measure: Connected Speech Test (CST) Benefit
timeFrame: two times: at hearing-aid fit and at 6-weeks post-fit
Other outcomes:
Locations:
city: Bloomington
country: United States
facility: IU Department of Speech & Hearing Sciences
state: Indiana
Study officials:
affiliation: Indiana University
name: Larry E. Humes, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.