Evaluating Hearing Aid Service Delivery Models

Aging Clinical Trial

Official title:

Evaluating Hearing Aid Service Delivery Models

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01788423
• Other study ID #: 1111007504
• Secondary ID: R01DC011771
• Status: Completed
• Phase: N/A
• Start date: November 2012
• Est. completion date: February 28, 2018

Study information

• Verified date: July 2019
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 323
• Est. completion date: February 28, 2018
• Est. primary completion date: February 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Aging
• Hearing Loss
• Presbycusis

Intervention

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

Locations

Country	Name	City	State
United States	IU Department of Speech & Hearing Sciences	Bloomington	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	National Institute on Deafness and Other Communication Disorders (NIDCD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Profile of Hearing Aid Performance Benefit (PHAB)	Change from unaided to aided performance on the Profile of Hearing Aid Performance with the difference in aided and unaided scores labeled Profile of Hearing Aid Benefit (PHAB), a self-report measure of benefit. The aided and unaided PHAP scores are proportions of time difficulties encountered in various listening situations. Low PHAP scores indicate less frequent difficulties. When subtracting aided from unaided PHAP scores, a positive PHAB score reflects less frequent problems when wearing a hearing aid compared to without. The range of possible PHAB scores are -1.0 to +1.0 with 0.0 indicating no difference between aided and unaided performance.; There are seven subscales of the PHAP/PHAB and the scores reported are based on the arithmetic means of the five subscales that deal with speech communication, PHABglobal. These include the following subscale scores: EC (Ease of Communication), FT (Familiar Talkers), BN (Background Noise), Reverberation (RV) and Reduced Cues (RC).	two times: at hearing-aid fit and at 6-weeks post-fit
Secondary	Connected Speech Test (CST) Benefit	A standardized speech-perception test, based on meaningful sentences and keyword scoring, the Connected Speech Test (CST) was administered unaided and aided. Each CST score represents the percentage of keywords (out of 50) repeated correctly following presentation via loudspeakers. Scores can range from 0 to 100% correct with higher scores indicating better speech perception. For the CST benefit scores reported below, unaided CST scores are subtracted from aided scores such that positive values represent better performance for aided than unaided listening. The possible range of CST benefit scores is -100 to +100 with 0 representing no difference between unaided and aided speech-perception performance.	two times: at hearing-aid fit and at 6-weeks post-fit