Evaluating Hearing Aid Service Delivery Models

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.

Study Overview

• Status: Completed
• Conditions: Aging; Hearing Loss; Presbycusis
• Intervention / Treatment: Device: hearing aid

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.

• Study Type: Interventional
• Enrollment (Actual): 323
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Bloomington, Indiana, United States, 47405-7002
      • IU Department of Speech & Hearing Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Audiologist-Based; Audiologist selects hearing aid for patient	Device: hearing aid; All subjects received hearing aids, some selected by audiologist, some selected by consumer, and some programmed as placebo devices.
Experimental: Consumer Decides; Consumer selects hearing aid	Device: hearing aid; All subjects received hearing aids, some selected by audiologist, some selected by consumer, and some programmed as placebo devices.
Placebo Comparator: Placebo; Patient fitted with hearing aid that is acoustically transparent.	Device: hearing aid; All subjects received hearing aids, some selected by audiologist, some selected by consumer, and some programmed as placebo devices.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD)
• Investigators: Principal Investigator: Larry E. Humes, PhD, Indiana University

Publications and helpful links

General Publications

• 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. Erratum In: Am J Audiol. 2019 Sep 13;28(3):730.
• 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. Erratum In: Am J Audiol. 2019 Sep 13;28(3):730.

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): February 28, 2018
• Study Completion (Actual): February 28, 2018

Study Registration Dates

• First Submitted: October 24, 2012
• First Submitted That Met QC Criteria: February 7, 2013
• First Posted (Estimate): February 11, 2013

Study Record Updates

• Last Update Posted (Actual): July 23, 2019
• Last Update Submitted That Met QC Criteria: July 3, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: hearing aids; presbycusis
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss, Sensorineural; Hearing Loss; Presbycusis
• Other Study ID Numbers: 1111007504; R01DC011771 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Study protocol, study forms, and final publication all available via Open Access publication in the American Journal of Audiology in March, 2017. De-identified individual data available from PI upon request.
• IPD Sharing Time Frame: Already available online with Open Access publication of the study in March, 2017.
• IPD Sharing Access Criteria: Open Access to protocol, study forms, and detailed results via publication in March, 2017. De-identified data available from investigator upon request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF