Evaluating Hearing Aid Service Delivery Models

• Sponsor: Indiana University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01788423
• Collaborator: National Institute on Deafness and Other Communication Disorders (NIDCD) (NIH)
• Enrollment: 323
• Location: 1
• Arms: 3
• Duration (Months): 63.9
• Patients Per Site Per Month: 5.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Presbycusis; Aging; Hearing Loss	Device: hearing aid	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 323 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Evaluating Hearing Aid Service Delivery Models
• Study Start Date: Nov 1, 2012
• Actual Primary Completion Date: Feb 28, 2018
• Actual Study Completion Date: Feb 28, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Profile of Hearing Aid Performance Benefit (PHAB) [two times: at hearing-aid fit and at 6-weeks post-fit]

   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).

Secondary Outcome Measures

1. Connected Speech Test (CST) Benefit [two times: at hearing-aid fit and at 6-weeks post-fit]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 55 Years to 79 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	IU Department of Speech & Hearing Sciences	Bloomington	Indiana	United States	47405-7002

Sponsors and Collaborators

• Indiana University
• National Institute on Deafness and Other Communication Disorders (NIDCD)

Investigators

• Principal Investigator: Larry E. Humes, PhD, Indiana University

Study Documents (Full-Text)

• Study Protocol - Nov 2, 2012

More Information

Publications

None provided.

• Responsible Party: Larry Humes, Distinguished Professor, Indiana University
• ClinicalTrials.gov Identifier: NCT01788423
• Other Study ID Numbers: 1111007504; R01DC011771
• First Posted: Feb 11, 2013
• Last Update Posted: Jul 23, 2019
• Last Verified: Jul 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Larry Humes, Distinguished Professor, Indiana University: presbycusis; hearing aids
• Additional relevant MeSH terms: Hearing Loss; Presbycusis

Study Results

Participant Flow

Recruitment Details	The trial commenced November 2, 2012, and data collection ended August 31, 2016. Participants were recruited primarily by ads posted in the local newspapers and around the community. All testing of this volunteer sample took place in a university research clinic at Indiana University, Bloomington.
Pre-assignment Detail	Of the 323 participants enrolled for assessment of eligibility, 135 were excluded because they did not meet inclusion criteria and 25 declined to participate, leaving 163 to be randomly allocated to one of the three intervention groups.

Arm/Group Title	Audiologist-Based	Consumer Decides	Placebo
Arm/Group Description	Audiologist selects hearing aid for patient hearing aid: All subjects received hearing aids, some selected by audiologist, some selected by consumer, and some programmed as placebo devices.	Consumer selects hearing aid hearing aid: All subjects received hearing aids, some selected by audiologist, some selected by consumer, and some programmed as placebo devices.	Patient fitted with hearing aid that is acoustically transparent. hearing aid: All subjects received hearing aids, some selected by audiologist, some selected by consumer, and some programmed as placebo devices.
Period Title: Overall Study
STARTED	53	55	55
COMPLETED	53	51	50
NOT COMPLETED	0	4	5

Baseline Characteristics

Arm/Group Title	Audiologist-Based	Consumer Decides	Placebo	Total
Arm/Group Description	Audiologist selects hearing aid for patient hearing aid: All subjects received hearing aids, some selected by audiologist, some selected by consumer, and some programmed as placebo devices.	Consumer selects hearing aid hearing aid: All subjects received hearing aids, some selected by audiologist, some selected by consumer, and some programmed as placebo devices.	Patient fitted with hearing aid that is acoustically transparent. hearing aid: All subjects received hearing aids, some selected by audiologist, some selected by consumer, and some programmed as placebo devices.	Total of all reporting groups
Overall Participants	53	51	50	154
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	69.9 (5.6)	68.0 (6.2)	69.5 (6.7)	69.1 (6.0)
Sex: Female, Male (Count of Participants)
Female	25 47.2%	26 51%	16 32%	67 43.5%
Male	28 52.8%	25 49%	34 68%	87 56.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 1.9%	1 2%	0 0%	2 1.3%
Not Hispanic or Latino	52 98.1%	50 98%	50 100%	152 98.7%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	1 2%	2 4%	3 1.9%
Asian	1 1.9%	0 0%	0 0%	1 0.6%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%	0 0%
White	52 98.1%	50 98%	47 94%	149 96.8%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	1 2%	1 0.6%
Region of Enrollment (Count of Participants)
United States	53 100%	51 100%	50 100%	154 100%

Outcome Measures

1. Primary Outcome

Title	Profile of Hearing Aid Performance Benefit (PHAB)
Description	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).
Time Frame	two times: at hearing-aid fit and at 6-weeks post-fit

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Audiologist-Based	Consumer Decides	Placebo
Arm/Group Description	Audiologist selects hearing aid for patient hearing aid: All subjects received hearing aids, some selected by audiologist, some selected by consumer, and some programmed as placebo devices.	Consumer selects hearing aid hearing aid: All subjects received hearing aids, some selected by audiologist, some selected by consumer, and some programmed as placebo devices.	Patient fitted with hearing aid that is acoustically transparent. hearing aid: All subjects received hearing aids, some selected by audiologist, some selected by consumer, and some programmed as placebo devices.
Measure Participants	53	51	50
Mean (Standard Deviation) [Proportion of time had difficulties]	0.17 (0.12)	0.12 (0.12)	0.04 (0.10)

2. Secondary Outcome

Title	Connected Speech Test (CST) Benefit
Description	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.
Time Frame	two times: at hearing-aid fit and at 6-weeks post-fit

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Audiologist-Based	Consumer Decides	Placebo
Arm/Group Description	Audiologist selects hearing aid for patient hearing aid: All subjects received hearing aids, some selected by audiologist, some selected by consumer, and some programmed as placebo devices.	Consumer selects hearing aid hearing aid: All subjects received hearing aids, some selected by audiologist, some selected by consumer, and some programmed as placebo devices.	Patient fitted with hearing aid that is acoustically transparent. hearing aid: All subjects received hearing aids, some selected by audiologist, some selected by consumer, and some programmed as placebo devices.
Measure Participants	53	51	50
Mean (Standard Deviation) [Percentage of keywords correct]	21.3 (19.4)	26.6 (16.1)	8.7 (21.2)

Adverse Events

Time Frame	46 months
Arm/Group Title	Audiologist-Based		Consumer Decides		Placebo
Arm/Group Description	Audiologist selects hearing aid for patient hearing aid: All subjects received hearing aids, some selected by audiologist, some selected by consumer, and some programmed as placebo devices.		Consumer selects hearing aid hearing aid: All subjects received hearing aids, some selected by audiologist, some selected by consumer, and some programmed as placebo devices.		Patient fitted with hearing aid that is acoustically transparent. hearing aid: All subjects received hearing aids, some selected by audiologist, some selected by consumer, and some programmed as placebo devices.
All Cause Mortality
	Audiologist-Based		Consumer Decides		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/53 (0%)		0/51 (0%)		0/50 (0%)
Serious Adverse Events
	Audiologist-Based		Consumer Decides		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/53 (0%)		0/51 (0%)		0/50 (0%)
Other (Not Including Serious) Adverse Events
	Audiologist-Based		Consumer Decides		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/53 (0%)		0/51 (0%)		0/50 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.