Trial Outcomes & Findings for Evaluating Hearing Aid Service Delivery Models (NCT NCT01788423)

Last Updated: 2019-07-23

Results Overview

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).

Recruitment status

COMPLETED

Study phase

Target enrollment

323 participants

Primary outcome timeframe

two times: at hearing-aid fit and at 6-weeks post-fit

Results posted on

2019-07-23

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	Audiologist-Based 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 Decides 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.	Placebo 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.
Overall Study STARTED	53	55	55
Overall Study COMPLETED	53	51	50
Overall Study NOT COMPLETED	0	4	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Audiologist-Based 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 Decides 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.	Placebo 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.
Overall Study See Comments in Completed (above)	0	4	5

Baseline Characteristics

Evaluating Hearing Aid Service Delivery Models

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Audiologist-Based n=53 Participants 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 Decides n=51 Participants 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.	Placebo n=50 Participants 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 n=154 Participants Total of all reporting groups
Age, Continuous	69.9 years STANDARD_DEVIATION 5.6 • n=5 Participants	68.0 years STANDARD_DEVIATION 6.2 • n=7 Participants	69.5 years STANDARD_DEVIATION 6.7 • n=5 Participants	69.1 years STANDARD_DEVIATION 6.0 • n=4 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	26 Participants n=7 Participants	16 Participants n=5 Participants	67 Participants n=4 Participants
Sex: Female, Male Male	28 Participants n=5 Participants	25 Participants n=7 Participants	34 Participants n=5 Participants	87 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	52 Participants n=5 Participants	50 Participants n=7 Participants	50 Participants n=5 Participants	152 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	52 Participants n=5 Participants	50 Participants n=7 Participants	47 Participants n=5 Participants	149 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Region of Enrollment United States	53 Participants n=5 Participants	51 Participants n=7 Participants	50 Participants n=5 Participants	154 Participants n=4 Participants

PRIMARY outcome

Timeframe: two times: at hearing-aid fit and at 6-weeks post-fit

Outcome measures

Outcome measures
Measure	Audiologist-Based n=53 Participants 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 Decides n=51 Participants 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.	Placebo n=50 Participants 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.
Profile of Hearing Aid Performance Benefit (PHAB)	0.17 Proportion of time had difficulties Standard Deviation 0.12	0.12 Proportion of time had difficulties Standard Deviation 0.12	0.04 Proportion of time had difficulties Standard Deviation 0.10

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Audiologist-Based n=53 Participants 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 Decides n=51 Participants 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.	Placebo n=50 Participants 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.
Connected Speech Test (CST) Benefit	21.3 Percentage of keywords correct Standard Deviation 19.4	26.6 Percentage of keywords correct Standard Deviation 16.1	8.7 Percentage of keywords correct Standard Deviation 21.2

Adverse Events

Audiologist-Based

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Consumer Decides

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Larry E. Humes

Indiana University, Department of Speech and Hearing Sci

Phone: 812-855-3507

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place