Trial Outcomes & Findings for Longitudinal Outcomes of Hearing Aids (NCT NCT04030299)

Last Updated: 2024-08-13

Results Overview

The Glasgow Hearing Aid Benefit Profile (GHABP) is a questionnaire that measures hearing aid users' listening experience in four situations (TV listening, small conversation in quiet, conversation in noise, and group conversation). The score ranges from 0 (no benefit) to 5 (lots of benefit). The score at 1-week, 6-week and 12-week post intervention is the primary outcome.

Recruitment status

COMPLETED

Study phase

Target enrollment

34 participants

Primary outcome timeframe

1-week, 6-week, and 12-week post-intervention

Results posted on

2024-08-13

Participant Flow

Participants were recruited between September 2019 and September 2022. Participants were recruited from the an established participant registry and through mass emails to the University of Iowa community.

Participant milestones

Participant milestones
Measure	OTC Group In this group, the over-the-counter fitting will be used to provide hearing aids. Over-the-counter fitting: In this group, pre-configured hearing aids, which simulate over-the-counter hearing aids, will be provided to subjects. Subjects will take the full initiative and responsibility for learning and using hearing aids.
Overall Study STARTED	34
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Reasons for withdrawal
Measure	OTC Group In this group, the over-the-counter fitting will be used to provide hearing aids. Over-the-counter fitting: In this group, pre-configured hearing aids, which simulate over-the-counter hearing aids, will be provided to subjects. Subjects will take the full initiative and responsibility for learning and using hearing aids.
Overall Study Coronavirus disease 2019 (COVID-19)	7
Overall Study Withdrawal by Subject	3

Baseline Characteristics

Longitudinal Outcomes of Hearing Aids

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	OTC Group n=24 Participants In this group, the over-the-counter fitting will be used to provide hearing aids. Over-the-counter fitting: In this group, pre-configured hearing aids, which simulate over-the-counter hearing aids, will be provided to subjects. Subjects will take the full initiative and responsibility for learning and using hearing aids.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants
Age, Categorical >=65 years	17 Participants n=5 Participants
Age, Continuous	70.29 Years STANDARD_DEVIATION 7.68103 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	24 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	24 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	24 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1-week, 6-week, and 12-week post-intervention

Outcome measures

Outcome measures
Measure	OTC Group n=24 Participants In this group, the over-the-counter fitting will be used to provide hearing aids. Over-the-counter fitting: In this group, pre-configured hearing aids, which simulate over-the-counter hearing aids, will be provided to subjects. Subjects will take the full initiative and responsibility for learning and using hearing aids.
Hearing Aid Benefit as Measured by the Glasgow Hearing Aid Benefit Profile (GHABP) 1-week post-intervention	3.68 score on a scale Standard Deviation 0.695
Hearing Aid Benefit as Measured by the Glasgow Hearing Aid Benefit Profile (GHABP) 6-week post intervention	3.55 score on a scale Standard Deviation 0.648
Hearing Aid Benefit as Measured by the Glasgow Hearing Aid Benefit Profile (GHABP) 12-week post-intervention	3.63 score on a scale Standard Deviation 0.715

SECONDARY outcome

Timeframe: 1-week, 6-week, and 12-week post-intervention

The PHAP is a questionnaire designed to measures the performance of hearing aids in speech communication. The score ranges from 1 (good performance) to 99 (poor performance).

Outcome measures

Outcome measures
Measure	OTC Group n=24 Participants In this group, the over-the-counter fitting will be used to provide hearing aids. Over-the-counter fitting: In this group, pre-configured hearing aids, which simulate over-the-counter hearing aids, will be provided to subjects. Subjects will take the full initiative and responsibility for learning and using hearing aids.
Hearing Aid Performance/Benefit as Measured Using the Profile of Hearing Aid Performance (PHAP) 1-week post intervention	30.5 score on a scale Standard Deviation 13.7
Hearing Aid Performance/Benefit as Measured Using the Profile of Hearing Aid Performance (PHAP) 6-week post intervention	30.4 score on a scale Standard Deviation 14.5
Hearing Aid Performance/Benefit as Measured Using the Profile of Hearing Aid Performance (PHAP) 12-week post intervention	29.5 score on a scale Standard Deviation 14.3

SECONDARY outcome

Timeframe: 1-week, 6-week, and 12-week post-intervention

The HHIE and HHIA are questionnaires designed to measure subject's perceived hearing handicap. For subjects order and younger 65 years old, the HHIE and HHIA will be used, respectively. The score ranges from 0 (no handicap) to 100 (more handicap).

Outcome measures

Outcome measures
Measure	OTC Group n=22 Participants In this group, the over-the-counter fitting will be used to provide hearing aids. Over-the-counter fitting: In this group, pre-configured hearing aids, which simulate over-the-counter hearing aids, will be provided to subjects. Subjects will take the full initiative and responsibility for learning and using hearing aids.
Hearing Handicap as Measured by Hearing Handicap Inventory for the Elderly (HHIE) or Hearing Handicap Inventory for Adults (HHIA) 1-week post intervention	20.2 score on a scale Standard Deviation 14.3
Hearing Handicap as Measured by Hearing Handicap Inventory for the Elderly (HHIE) or Hearing Handicap Inventory for Adults (HHIA) 6-week post intervention	13 score on a scale Standard Deviation 10.9
Hearing Handicap as Measured by Hearing Handicap Inventory for the Elderly (HHIE) or Hearing Handicap Inventory for Adults (HHIA) 12-week post intervention	17.7 score on a scale Standard Deviation 16.6

SECONDARY outcome

Timeframe: 1-week, 6-week, and 12-week post-intervention

The HASS is a questionnaire developed to measures subject's perceived hearing aid satisfaction. The score ranges from 0 (low satisfaction) to 10 (high satisfaction).

Outcome measures

Outcome measures
Measure	OTC Group n=20 Participants In this group, the over-the-counter fitting will be used to provide hearing aids. Over-the-counter fitting: In this group, pre-configured hearing aids, which simulate over-the-counter hearing aids, will be provided to subjects. Subjects will take the full initiative and responsibility for learning and using hearing aids.
Hearing Aid Satisfaction as Measured by the Hearing Aid Satisfaction Survey (HASS) 1-week post intervention	3.6 score on a scale Standard Deviation 0.66
Hearing Aid Satisfaction as Measured by the Hearing Aid Satisfaction Survey (HASS) 6-week post intervention	3.5 score on a scale Standard Deviation 0.63
Hearing Aid Satisfaction as Measured by the Hearing Aid Satisfaction Survey (HASS) 12-week post intervention	3.5 score on a scale Standard Deviation 0.73

SECONDARY outcome

Timeframe: 6-week and 12-week post intervention

Willingness-to-pay (WTP) estimates the extent to which (in dollars) a subjects, at a maximum, is willing to pay out-of pocket for the amplification devices and the associated services used in the study..

Outcome measures

Outcome measures
Measure	OTC Group n=21 Participants In this group, the over-the-counter fitting will be used to provide hearing aids. Over-the-counter fitting: In this group, pre-configured hearing aids, which simulate over-the-counter hearing aids, will be provided to subjects. Subjects will take the full initiative and responsibility for learning and using hearing aids.
Willingness-to-pay 6-week post intervention	967.7 dollars Standard Deviation 1040
Willingness-to-pay 12-week post intervention	1104.7 dollars Standard Deviation 1312

SECONDARY outcome

Timeframe: 1-week, 6-week, and 12-week post-intervention

The WHODAS is a questionnaire designed to measure quality of life. The summary score ranges from 0 (No disability) to 100 (Full disability).

Outcome measures

Outcome measures
Measure	OTC Group n=24 Participants In this group, the over-the-counter fitting will be used to provide hearing aids. Over-the-counter fitting: In this group, pre-configured hearing aids, which simulate over-the-counter hearing aids, will be provided to subjects. Subjects will take the full initiative and responsibility for learning and using hearing aids.
Quality of Life as Measured by the World Health Organization's Disability Assessment Schedule 2.0 (WHODAS 2.0) 1-week post-intervention	7.5 score on a scale Standard Deviation 7.1
Quality of Life as Measured by the World Health Organization's Disability Assessment Schedule 2.0 (WHODAS 2.0) 6-week post-intervention	6.7 score on a scale Standard Deviation 6.5
Quality of Life as Measured by the World Health Organization's Disability Assessment Schedule 2.0 (WHODAS 2.0) 12-week post-intervention	7.5 score on a scale Standard Deviation 7.0

SECONDARY outcome

Timeframe: 1-week, 6-week, and 12-week post-intervention

The SADL is a questionnaire designed to measures subject's perceived hearing aid satisfaction. The score ranges from 1 (low satisfaction) to 7 (high satisfaction).

Outcome measures

Outcome measures
Measure	OTC Group n=20 Participants In this group, the over-the-counter fitting will be used to provide hearing aids. Over-the-counter fitting: In this group, pre-configured hearing aids, which simulate over-the-counter hearing aids, will be provided to subjects. Subjects will take the full initiative and responsibility for learning and using hearing aids.
Hearing Aid Satisfaction as Measured by the Satisfaction With Amplification in Daily Life (SADL) 1-week post intervention	4.6 score on a scale Standard Deviation 1.3
Hearing Aid Satisfaction as Measured by the Satisfaction With Amplification in Daily Life (SADL) 6-week post intervention	4.4 score on a scale Standard Deviation 1.2
Hearing Aid Satisfaction as Measured by the Satisfaction With Amplification in Daily Life (SADL) 12-week post intervention	4.6 score on a scale Standard Deviation 1.4

SECONDARY outcome

Timeframe: 1-week, 6-week, and 12-week post-intervention

The CST is a speech recognition test designed to simulate daily speech communication. The score ranges from 0 (understand no speech) to 100 (understand all speech).

Outcome measures

Outcome measures
Measure	OTC Group n=22 Participants In this group, the over-the-counter fitting will be used to provide hearing aids. Over-the-counter fitting: In this group, pre-configured hearing aids, which simulate over-the-counter hearing aids, will be provided to subjects. Subjects will take the full initiative and responsibility for learning and using hearing aids.
Speech Recognition Performance as Measured by the Connected Speech Test (CST) 1-week post intervention	64.9 score on a scale Standard Deviation 27.8
Speech Recognition Performance as Measured by the Connected Speech Test (CST) 6-week post intervention	79.6 score on a scale Standard Deviation 13.5
Speech Recognition Performance as Measured by the Connected Speech Test (CST) 12-week post intervention	76.8 score on a scale Standard Deviation 17.1

Adverse Events

OTC Group

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

Dr. Yu-Hsaing Wu

The University of Iowa

Phone: (319) 335-9758

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place