Unilateral hearing aid fitting group for Hearing Loss

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Hearing LossHearing amplification - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will compare the benefits of using two hearing aids to using just one.

Eligible Conditions
  • Hearing Loss

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

0 Primary · 14 Secondary · Reporting Duration: 3 months, 6 months

3 months
Experience with hearing aid assignment
Hours of Hearing Aid Use
Number of participants in each arm that chose 0 hearing aids as measured by patient preference
Number of participants in each arm that chose 1 hearing aid as measured by patient preference
Number of participants in each arm that chose 2 hearing aids as measured by patient preference
Preference with hearing aid assignment
Month 6
Change in Hearing Aid Satisfaction
3 months, 6 months
Change in Hearing Aid Benefit
Change in global hearing aid outcomes
Baseline
Hearing aid expectations
Baseline, 3 months
Hearing
Change in Hearing Aid Benefit as measured by speech in noise performance
Month 6
Change in Hearing Related Quality Life
Change in complex ecological listening

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Unilateral hearing aid fitting group
1 of 1

Active Control

350 Total Participants · 1 Treatment Group

Primary Treatment: Unilateral hearing aid fitting group · No Placebo Group · N/A

Unilateral hearing aid fitting group
Device
ActiveComparator Group · 1 Intervention: Hearing amplification · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 3 months, 6 months

Who is running the clinical trial?

Patient-Centered Outcomes Research InstituteOTHER
493 Previous Clinical Trials
29,829,859 Total Patients Enrolled
4 Trials studying Hearing Loss
2,366 Patients Enrolled for Hearing Loss
Duke UniversityLead Sponsor
2,178 Previous Clinical Trials
3,200,344 Total Patients Enrolled
7 Trials studying Hearing Loss
23,237 Patients Enrolled for Hearing Loss
Sherri Smith, AuD,PhDPrincipal InvestigatorDuke Health

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a 50+ years of age or older.
You have a hearing loss of at least 20 dB in one or both ears.
You are willing to purchase study-specific hearing aids.

Who else is applying?

What state do they live in?
South Carolina100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Duke University Medical Center100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%

How responsive is this trial?

Average response time
  • < 2 Days
Typically responds via
Phone Call100.0%
Most responsive sites:
  1. Duke University Medical Center: < 48 hours