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
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
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: DeviceTrial 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 Carolina | 100.0% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| Duke University Medical Center | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
How responsive is this trial?
Average response time
- < 2 Days
Typically responds via
| Phone Call | 100.0% |
Most responsive sites:
- Duke University Medical Center: < 48 hours
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Conditions
Cancer Related
Treatments