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Hearing Amplification

Unilateral vs Bilateral Hearing Aids for Age-Related Hearing Loss

N/A
Waitlist Available
Led By Sherri Smith, AuD,PhD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Mild to moderate sensorineural hearing loss (defined by a pure-tone average at 500, 1000, and 2000 Hz of <55 dB HL in each ear, and the 3000 Hz and 4000 Hz threshold <80 in each ear, based on a hearing test obtained within the last 6 months by a licensed audiologist)
Willing to purchase study-specific hearing aid(s)
Must not have
Co-morbid condition that would interfere with study (e.g., dementia, blindness, neurologic pathology)
Severe tinnitus as the reason for seeking amplification
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months, 6 months
Awards & highlights
No Placebo-Only Group

Summary

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

Who is the study for?
This trial is for people over 50 with mild to moderate hearing loss in both ears, who can read English and are considering buying hearing aids. They must have symmetrical hearing loss, no middle ear issues or severe tinnitus, and not used hearing aids for more than 3 months.
What is being tested?
The study compares the effectiveness of using one versus two hearing aids in individuals with age-related hearing loss. Participants will be randomly assigned to either get a single (unilateral) or a pair (bilateral) of commercially available hearing aids.
What are the potential side effects?
While not explicitly stated, typical side effects from using hearing aids may include discomfort, feedback noises, difficulty adjusting to amplified sounds, and potential worsening of tinnitus.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have mild to moderate hearing loss, confirmed by a recent test.
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I am willing to buy the hearing aids required for the study.
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I am 50 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any health conditions like dementia or blindness that would prevent me from participating in the study.
Select...
I am seeking a hearing aid because I have severe ringing in my ears.
Select...
I have hearing issues possibly due to middle ear problems.
Select...
My hearing loss comes and goes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months, 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months, 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Change in Hearing Aid Benefit
Hearing
Change in Hearing Aid Benefit as measured by speech in noise performance
+11 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Bilateral hearing aid fitting groupExperimental Treatment1 Intervention
Group II: Unilateral hearing aid fitting groupActive Control1 Intervention

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,451 Previous Clinical Trials
3,066,720 Total Patients Enrolled
8 Trials studying Hearing Loss
53,234 Patients Enrolled for Hearing Loss
Patient-Centered Outcomes Research InstituteOTHER
573 Previous Clinical Trials
27,077,952 Total Patients Enrolled
5 Trials studying Hearing Loss
30,529 Patients Enrolled for Hearing Loss
Sherri Smith, AuD,PhDPrincipal InvestigatorDuke Health

Media Library

Hearing Aid (Hearing Amplification) Clinical Trial Eligibility Overview. Trial Name: NCT04739436 — N/A
Hearing Loss Research Study Groups: Bilateral hearing aid fitting group, Unilateral hearing aid fitting group
Hearing Loss Clinical Trial 2023: Hearing Aid Highlights & Side Effects. Trial Name: NCT04739436 — N/A
Hearing Aid (Hearing Amplification) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04739436 — N/A
Hearing Loss Patient Testimony for trial: Trial Name: NCT04739436 — N/A
~78 spots leftby Nov 2025
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