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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months, 6 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
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.

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

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

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
2,358 Previous Clinical Trials
3,419,719 Total Patients Enrolled
8 Trials studying Hearing Loss
53,237 Patients Enrolled for Hearing Loss
Patient-Centered Outcomes Research InstituteOTHER
549 Previous Clinical Trials
29,996,426 Total Patients Enrolled
5 Trials studying Hearing Loss
30,528 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research study still have room for participants?

"Affirmative. Online records from clinicaltrials.gov verify that this study, which was initially advertised on April 26th 2021, is still searching for candidates to participate in the experiment. 350 recruits are needed at two different sites."

Answered by AI

What is the current enrollment figure for this research project?

"Affirmative. According to the clinicaltrials.gov website, this experimental trial has been open since April 26th 2021 and is actively recruiting participants. Specifically, 350 subjects are expected from two sites of enrolment."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
South Carolina
How old are they?
18 - 65
What site did they apply to?
Duke University Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Hearing loss is a real challenge, like to find things that help.
PatientReceived 2+ prior treatments

How responsive is this trial?

Average response time
  • < 2 Days
Most responsive sites:
  1. Duke University Medical Center: < 48 hours
Typically responds via
Phone Call
Recent research and studies
clinicaltrials.govStudy
Evaluation of Unilateral vs Bilateral Hearing Aids for the Treatment of Age-related Hearing Loss
2021. "Evaluation of Unilateral vs Bilateral Hearing Aids for the Treatment of Age-related Hearing Loss". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04739436.
All > Hearing Loss > Aids
~18 spots leftby Jul 2024
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