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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adults age 18 or older with bilateral mild to moderate hearing loss
Experienced users must have at least 6 months Hearing Aid experience
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 of 1 day study
Awards & highlights
Study Summary
New and experienced hearing aid users will be fit with two hearing devices. One will be labeled as an OTC (Over-The-Counter) device, the other will be labeled as a Prescriptive (i.e. professionally fit) device. Both devices will be generically programmed for a mild to moderate hearing loss. An objective speech in noise test will be completed with both devices.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 of 1 day study
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 of 1 day study
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Quick Speech in Noise Test (QuickSIN)
Secondary outcome measures
Big Five Personality Inventory
Expected Consequences of Hearing Aid Ownership (ECHO)
Satisfaction of Amplification in Daily Life (SADL)
Trial Design
2Treatment groups
Experimental Treatment
Group I: Naive listenersExperimental Treatment2 Interventions
Participants who have never worn a hearing aid before. This group will be tested with both sets of devices, those labeled as "OTC" and those labeled as "Prescriptive"
Group II: Experienced usersExperimental Treatment2 Interventions
Participants who have at least six months experience wearing hearing aids. This group will be tested with both sets of devices, those labeled as "OTC", and those labeled as "Prescriptive"
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Audeo P hearing aid labeled as "Prescriptive"
2022
N/A
~20
Audeo P hearing aid labeled as "OTC"
2022
N/A
~20
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Who is running the clinical trial?
Sonova AGLead Sponsor
78 Previous Clinical Trials
1,847 Total Patients Enrolled
70 Trials studying Hearing Loss
1,653 Patients Enrolled for Hearing Loss
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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