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SEDA for Hearing Loss
N/A
Recruiting
Led By David M. Landsberger
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
At least 12 years of age
Must not have
Anyone who is not a cochlear implant user or is aged under 12 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to year 2 (completion of experiment 1.2)
Awards & highlights
No Placebo-Only Group
Summary
This trial tests how well a noise reduction algorithm can help cochlear implant users ages 12+ understand speech better in different sound environments.
Who is the study for?
This trial is for cochlear implant users who are at least 12 years old and have been using their implant for over six months. Participants must be post-lingually deafened, meaning they lost hearing after acquiring language skills, and considered able to complete the study by the principal investigator.
What is being tested?
The trial is testing a new noise reduction algorithm called SEDA in various listening environments. The goal is to see if it helps people with cochlear implants understand speech better when there's background noise.
What are the potential side effects?
Since this trial involves a software algorithm rather than medication or invasive procedures, traditional side effects are not expected. However, participants may experience fatigue or frustration during testing.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 12 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not use a cochlear implant and am 12 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to year 2 (completion of experiment 1.2)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to year 2 (completion of experiment 1.2)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percent of Words Correctly Recognized in Noisy Conditions with Clinical NR
Percent of Words Correctly Recognized in Noisy Conditions with SEDA NR
Percent of Words Correctly Recognized in Noisy Conditions without NR
+8 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Cochlear Implant UsersExperimental Treatment1 Intervention
Participants will complete up to 4 experiments evaluating the use of the Speech Enhancement using Dynamic thresholding Approach (SEDA) algorithm. Each testing session will take between 4-6 hours to complete. Testing sessions will continue until the completion of the experiments.
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Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,415 Previous Clinical Trials
856,143 Total Patients Enrolled
16 Trials studying Hearing Loss
2,144 Patients Enrolled for Hearing Loss
National Institute on Deafness and Other Communication Disorders (NIDCD)NIH
361 Previous Clinical Trials
181,998 Total Patients Enrolled
61 Trials studying Hearing Loss
21,546 Patients Enrolled for Hearing Loss
David M. LandsbergerPrincipal InvestigatorNYU Langone Health
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not use a cochlear implant and am 12 years old or older.You have received a cochlear implant and have had at least 6 months of experience, no matter which company made the implant.The doctor thinks I can understand and do the study tasks.I am 12 years old or older.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Cochlear Implant Users
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.