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Device
Focused Multipolar Stimulation for Hearing Loss (SASC Trial)
N/A
Recruiting
Research Sponsored by Cochlear
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
18 years of age or older
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 weeks
Awards & highlights
SASC Trial Summary
This trial will explore ways to improve hearing performance for cochlear implant recipients. It will review and adjust device parameters to maximize hearing benefits.
Who is the study for?
This trial is for adults over 18 with bilateral sensorineural hearing loss who are candidates for unilateral cochlear implantation, fluent in the speech testing language, and willing to follow study requirements. Excluded are those with acoustic nerve lesions, additional handicaps affecting evaluations, unrealistic expectations about the procedure's outcomes, or current participation in other interventional trials.Check my eligibility
What is being tested?
The study tests a new Focused Multipolar Stimulation (FMS) strategy against the standard Monopolar stimulation in cochlear implants. It aims to improve hearing by adjusting device parameters and fitting based on ongoing reviews within technical limits.See study design
What are the potential side effects?
As this is an early feasibility study focusing on device parameter adjustments rather than drugs or invasive procedures, specific side effects are not detailed but may include typical risks associated with cochlear implant surgery and device use.
SASC Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
SASC Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mean difference across Spectral resolution (QSMD)
Mean difference across maximum map stimulation (C) levels
Mean difference across phoneme discrimination (LIT- Language independent test)
SASC Trial Design
1Treatment groups
Experimental Treatment
Group I: Adult Cochlear implantExperimental Treatment1 Intervention
Adult cochlear implant recipients receiving different combinations of alternative modes and, sound coding parameters
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Who is running the clinical trial?
CochlearLead Sponsor
89 Previous Clinical Trials
6,011 Total Patients Enrolled
80 Trials studying Hearing Loss
5,742 Patients Enrolled for Hearing Loss
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a cochlear implant now or had one in the past.I have been diagnosed with auditory neuropathy.I am 18 years old or older.Employees of Cochlear or companies hired by Cochlear for this study are not eligible.I am a candidate for a cochlear implant due to hearing loss in both ears and have decided to proceed.I am deaf because of issues with my hearing nerve or brain pathways.Other disabilities that would make it hard for you to take part in the hearing tests.I experienced severe hearing loss in one ear before I turned five.I have had severe to profound hearing loss for over 20 years in one ear.My inner ear has a condition that could interfere with a hearing device's surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Adult Cochlear implant
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is participation in this trial still available to potential subjects?
"Contrary to expectation, clinicaltrials.gov does not list this trial as actively recruiting patients at present. It was originally posted on January 31st 2023 and has since been updated November 29th 2022; however, 168 other trials are currently seeking participants."
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