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Cochlear Implant
Cochlear Implant for Single-Sided Deafness (PAS-SSD 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
Individuals 18 years or older (Group A)
Children 5 years to 17 years, 11 months (Group B)
Must not have
Ossification, abnormal cochlear nerve or any other cochlear anomaly that might prevent complete insertion of the electrode array
Hearing loss of neural or central origin, including auditory neuropathy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-implantation, 12 months post-activation
Awards & highlights
Summary
This trial is testing whether a cochlear implant (a device that helps people with hearing loss hear) is safe and effective for people with unilateral hearing loss or single-sided deafness who are 5 years or older.
Who is the study for?
This trial is for children (5-17 years) and adults (18+ years) with severe unilateral hearing loss or single-sided deafness. Participants must have tried conventional treatments like hearing aids, bone-conduction devices, or CROS technology for at least two weeks. They should not have cochlear anomalies that prevent electrode insertion, previous cochlear implants, neural origin hearing loss, long-term (>10 years) profound sensorineural HL, middle-ear infections or be pregnant/breastfeeding.
What is being tested?
The study evaluates the Cochlear™ Nucleus® Cochlear Implant System's safety and effectiveness in individuals aged 5 and above with Unilateral Hearing Loss/Single-Sided Deafness. It aims to support a change indication for use of this system by assessing its continued efficacy.
What are the potential side effects?
Potential side effects may include risks associated with surgery such as infection or inflammation at the implant site, issues related to device performance like malfunctioning hardware, changes in hearing levels on either ear post-surgery and general discomfort from wearing an external device.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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My child is between 5 years and 17 years, 11 months old.
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I am 18 years old or older.
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I am between 5 and 17 years old.
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I have severe hearing loss with very low speech understanding.
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I have severe hearing loss, with very low scores on hearing tests.
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My hearing is normal or almost normal.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have no inner ear conditions that would interfere with an electrode implant.
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I have hearing loss that is not caused by ear damage.
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I have had severe hearing loss for more than 10 years.
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I have a long-term ear infection or hearing loss due to issues in the ear's structure.
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I have no health or mental conditions that prevent me from having surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pre-implantation, 12 months post-activation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-implantation, 12 months post-activation
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in sentence in noise scores at 12 months post-activation in the binaural (CI and normal hearing (NH)) listening condition compared to preoperatively in the best listening (NH alone or NH and hearing aid) condition in 3 speaker configurations.
Secondary study objectives
Change in participant reported spatial hearing at 12 months post-activation compared to pre-operative ratings.
Change in word recognition at 12 months post-activation in the CI alone condition compared to preoperative aided condition in the poorer hearing ear alone.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Children and adults with unilateral hearing loss/single-sided deafnessExperimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
CochlearLead Sponsor
90 Previous Clinical Trials
6,020 Total Patients Enrolled
NAMSAOTHER
49 Previous Clinical Trials
19,650 Total Patients Enrolled
Jillian CrossonStudy DirectorCochlear
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have tried or am willing to try hearing aids or devices for single-sided deafness for at least two weeks.I am 18 years old or older.My child is between 5 years and 17 years, 11 months old.I am 18 years old or older.I am between 5 and 17 years old.I have severe hearing loss with very low speech understanding.I have no inner ear conditions that would interfere with an electrode implant.I have hearing loss that is not caused by ear damage.You have had a cochlear implant before.I have severe hearing loss, with very low scores on hearing tests.I have had severe hearing loss for more than 10 years.I have a long-term ear infection or hearing loss due to issues in the ear's structure.I understand the realistic outcomes, risks, and limits of the trial as explained.I have no health or mental conditions that prevent me from having surgery.You have signs of thinking or learning problems.My hearing is normal or almost normal.
Research Study Groups:
This trial has the following groups:- Group 1: Children and adults with unilateral hearing loss/single-sided deafness
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.
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