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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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 36 months post-activation

Awards & highlights

PAS-SSD Trial 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.Check my eligibility

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.See study design

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.

PAS-SSD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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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.

PAS-SSD Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 36 months post-activation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~36 months post-activation

This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months post-activation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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.

Number of procedure and device related adverse events classified by type, frequency and severity.

Secondary outcome measures

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.

PAS-SSD Trial Design

1Treatment groups

Experimental Treatment

Group I: Children and adults with unilateral hearing loss/single-sided deafnessExperimental Treatment1 Intervention

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

CochlearLead Sponsor

89 Previous Clinical Trials

5,971 Total Patients Enrolled

NAMSAOTHER

45 Previous Clinical Trials

16,863 Total Patients Enrolled

Jillian CrossonStudy DirectorCochlear

Media Library

The Cochlear™ Nucleus® Cochlear Implant (CI) System (Cochlear Implant) Clinical Trial Eligibility Overview. Trial Name: NCT05318417 — N/A

Unilateral Hearing Loss Research Study Groups: Children and adults with unilateral hearing loss/single-sided deafness

Unilateral Hearing Loss Clinical Trial 2023: The Cochlear™ Nucleus® Cochlear Implant (CI) System Highlights & Side Effects. Trial Name: NCT05318417 — N/A

The Cochlear™ Nucleus® Cochlear Implant (CI) System (Cochlear Implant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05318417 — N/A

Frequently Asked Questions

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

Is there a present opportunity for individuals to enroll in the experiment?

"Clinicaltrials.gov lists this study as currently recruiting for participants, which began on the 19th of August 2022 and was recently updated October 6th that same year."

Answered by AI

Is there a widespread implementation of this clinical trial in Canada?

"Eight healthcare institutions have begun the recruitment process for this medical trial, including University of Texas Southwestern Medical Center- Department of Otolaryngology Head and Neck Surgery in Dallas, University of Iowa in Iowa City, Stanford University in Palo Alto as well as other facilities."

Answered by AI

How many participants are involved in this clinical investigation?

"This trial necessitates 60 qualified participants and can be accessed at two centres: University of Texas Southwestern Medical Center- Department of Otolaryngology Head and Neck Surgery in Dallas, Texas, or the University of Iowa in Iowa City."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Investigation to Evaluate the Safety and Effectiveness of Cochlear Implantation in Children and Adults With Unilateral Hearing Loss/Single-sided Deafness

2022. "Investigation to Evaluate the Safety and Effectiveness of Cochlear Implantation in Children and Adults With Unilateral Hearing Loss/Single-sided Deafness". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05318417.

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