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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

No Placebo-Only Group

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 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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-implantation, 12 months post-activation for reporting.

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.