RecruitingNot ApplicableNCT05318417

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

A Post-approval, Prospective, Nonrandomized, Single-arm Multicenter Investigation to Evaluate the Safety and Effectiveness of Cochlear Implantation in Children and Adults With Unilateral Hearing Loss/Single-sided Deafness

Sponsor

Cochlear

Enrollment

60 participants

Start Date

Aug 19, 2022

Study Type

INTERVENTIONAL

Conditions

Hearing Loss, Unilateral Deafness, Unilateral

Summary

The aim of the study is to assess the continued efficacy and safety of cochlear implantation in participants aged 5 years and above with Unilateral Hearing Loss (UHL)/Single Sided Deafness (SSD) supporting a change indication for use.

Eligibility

Min Age: 5 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called The Cochlear™ Nucleus® Cochlear Implant (CI) System for people with deafness, unilateral and hearing loss, unilateral. The study is currently recruiting participants at 8 locations. People eligible for this study include aged 5 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEThe Cochlear™ Nucleus® Cochlear Implant (CI) System

The Cochlear™ Nucleus® CI systems are designed to provide useful hearing. The system works by converting sound in the environment into electric pulses that stimulate the auditory nerve, allowing the brain to perceive sound. The Cochlear™ Nucleus® CI system has implanted and external components. Implanted component: The CI is surgically implanted under the skin behind the ear. It includes a receiver/stimulator to receive and decode the electrical signals from the sound processor and an electrode to deliver these signals to the cochlear. External components: The external components include a sound processor, and associated accessories and cables. The system is programmed by a Cochlear proprietary programming system, Custom Sound®.