NCT05318417

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Cochlear · Industry
• Sex: All
• Age: 5 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hearing Loss, Unilateral
• Deafness, Unilateral

Interventions

Type	Name	Description
DEVICE	The 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®.

Timeline

• Start date: 2022-08-19
• Primary completion: 2027-05-01
• Completion: 2027-06-01
• First posted: 2022-04-08
• Last updated: 2025-09-02

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated device study