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

NCT05318417 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-09-02

No results posted yet for this study

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

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®.

Sponsors & Collaborators

  • NAMSA

    collaborator OTHER

  • Cochlear

    lead INDUSTRY

Principal Investigators

  • Jillian Crosson · Cochlear

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-19
Primary Completion
2027-05-31
Completion
2027-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05318417 on ClinicalTrials.gov