MedTrace Logo

Safety and Effectiveness of Cochlear Implantation in an Expanded Adult Population

NCT06293482 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-04-13

No results posted yet for this study

Summary

This study aims to evaluate the safety and efficacy of cochlear implantation for adults with bilateral sensorineural hearing loss who currently do not meet the FDA-approved indications for cochlear implantation. Following cochlear implantation, participants will complete speech perception assessments and questionnaires over the course of seven visits.

Conditions

  • Hearing Loss, Sensorineural
  • Hearing Loss, Bilateral

Interventions

DEVICE

Cochlear™ Nucleus® System

The Cochlear™ Nucleus ® System is a commercially available system intended for restoration of hearing sensation through electrical stimulation of the auditory nerve in adult patients with bilateral symmetrical sensorineural hearing loss.

Sponsors & Collaborators

  • Cochlear

    lead INDUSTRY

  • NAMSA

    collaborator OTHER

  • LWB Consulting

    collaborator UNKNOWN

  • Althea Anagnostopoulos Harrington

    collaborator UNKNOWN

  • MV Clinical Research, LLC

    collaborator UNKNOWN

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-17
Primary Completion
2026-04-30
Completion
2028-10-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT06293482 on ClinicalTrials.gov