Trials / Active Not Recruiting
Active Not RecruitingNCT06293482
Safety and Effectiveness of Cochlear Implantation in an Expanded Adult Population
A Pivotal, Prospective, Open-label, Multi-center Study of Safety and Effectiveness of Cochlear Implantation in an Expanded Population of Adults With Bilateral Sensorineural Hearing Loss
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- Sponsor
- Cochlear · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2024-09-17
- Primary completion
- 2026-04-01
- Completion
- 2028-10-01
- First posted
- 2024-03-05
- Last updated
- 2026-04-13
Locations
9 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06293482. Inclusion in this directory is not an endorsement.