Trials / Active Not Recruiting
Active Not RecruitingNCT06699797
Pivotal Clinical Trial Evaluating the Safety and Efficacy of the Fully Implanted Acclaim Cochlear Implant
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 56 (estimated)
- Sponsor
- Envoy Medical Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The goal of this clinical trial is to learn if the Acclaim CI works to treat severe to profound sensorineural hearing loss in adults. It was also learn about the safety of the Acclaim CI implant. The main questions it aims to answer are: * Does the Acclaim CI device help participants hear words better compared to before the implants? * What medical problems do participants have after the Acclaim CI device was implanted? Participants will: * Have the Acclaim CI implanted; and * Visit the clinical site for checkups and tests at 1-Month, 3-Months, 6-Months, and at 1-year and 2-years after the device has been turned on.
Conditions
- Sensori-Neural Deafness
- Sensorineural Hearing Loss
- Sensorineural Hearing Loss (Disorder)
- Sensorineural Hearing Loss, Bilateral
- Sensorineural Hearing Loss, Profound
- Sensorineural Hearing Loss, Severe
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Acclaim Cochlear Implant | Participants with the Acclaim CI device will be tested during follow-up with their hearing results compared to baseline (before the device implant procedure). |
Timeline
- Start date
- 2025-02-06
- Primary completion
- 2027-04-01
- Completion
- 2028-04-01
- First posted
- 2024-11-21
- Last updated
- 2026-03-16
Locations
7 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06699797. Inclusion in this directory is not an endorsement.