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NCT06699797 · ClinicalTrials.gov registry record · NA
Pivotal Clinical Trial Evaluating the Safety and Efficacy of the Fully Implanted Acclaim Cochlear Implant
A NA study of Sensorineural Hearing Loss and Sensorineural Hearing Loss, Bilateral, sponsored by Envoy Medical Corporation.
- Active
- Registry status
- NA
- Development phase
- 56
- Enrollment target
- 7
- Study locations
NCT06699797 is a NA study of Sensorineural Hearing Loss and Sensorineural Hearing Loss, Bilateral that is active but no longer recruiting, run by Envoy Medical Corporation. The registered enrollment target is 56 participants, below the 127-participant average among 13 other Sensorineural Hearing Loss trials with a reported enrollment target (56% lower). The trial reports 7 study locations across 7 states.
The verdict
NCT06699797, a NA study of Sensorineural Hearing Loss and Sensorineural Hearing Loss, Bilateral, is active but no longer recruiting, sponsored by Envoy Medical Corporation.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 56 participants
- Enrollment target
- 7
- Study locations
Study 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 Studied
Interventions
- DEVICE Acclaim Cochlear Implant
Study Locations (7)
Arizona
- Center for Neurosciences Ear and Hearing Center - Tucson
California
- Shohet Ear Associates - Seal Beach
Florida
- University of Florida Health - Gainesville
Minnesota
- Mayo Clinic - Rochester
Ohio
- Cleveland Clinic - Cleveland
Oklahoma
- Hearts for Hearing - Oklahoma City
South Carolina
- MUSC Health - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2025-02-06 |
| Est. Completion | 2028-04 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06699797
The ClinicalTrials.gov registry entry for NCT06699797 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 56 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 127-participant average among 13 other Sensorineural Hearing Loss trials with a reported enrollment target (56% lower). The listed sponsor is Envoy Medical Corporation, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 6 conditions, with Sensorineural Hearing Loss appearing as the primary indexed condition, and to 1 intervention - of which Acclaim Cochlear Implant is the first listed.
NCT06699797 reports 7 study locations spanning 7 distinct geographic areas - top geographies include Arizona, California, Florida.
Frequently Asked Questions
What is clinical trial NCT06699797 about?
NCT06699797 is a clinical study titled "Pivotal Clinical Trial Evaluating the Safety and Efficacy of the Fully Implanted Acclaim Cochlear Implant". 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 bet...
What is the current status of trial NCT06699797?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 56 participants. The study started on 2025-02-06. Estimated completion is 2028-04.
What conditions does trial NCT06699797 study?
This clinical trial studies the following conditions: Sensorineural Hearing Loss, Sensorineural Hearing Loss, Bilateral, Sensori-Neural Deafness, Sensorineural Hearing Loss (Disorder), Sensorineural Hearing Loss, Profound.
What interventions are being tested in trial NCT06699797?
The interventions under investigation include: Acclaim Cochlear Implant (DEVICE).
Who is sponsoring clinical trial NCT06699797?
This trial is sponsored by Envoy Medical Corporation, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06699797 being conducted?
This trial has 7 study locations across Arizona, California, Florida, Minnesota, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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