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Comparative Analysis of Hearing Outcomes: Robotic vs. Manual Insertion of Cochlear Implants

StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Start date: Jul 30, 2025 to Jan 1, 2026v2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
31 trials monitored
See 2 trials at risk
This research study is evaluating two different methods of cochlear implant (CI) insertion - robotic-assisted insertion and manual insertion - to better understand how they affect hearing outcomes. Participants in this study will be randomly assigned to receive their cochlear implant using one of these two techniques. Both methods are performed in a standard operating room by qualified surgeons, and both are considered safe and approved for use. The main goal is to compare how well participants hear one year after surgery based on the insertion method used. The study will also look at things like surgical time, inner ear health, and how the hearing nerve responds. All participants will receive the same type of cochlear implant device and follow-up care. This study may help guide future surgical techniques and improve outcomes for individuals receiving cochlear implants.
Trial Details
NCT Number NCT07081542
Lead Sponsor AdventHealth
Conditions
(from sponsor)
Sensorineural Hearing Loss, Bilateral Hearing Loss, Cochlear Implantation, Hearing Disorders, Hearing Disorders and Deafness, Inner Ear Disorders, Hearing Impairment
Related terms Deafness, Hearing Disorders, Hearing Loss, Hearing Loss, Bilateral, Hearing Loss, Sensorineural, Vestibular Diseases
Enrollment 32 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov