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Search / Trial NCT07081542

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

Launched by ADVENTHEALTH · Jul 15, 2025

Trial Information

Current as of July 26, 2025

Not yet recruiting

Keywords

Cochlear Implant Robotic Cochlear Implant Insertion Hearing Performance Speech Perception Electrocochleography Hearing Rehabilitation Postoperative Hearing Outcomes Minimally Invasive Ent Surgery

ClinConnect Summary

This study is looking at two ways of putting in cochlear implants, which are devices that help people with severe hearing loss hear better. One method uses a robot to assist the surgeon, while the other is done entirely by hand. The goal is to see which method leads to better hearing one year after surgery. The researchers will also check things like how long the surgery takes, the health of the inner ear, and how well the hearing nerve works after the implant. Everyone in the study will get the same type of cochlear implant and follow-up care.

Adults over 18 who are candidates for cochlear implants and have a certain level of hearing loss may be eligible to join. People with very severe hearing loss, previous cochlear implant surgeries, serious health problems, or certain ear conditions won’t be able to participate. Also, participants need to speak English or Spanish. If you take part, you’ll be randomly assigned to either the robotic or manual surgery group, and your hearing will be checked over the following year. This research could help improve how cochlear implants are placed in the future, potentially leading to better hearing results for patients.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Cochlear implant candidates \>18 years of age
  • LFPTA (125Hz, 250Hz, 500Hz) \<80dB
  • Exclusion Criteria:
  • Pediatric patients (below the age of 18)
  • LFPTA (125Hz, 250Hz, 500Hz) \>80dB
  • Revision cases
  • Severe comorbidities that contraindicate surgery.
  • Preexisting cochlear anomalies.
  • Do not speak English or Spanish

About Adventhealth

AdventHealth is a comprehensive, faith-based healthcare organization dedicated to providing holistic care and advancing medical research through innovative clinical trials. With a commitment to improving patient outcomes and enhancing the quality of life, AdventHealth integrates cutting-edge technology and compassionate care across its extensive network of hospitals and outpatient facilities. The organization emphasizes a patient-centered approach, fostering collaboration among multidisciplinary teams to explore new treatment options and therapies. By participating in clinical research, AdventHealth aims to contribute to the advancement of medical knowledge and deliver transformative healthcare solutions to communities it serves.

Locations

Kissimmee, Florida, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported