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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorAdventHealth

About this trial

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.

Eligibility criteria

Qualifiers

Cochlear implant candidates >18 years of age

LFPTA (125Hz, 250Hz, 500Hz) <80dB

Disqualifiers

Pediatric patients (below the age of 18)

LFPTA (125Hz, 250Hz, 500Hz) >80dB

Revision cases

Severe comorbidities that contraindicate surgery.

Trial design

Treatments tested in this trial

  • IotaSoft Robotic Insertion System
  • Manual Cochlear Implant Insertion

Treatment groups

32 Participants
are divided into 2 treatment groups

Sponsors and collaborators