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

Part of paid clinical trials in Kissimmee, Florida.

Sponsor
AdventHealth
Study ID
NCT07081542
Status
Not Yet Recruiting

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Conditions

  • Bilateral Hearing Loss
  • Cochlear Implantation
  • Hearing Disorders
  • Hearing Disorders and Deafness
  • Hearing Impairment
  • Inner Ear Disorders
  • Sensorineural Hearing Loss

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • IotaSoft Robotic Insertion System — DEVICE
    The IotaSoft robotic insertion device is an FDA-approved tool designed to provide precise and controlled insertion of the cochlear implant electrode array to minimize trauma during implantation.
  • Manual Cochlear Implant Insertion — PROCEDURE
    Standard surgical technique for manually inserting the cochlear implant electrode array. This method reflects the current standard of care without the assistance of robotic tools.

Study Details

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.

Key Dates

Start date
Jan 1, 2026
Status verified
May 2025
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
32 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Robotic-Assisted Cochlear Implant Insertion
    Surgical technique using robotic assistance (IotaSoft system) to perform the cochlear implant electrode array insertion into the cochlea.
  • Active Comparator: Manual Cochlear Implant Insertion
    Standard surgical technique for inserting the cochlear implant electrode array without robotic assistance. This represents the standard of care method.

Primary Outcome Measure

Change in Low-Frequency Pure Tone Average (LFPTA) [ Time Frame: Baseline (pre-op) to 12 months post-activation ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
AdventHealth CelebrationKissimmeeFlorida34747
Petronio Martins, MHA
[email protected]
407-303-5503
Bridget Miller, MS, MPH
[email protected]
407-303-5503
Michael Seidman, MD, FACS (PRINCIPAL_INVESTIGATOR)

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