Robotic versus manual cochlear implant electrode insertion to reduce inner-ear trauma.
Iowa Cochlear Implant Clinical Research Center Study on Robotic-Assisted Versus Manual Electrode Array Insertion
This test tries a robotic insertion tool versus the usual manual technique to see if it reduces inner-ear damage and preserves residual hearing in people getting cochlear implants.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Iowa Academic / other |
| Locations | 1 site (Iowa City, Iowa) |
| Trial ID | NCT06951594 on ClinicalTrials.gov |
What this trial studies
In this randomized interventional study adults receiving cochlear implants are assigned to electrode insertion either with the iotaSOFT™ robotic-assisted system or with conventional manual technique. The robotic system controls insertion speed (0.1–1.0 mm/sec) and can integrate intraoperative ECochG monitoring to permit micrometer-scale stopping when inner-ear responses change, aiming to reduce insertion force and pressure variability. Outcomes include postoperative CT measures of cochlear trauma, cochlear and auditory nerve function with ECochG and eCAP, and clinical outcomes such as residual acoustic hearing and speech perception scores. The trial is conducted at the University of Iowa and enrolls candidates with patent, normally formed cochleae who meet standard cochlear implant eligibility and have no cochlear ossification or other contraindications.
Who should consider this trial
Good fit: Adults eligible for cochlear implantation with normal cochlear anatomy, no ossification, and willingness to comply with study procedures are ideal candidates.
Not a fit: Patients with cochlear ossification, anatomical abnormalities that prevent full insertion, or medical/psychological contraindications are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, robotic-assisted insertion could lower intracochlear trauma, help preserve residual hearing, and improve speech outcomes after cochlear implantation.
How similar studies have performed: Cadaver and bench studies show the iotaSOFT™ system reduces insertion forces and intracochlear pressure compared with manual insertion, but clinical benefits in live patients remain unproven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Candidate for a cochlear implant according to CMS guidelines * Willingness to comply with all study requirements * Patent cochlea and normal cochlear anatomy, as confirmed by preoperative imaging * English speaking Exclusion Criteria: * Medical or psychological conditions that contraindicate undergoing surgery * Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array. * Unrealistic expectations on the part of the candidate and/or candidate's family, regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure(s) and prosthetic devices.
Where this trial is running
Iowa City, Iowa
- University of Iowa Healthcare — Iowa City, Iowa, United States (Recruiting)
Study contacts
- Principal investigator: Bruce Gantz, MD — University of Iowa
- Study coordinator: Rachel Scheperle, PhD
- Email: oto-electrophys@uiowa.edu
- Phone: 319-384-9031
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.