Using robotics and electrocochleography for cochlear implant surgery
Evaluation of the Automated Integration of a Robotics and ECochG System for Use With Cochlear Implant Surgery
This study is testing if using a robotic system during cochlear implant surgery can help improve outcomes for people with hearing loss.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 12 Years and up |
| Sex | All |
| Sponsor | iotaMotion, Inc. Industry-sponsored |
| Locations | 1 site (Iowa City, Iowa) |
| Trial ID | NCT06664710 on ClinicalTrials.gov |
What this trial studies
This study evaluates the feasibility and proof of concept for integrating a robotic system with electrocochleography (ECochG) during cochlear implantation. The aim is to assess the effectiveness of the AIM System and iotaSOFT Insertion System in improving surgical outcomes for patients with sensorineural hearing loss. By collecting data on this integration, the study seeks to inform future clinical investigations in robotic-assisted cochlear implantation. Participants will undergo cochlear implantation using the Advanced Bionics SlimJ electrode array.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are cochlear implant candidates with sufficient residual hearing.
Not a fit: Patients with contraindications for cochlear implants or those with significant cochlear abnormalities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the precision and outcomes of cochlear implant surgeries for patients with hearing loss.
How similar studies have performed: While this approach is innovative, similar studies integrating robotics in surgical procedures have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Cochlear implant candidate in one or two ears per current FDA indications 2. Sufficient residual hearing to support use of electrocochleography, as determined by the investigator 3. Cochlear implantation using the Advanced Bionics SlimJ electrode array 4. 18 years of age or older at the time of enrollment 5. Willingness to participate in and comply with all requirements of the protocol Exclusion Criteria: Contraindications for a CI. 2. Prior cochlear implantation in the ear to be implanted. 3. Cochlear ossification or malformation (including but not limited to dysplasia or common cavity), craniofacial abnormality or any other structural cochlear abnormality that might prevent complete insertion of the electrode array or present an increased risk of aberrant insertion. 4\. History of temporal bone fracture that involves the cochlea/internal auditory canal. 5\. Retrocochlear etiology (e.g. diagnosis of auditory neuropathy, cochlear nerve deficiency, or lesions of the acoustic nerve or central auditory pathway). 6\. Active middle-ear infection or tympanic membrane perforation in the presence of active middle ear disease. 7\. Planned or current participation in a clinical study of an investigational device or drug that may impact data collection or outcomes related to this investigation. 8\. Additional medical concerns that would prevent participation in evaluations as determined by the investigator. 9\. Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to the procedure and investigational device. 10\. Vulnerable subject, as per FDA regulations 21 CFR Parts 50 and 56
Where this trial is running
Iowa City, Iowa
- University of Iowa — Iowa City, Iowa, United States (Recruiting)
Study contacts
- Study coordinator: Laura Chenier, Director of Clinical Affairs, AuD
- Email: lchenier@iotamotion.com
- Phone: 442-325-4171
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.