Evaluation of the Automated Integration of a Robotics and ECochG System for Use With Cochlear Implant Surgery

Launched by IOTAMOTION, INC. · Oct 28, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new system that combines robotics and a special hearing test called electrocochleography (ECochG) to improve the surgery for cochlear implants. Cochlear implants are devices that help people with severe hearing loss by directly stimulating the hearing nerve. The goal of this study is to see how well this new system works in making cochlear implant surgeries safer and more effective.

To join the trial, participants need to be at least 18 years old and be candidates for a cochlear implant in one or both ears. They should also have some remaining hearing that can be measured with ECochG. However, there are certain conditions that would exclude someone from participating, such as having a previous cochlear implant in the ear being treated or specific ear abnormalities. Those who take part in the trial will need to follow the study's requirements and will be monitored closely throughout the process. This study is not yet recruiting participants, but it aims to enhance cochlear implant surgery for future patients.

Gender

ALL

Eligibility 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