Ireland
--:--IST
Recruiting Not applicable

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

NCT06664710 · tracked via the Priya Life Science USA tracker
Sponsor
iotaMotion, Inc
Phase
Not applicable
Started
2024-01-17
Last updated
2025-05-01

Condition(s) studied

Hearing Loss, SensorineuralCochlear Implantation

Investigational drug(s) / intervention(s)

iotaSOFT Insertion System with AIMiotaSOFT Insertion System with AIM Control

iotaSOFT Insertion System with AIM: Experimental subjects will receive the iotaSOFT Insertion System with AIM using robotic controlled stop

iotaSOFT Insertion System with AIM Control: iotaSOFT Insertion System with AIM using standard of care insertion techniques

Study summary

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

Eligibility

Sex
ALL
Min age
12 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Device Feasibility — Procedure Day 0
    Feasibility of device functionality intraoperatively at the time of cochlear implant surgery.

Trial sites (1)

FacilityCityRegionStatus
University of Iowa Iowa City Iowa Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06664710 on ClinicalTrials.gov ↗ ← All trials in the USA