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

NCT06664710 | Recruiting FDA Device

• 1 other identifier: IAR2401
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hearing Loss, Sensorineural; Cochlear Implantation

Keywords

cochlear implantation; sensorineural hearing loss; robotics

Outcome Measures

Primary Outcomes (1)

• Device Feasibility

  Feasibility of device functionality intraoperatively at the time of cochlear implant surgery.

  Procedure Day 0

Study Arms (2)

Control

ACTIVE COMPARATOR

Use of the iotaSOFT Insertion System and AIM based on Standard of Care

Device: iotaSOFT Insertion System with AIM Control

Experimental

EXPERIMENTAL

Use of iotaSOFT Insertion System with AIM experimental device

Device: iotaSOFT Insertion System with AIM

Interventions

iotaSOFT Insertion System with AIM DEVICE

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

Experimental

iotaSOFT Insertion System with AIM Control DEVICE

iotaSOFT Insertion System with AIM using standard of care insertion techniques

Control

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Cochlear implant candidate in one or two ears per current FDA indications
• Sufficient residual hearing to support use of electrocochleography, as determined by the investigator
• Cochlear implantation using the Advanced Bionics SlimJ electrode array
• years of age or older at the time of enrollment
• Willingness to participate in and comply with all requirements of the protocol

You may not qualify if:

• 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.
• \. History of temporal bone fracture that involves the cochlea/internal auditory canal.
• \. Retrocochlear etiology (e.g. diagnosis of auditory neuropathy, cochlear nerve deficiency, or lesions of the acoustic nerve or central auditory pathway).
• \. Active middle-ear infection or tympanic membrane perforation in the presence of active middle ear disease.
• \. 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.
• \. Additional medical concerns that would prevent participation in evaluations as determined by the investigator.
• \. Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to the procedure and investigational device.
• \. Vulnerable subject, as per FDA regulations 21 CFR Parts 50 and 56

Sponsors & Collaborators

• iotaMotion, Inc.: lead

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

RECRUITING

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Laura Chenier, Director of Clinical Affairs, AuD

CONTACT

442-325-4171; lchenier@iotamotion.com

Costa Nikou

CONTACT

cnikou@iotamotion.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2024
• First Posted: October 29, 2024
• Study Start: January 17, 2024
• Primary Completion: August 30, 2025
• Study Completion: August 30, 2025
• Last Updated: May 1, 2025

Record last verified: 2025-01

Locations

US (1)