Post-Market Clinical Investigation of the IotaSOFT Insertion System (ACE)

Post-Market Clinical Investigation of the IotaSOFT Insertion System for Use with Cochlear Implant Surgery

The purpose of the proposed study is to evaluate the continued safety of the iotaSOFT Insertion System when used by a surgeon to assist with inserting a CI electrode array in one ear per subject

Study Overview

• Status: Recruiting
• Conditions: Hearing Loss, Sensorineural; Cochlear Implantation; Hearing Loss, Cochlear
• Intervention / Treatment: Device: Cochlear Implantation with Robotic-Assisted Insertion System

Detailed Description

available iotaSOFT Insertion System when used per intended use for insertion of a cochlear implant electrode array in subjects 12 years and older. The purpose of the study is to collect additional safety data in retrospective and prospective subjects. The primary object of the study is to demonstrate post-market safe use of the commercially available iotaSOFT Insertion System. The secondary objective of the study is to define procedural characteristics including device deficiencies, electrode array insertion speed, rate of tip fold-over, and objective measures of cochlear implant functionality to demonstrate effective use of the commercially available iotaSOFT Insertion System.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Laura Chenier, AuD; Phone Number: 442-325-4171; Email: lchenier@iotamotion.com
• Study Contact Backup: Name: Wade Colburn; Email: wcolburn@iotamotion.com

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Recruiting
      • Indiana University
      • Contact: Leila Partoo; Phone Number: 317-278-1238; Email: lpartoo@iu.edu
      • Contact: Rick Nelson, MD
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • Not yet recruiting
      • University of Iowa
      • Contact: Camille Dunn, AuD; Phone Number: 319-356-3574; Email: camille-dunn@uiowa.edu
      • Contact: Bruce Gantz, MD
  • Oregon
    • Portland, Oregon, United States, 97239
      • Recruiting
      • Oregon Health and Sciences University
      • Contact: Jess Mace; Phone Number: 503-494-5886; Email: macej@ohsu.edu
      • Contact: Jay Gantz, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

A minimum of 50 subjects with sensorineural hearing loss and who have received a cochlear implant using the commercially available iotaSOFT insertion system or are scheduled for unilateral or bilateral cochlear implant surgery will be enrolled, such that a minimum of 50 subjects/ears using iotaSOFT will be attempted

Description

Inclusion Criteria:

1. Candidates with sensorineural hearing loss who received or will receive unilateral or bilateral cochlear implantation according to indications for use with FDA approved cochlear implant devices, as listed below:

   1. Advanced Bionics HiFocus SlimJ
   2. Cochlear Slim Straight
   3. MED-EL Flex 24 and 28
2. Age 12 years or older at the time of CI surgery.
3. Willingness to participate in the study and able to comply with the follow-up visit requirements.

Exclusion Criteria:

1. Prior cochlear implantation in the ear to be implanted.
2. Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array or present an increased risk of aberrant insertion.
3. Craniofacial abnormality, temporal squamosal skull thickness less than 3mm, major cochlear lesions (e.g., fibrosis, fracture, or ossification), or cochlear malformations.
4. Deafness due to lesions of the acoustic nerve or central auditory pathway.
5. Diagnosis of auditory neuropathy.
6. Active middle-ear infection or tympanic membrane perforation in the presence of active middle ear disease.
7. Absence of cochlear development.
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. Non-native English speakers who are unable to read, understand and/or speak English for completion of required procedures
11. Planned or current participation in a clinical study of an investigational device or drug.
12. Must not fit the definition of a vulnerable subjects, as per FDA regulations 21 CFR Parts 50 and 56

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Retrospective; Retrospective Review of patient records	Device: Cochlear Implantation with Robotic-Assisted Insertion System; The purpose of the study is to collect additional safety data in retrospective and prospective subjects who receive a cochlear implant using the iotaSOFT Insertion System.
Prospective; Prospective data collection of subjects receiving a cochlear implant with robotic-assisted cochlear implant	Device: Cochlear Implantation with Robotic-Assisted Insertion System; The purpose of the study is to collect additional safety data in retrospective and prospective subjects who receive a cochlear implant using the iotaSOFT Insertion System.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects Experiencing a Serious or Related Adverse Event Due to Use of the iotaSOFT Insertion System During Cochlear Implant Surgery	Number of Subjects Experiencing a Serious or Related Adverse Event Due to Use of the iotaSOFT Insertion System During Cochlear Implant Surgery through 1 month post-operative follow-up	1 month post-activation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of device deficiencies related to the use of the iotaSOFT Insertion System	Number of reported device deficiencies related to the use of the iotaSOFT Insertion System at the time of cochlear implant surgery	1 month post-activation

Collaborators and Investigators

• Sponsor: iotaMotion, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Estimated): October 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: October 7, 2024
• First Submitted That Met QC Criteria: October 28, 2024
• First Posted (Actual): October 29, 2024

Study Record Updates

• Last Update Posted (Actual): October 31, 2024
• Last Update Submitted That Met QC Criteria: October 29, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: cochlear implantation; sensorineural hearing loss
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Hearing Disorders; Hearing Loss; Deafness; Hearing Loss, Sensorineural
• Other Study ID Numbers: ICI2401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Cohort data will be provided for analysis for publication and presentation and individual data points will be pulled for reporting requirements only. Primary and secondary endpoint data will be exported and analyzed for required reporting.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes