Post-Market Clinical Investigation of the IotaSOFT Insertion System

NCT06664697 | Recruiting FDA Device

• 1 other identifier: ICI2401
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Hearing Loss, Cochlear; Cochlear Implantation; Hearing Loss, Sensorineural

Keywords

cochlear implantation; sensorineural hearing loss

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of device deficiencies related to the use of the iotaSOFT Insertion System

  1 month post-activation

Study Arms (2)

Retrospective

Retrospective Review of patient records

Device: Cochlear Implantation with Robotic-Assisted 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

Interventions

Cochlear Implantation with Robotic-Assisted Insertion System DEVICE

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; Retrospective

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• iotaMotion, Inc.: lead

Study Sites (3)

Indiana University

Indianapolis, Indiana, 46202, United States

RECRUITING

University of Iowa

Iowa City, Iowa, 52242, United States

NOT YET RECRUITING

Oregon Health and Sciences University

Portland, Oregon, 97239, United States

RECRUITING

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Interventions

Cochlear Implantation

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

Intervention Hierarchy (Ancestors)

Otologic Surgical Procedures; Otorhinolaryngologic Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation

Central Study Contacts

Laura Chenier, AuD

CONTACT

442-325-4171; lchenier@iotamotion.com

Wade Colburn

CONTACT

wcolburn@iotamotion.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2024
• First Posted: October 29, 2024
• Study Start: October 1, 2024
• Primary Completion: October 31, 2025
• Study Completion: December 31, 2025
• Last Updated: October 31, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

US (3)