RECRUITING

Post-Market Clinical Investigation of the IotaSOFT Insertion System

Conditions

Hearing Loss, Cochlear Cochlear Implantation Hearing Loss, Sensorineural sensorineural hearing loss

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2024-10-01

Study Completion:2025-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06664697

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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

Inclusion Criteria

Exclusion 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.

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

Contacts and Locations

Study Contact

Laura Chenier, AuD

CONTACT

442-325-4171

lchenier@iotamotion.com

Wade Colburn

CONTACT

wcolburn@iotamotion.com

Study Locations (Sites)

Indiana University

Indianapolis, Indiana, 46202

United States

University of Iowa

Iowa City, Iowa, 52242

United States

Oregon Health and Sciences University

Portland, Oregon, 97239

United States

Collaborators and Investigators

Sponsor: iotaMotion, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-01

Study Completion Date2025-12-31

Study Record Updates

Study Start Date2024-10-01

Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

cochlear implantation
sensorineural hearing loss

Additional Relevant MeSH Terms

Hearing Loss, Cochlear
Cochlear Implantation
Hearing Loss, Sensorineural