RECRUITING

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

Conditions

Hearing Loss, Sensorineural Cochlear Implantation sensorineural hearing loss robotics

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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

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

Official Title

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

Quick Facts

Study Start:2024-01-17

Study Completion:2025-08-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06664710

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. 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	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

Inclusion Criteria

Exclusion 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

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

Contacts and Locations

Study Contact

Laura Chenier, Director of Clinical Affairs, AuD

CONTACT

442-325-4171

lchenier@iotamotion.com

Costa Nikou

CONTACT

cnikou@iotamotion.com

Study Locations (Sites)

University of Iowa

Iowa City, Iowa, 52242

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 Date2024-01-17

Study Completion Date2025-08-30

Study Record Updates

Study Start Date2024-01-17

Study Completion Date2025-08-30

Terms related to this study

Keywords Provided by Researchers

cochlear implantation
sensorineural hearing loss
robotics

Additional Relevant MeSH Terms

Hearing Loss, Sensorineural
Cochlear Implantation