Evaluating the safety of the iotaSOFT Insertion System for cochlear implants
Post-Market Clinical Investigation of the IotaSOFT Insertion System for Use with Cochlear Implant Surgery
This study is testing the safety of a new tool for placing cochlear implants in people aged 12 and older with hearing loss to see how well it works and if it has any issues.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 12 Years and up |
| Sex | All |
| Sponsor | iotaMotion, Inc. Industry-sponsored |
| Locations | 3 sites (Indianapolis, Indiana and 2 other locations) |
| Trial ID | NCT06664697 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the safety of the iotaSOFT Insertion System used for inserting cochlear implant electrode arrays in patients aged 12 and older with sensorineural hearing loss. It will collect both retrospective and prospective safety data, focusing on procedural characteristics such as insertion speed and device deficiencies. The study will also evaluate the functionality of cochlear implants post-procedure to ensure effective use of the insertion system.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 12 years and older with sensorineural hearing loss who are undergoing unilateral or bilateral cochlear implantation.
Not a fit: Patients with prior cochlear implantation in the ear to be implanted or those with significant cochlear anomalies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the safety and effectiveness of cochlear implant procedures for patients with hearing loss.
How similar studies have performed: Other studies have shown success with similar robotic-assisted cochlear implantation approaches, indicating potential for positive outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Indianapolis, Indiana and 2 other locations
- Indiana University — Indianapolis, Indiana, United States (Recruiting)
- University of Iowa — Iowa City, Iowa, United States (Not_yet_recruiting)
- Oregon Health and Sciences University — Portland, Oregon, United States (Recruiting)
Study contacts
- Study coordinator: Laura Chenier, AuD
- Email: lchenier@iotamotion.com
- Phone: 442-325-4171
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.