NCT06664697 Post-Market Clinical Investigation of the IotaSOFT Insertion System
| NCT ID | NCT06664697 |
| Status | Recruiting |
| Phase | — |
| Sponsor | iotaMotion, Inc. |
| Condition | Hearing Loss, Cochlear |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-10-01 |
| Primary Completion | 2025-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2024-10-01 with a primary completion date of 2025-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06664697 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, studying Hearing Loss, Cochlear. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06664697 currently recruiting?
Yes, NCT06664697 is actively recruiting participants. Contact the research team at lchenier@iotamotion.com for enrollment information.
Where is the NCT06664697 trial being conducted?
This trial is being conducted at Indianapolis, United States, Iowa City, United States, Portland, United States.
Who is sponsoring the NCT06664697 clinical trial?
NCT06664697 is sponsored by iotaMotion, Inc.. The trial plans to enroll 50 participants.