N/A
N=25
The iotaSOFT Insertion System Safety Study
Cochlear Implant
Bottom Line
View on ClinicalTrials.gov: NCT04577118 ↗Enrolled (actual)
25
Serious AEs
9.5%
Results posted
Mar 2024
Primary outcome: Primary: Number of Subjects Experiencing a Peri-procedural Adverse Event Due to Use of the iotaSOFT Insertion System During Cochlear Implant Surgery — 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- iotaSOFT Insertion System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- iotaMotion, Inc.
- Primary completion
- Apr 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Experiencing a Peri-procedural Adverse Event Due to Use of the iotaSOFT Insertion System During Cochlear Implant Surgery |
2 | — |
| SECONDARY Successful Surgical Use of the iotaSOFT Insertion System During Cochlear Implant Surgery as Measured by a Surgeon Utility Questionnaire. The Questionnaire Will be Used to Calculate the Proportion of Subjects in Which the Device Performed as Intended. |
21 | — |
Summary
Non-significant risk evaluation of the iotaSOFT Insertion System when used by a surgeon to assist with inserting a cochlear implant electrode array.
Eligibility Criteria
Key Inclusion Criteria
- Candidate for cochlear implantation per indications
- Age 18 years or older
Key Exclusion Criteria
- Prior cochlear implantation in ear to be treated
- Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode ray
- Craniofacial abnormality or abnormal cochlear/nerve anatomy on pre-operative CT or MR imaging
- Deafness due to lesions of the acoustic nerve or central auditory pathway
- Diagnosis of auditory neuropathy
- Active middle ear infection
Data sourced from ClinicalTrials.gov (NCT04577118). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.