Hearing Loss, Bilateral, Hearing Loss, Sensorineural, Hearing Loss, Unilateral
Conditions
Brief summary
Prospective, non-randomized, open-label study to evaluate the safety and efficacy of the iotaSOFT Insertion System when used to assist electrode array insertion during cochlear implant surgery in a pediatric population.
Interventions
robotic assistive technology for cochlear implant electrode insertion
Sponsors
iotaMotion, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
9 Months to 12 Years
Healthy volunteers
Yes
Inclusion criteria
* Candidate for unilateral or bilateral cochlear implantation according to indications for use with FDA approved cochlear implant devices * Age 9 months to less than 12 years old at the time of CI surgery * Willingness to participate in the study and able to comply with the follow-up visit requirements
Exclusion criteria
* Prior cochlear implantation in the ear to be implanted * Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array or present an increased risk of aberrant insertion * Craniofacial abnormality, temporal squamosal skull thickness less than 3mm, major cochlear lesions, or cochlear malformations * Deafness due to lesions of the acoustic nerve or central auditory pathway * Diagnosis of auditory neuropathy. * Active middle-ear infection or tympanic membrane perforation in the presence of active middle-ear disease * Absence of cochlear development * Additional medical concerns that would prevent participation in evaluations as determined by the investigator * Planned or current participation in a clinical study of an investigational device or drug
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| iotaSOFT Related-serious Adverse Events Measured by Calculating the Proportion of Subjects With One or More SAEs. | (SAEs) through 30 days after CI surgery/activation | The primary endpoint of the study was to demonstrate safety of the iotaSOFT Insertion System through evaluation of iotaSOFT related serious adverse events through 30 days after CI surgery/activation. |
Countries
United States
Contacts
STUDY_DIRECTORLaura Chenier
iotaMotion, Inc.
Participant flow
Recruitment details
Study participants were identified and recruited by investigators from IDE/IRB-approved investigator sites. Those recruited were pediatric cochlear implant candidates pending implantation with one of the protocol-identified iotaSOFT-compatible electrode arrays.
Pre-assignment details
20 study participants were enrolled and received the investigational intervention.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 5.7 years |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 6 / 20 |
| serious Total, serious adverse events | 1 / 20 |
Outcome results
None listed