iotaSOFT Pediatric Study

iotaMotion

Status

Completed

Conditions

Hearing Loss, Bilateral

Hearing Loss, Unilateral

Hearing Loss, Sensorineural

Treatments

Device: iotaSOFT Insertion System

Study type

Interventional

Funder types

Industry

Identifiers

NCT06106373

iotaSOFT000002

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

All

Ages

9 months to 12 years old

Volunteers

Accepts Healthy Volunteers

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