iotaSOFT Pediatric Study

Description

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.

Conditions

Hearing Loss, Sensorineural, Hearing Loss, Bilateral, Hearing Loss, Unilateral

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Study Overview

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Study Details

Study overview

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.

iotaSOFT Insertion System for Use With Cochlear Implant Surgery in Pediatrics

iotaSOFT Pediatric Study

Condition
Hearing Loss, Sensorineural
Intervention / Treatment

-

Contacts and Locations

Iowa City

University of Iowa, Iowa City, Iowa, United States, 52242

Houston

Texas Childrens Hospital, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

9 Months to 12 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

iotaMotion, Inc.,

Laura Chenier, STUDY_DIRECTOR, iotaMotion, Inc.

Study Record Dates

2024-12-01