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Procedure

iotaSOFT Device for Hearing Loss

N/A

Recruiting

Research Sponsored by iotaMotion, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days following surgery

Awards & highlights

Study Summary

This trial studies the safety and effectiveness of a device to help insert electrode arrays during cochlear implant surgery in children.

Who is the study for?

This trial is for children aged 9 months to less than 12 years who need cochlear implants due to hearing loss and can follow the study's schedule. It's not for kids who've had a cochlear implant before, have ear infections, certain ear abnormalities, or conditions that affect their participation as judged by the researcher.Check my eligibility

What is being tested?

The iotaSOFT Insertion System is being tested in this non-randomized, open-label study to see if it safely and effectively helps place electrode arrays during pediatric cochlear implant surgeries.See study design

What are the potential side effects?

While specific side effects are not listed here, potential risks may include those typically associated with surgical procedures such as infection, bleeding, or issues related to improper placement of the cochlear implant.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a candidate for a cochlear implant as per FDA guidelines.

Select...

I am between 9 months and 12 years old and need CI surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days following surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days following surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days following surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Safety related to adverse events

Trial Design

1Treatment groups

Experimental Treatment

Group I: Pediatric Cochlear Implant RecipientExperimental Treatment1 Intervention

Pediatric subjects receiving a cochlear implant between the ages of 9 months and under 12 years of age.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

iotaSOFT Insertion System

2020

N/A

~30

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

iotaMotion, Inc.Lead Sponsor

1 Previous Clinical Trials

25 Total Patients Enrolled

Laura ChenierStudy DirectoriotaMotion, Inc.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial provide an opportunity for adolescents to participate?

"Patients aged between 9 months and 12 years can participate in this trial."

Answered by AI

Who meets the criteria for participation in this trial?

"Those who seek to join this trial must between 9 Months and 12 years old, present with sensorineural hearing loss, and be one of the 20 participants accepted."

Answered by AI

How many applicants are being admitted into this research endeavor?

"Yes, the information posted on clinicaltrials.gov indicates that this clinical trial is actively enrolling. This medical study was initially posted on May 17th 2022 and subsequently updated October 24th 2023. There are currently 20 open slots for patients at a single site."

Answered by AI

Is the protocol presently open to participants?

"Affirmative. According to reports on clinicaltrials.gov, this study is currently collecting applicants for participation. It was originally posted on May 17th 2022 and the most recent update occurred October 24th 2023 - they are looking for a total of 20 test subjects from 1 medical facility."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

iotaSOFT Pediatric Study

2022. "iotaSOFT Pediatric Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06106373.

All > Sensorineural Hearing Loss