What side effects are associated with this type of intervention?

Cochlear implants, a common treatment for Sensorineural Hearing Loss, can have several side effects. These include surgical risks such as infection, bleeding, and adverse reactions to anesthesia. Post-surgery, patients may experience dizziness, tinnitus, and changes in taste. There is also a risk of device malfunction or failure, which may require additional surgery. Long-term, some patients might face issues with balance and persistent ear discomfort.

What prior FDA approvals exist?

The FDA has approved several treatments for Sensorineural Hearing Loss, primarily focusing on cochlear implants. Cochlear implants are electronic devices that provide a sense of sound to individuals who are profoundly deaf or severely hard of hearing. These devices consist of an external portion that sits behind the ear and a second portion that is surgically placed under the skin. The iotaSOFT Insertion System is a recent innovation designed to assist in the precise insertion of the electrode array during cochlear implant surgery, enhancing the safety and efficacy of the procedure. While there are no specific drugs approved solely for the treatment of Sensorineural Hearing Loss, the focus remains on surgical and technological interventions like cochlear implants.

What other types of research exist?

Promising alternatives to the iotaSOFT Insertion System for cochlear implant surgery include the da Vinci Si-assisted cochlear implant procedure, which utilizes a master-slave robotic system for enhanced precision and minimally invasive surgery. Additionally, advancements in image-guided surgery with augmented reality and intraoperative cone beam computed tomography are also noteworthy. These technologies aim to improve surgical accuracy and patient outcomes in the treatment of sensorineural hearing loss.

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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

Must not have

Craniofacial abnormality, temporal squamosal skull thickness less than 3mm, major cochlear lesions, or cochlear malformations

Absence of cochlear development

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days following surgery

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new tool called the iotaSOFT Insertion System. It helps doctors insert tiny wires into the inner ear during cochlear implant surgery. The study focuses on children who need this surgery to improve their hearing. The goal is to see if this tool makes the procedure safer and more effective.

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.

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.

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

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a skull or inner ear abnormality.

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My inner ear has not developed properly.

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My hearing loss is due to nerve damage.

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I have been diagnosed with a hearing disorder where sound enters normally but has trouble being sent to my brain.

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I currently have an ear infection or a hole in my eardrum with an active ear disease.

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My inner ear structure may not allow complete or safe placement of a hearing device.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety related to adverse events

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Sensorineural Hearing Loss (SNHL) include hearing aids and cochlear implants. Hearing aids amplify sound to make it easier for damaged ears to detect, while cochlear implants bypass damaged parts of the ear and directly stimulate the auditory nerve using electrical signals. The iotaSOFT Insertion System assists in the precise placement of the electrode array during cochlear implant surgery, which is crucial for optimal performance of the implant. Understanding these mechanisms is important for SNHL patients as it helps them make informed decisions about their treatment options, ensuring they choose the most effective method to improve their hearing and quality of life.