iotaSOFT Device for Hearing Loss

No longer recruiting at 1 trial location

Overseen By Wade Colburn

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: iotaMotion, Inc.

Disqualifiers: Prior cochlear implantation, Cochlear anomaly, Craniofacial abnormality, Auditory neuropathy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and effectiveness of the iotaSOFT Insertion System during cochlear implant surgeries for children. The device assists in inserting the electrode array, which interacts with the inner ear to improve hearing. It is designed for children who are candidates for cochlear implants and have not previously received one. Children with specific ear conditions or other medical issues that could complicate the surgery are not eligible.

As an unphased trial, this study offers a unique opportunity for children to potentially benefit from innovative technology in cochlear implant procedures.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that the iotaSOFT Insertion System is safe for pediatric cochlear implant surgery?

Research has shown that the iotaSOFT Insertion System, used in cochlear implant surgeries, is safe for people. Past studies successfully used this system to place electrode arrays without major problems. The FDA reviewed data supporting its safe use in these surgeries.

Although researchers continue to study the device, these reviews and studies suggest it is well-tolerated. Earlier trials reported no serious side effects, indicating they are unlikely. This makes the iotaSOFT Insertion System a promising tool for improving cochlear implant surgeries in children. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The iotaSOFT Insertion System is unique because it offers a novel approach to cochlear implant procedures for children with hearing loss. Traditional cochlear implants often require delicate and complex surgical techniques, but the iotaSOFT system aims to simplify the insertion process, potentially reducing surgery time and risk. Researchers are excited about this treatment because it could make cochlear implants more accessible and safer for young children, enhancing their chances for improved hearing and development.

What evidence suggests that the iotaSOFT Insertion System is effective for hearing loss?

Research shows that the iotaSOFT Insertion System eases the insertion of electrode arrays during cochlear implant surgery. Studies suggest that this robot-assisted method may preserve existing hearing levels while improving overall hearing. Past research supports the idea that iotaSOFT can make cochlear implant procedures safer and more effective. The technology aims to provide consistent results, benefiting every patient. This trial is currently evaluating the system's safety and effectiveness in cochlear implant surgeries, particularly for improving hearing in individuals with severe hearing loss. ^{1 2 4 6 7}

Who Is on the Research Team?

Laura Chenier

Principal Investigator

iotaMotion, Inc.

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Willingness to participate in the study and able to comply with the follow-up visit requirements

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

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

Exclusion Criteria

I have a skull or inner ear abnormality.

My inner ear has not developed properly.

My hearing loss is due to nerve damage.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo cochlear implant surgery using the iotaSOFT Insertion System

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after surgery

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• iotaSOFT Insertion System

Trial Overview

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.

How Is the Trial Designed?

Group I: Pediatric Cochlear Implant Recipient Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

iotaMotion, Inc.

Lead Sponsor

Trials

4

Recruited

110+

Published Research Related to This Trial

This study introduces a new evaluation protocol for research platforms (RPs) used in cochlear implants (CIs) and hearing aids (HAs) to ensure their operational safety and reliability, which is crucial for advancing hearing restoration technologies.

The proposed two-phase analysis includes an acoustic phase to assess sound output safety and a parameter phase to evaluate the reliability of electrical stimulation, providing a structured approach to improve the design and testing of hearing devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An evaluation framework for research platforms to advance cochlear implant/hearing aid technology: A case study with CCi-MOBILE. Shekar, RCMC., Hansen, JHL.[2022]

Cochlear implants (CIs) provide significantly better hearing improvement for patients with severe to profound hearing loss compared to conventional hearing aids, making them a more effective treatment option.

The MED-EL multichannel CI system has shown high reliability, with no technical failures reported over a 5-year observation period, highlighting the advancements in implant technology and design.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Device profile of the MED-EL cochlear implant system for hearing loss: overview of its safety and efficacy. Baumann, U., Stöver, T., Weißgerber, T.[2022]

A retrospective analysis of cochlear implant adverse events over a 10-year period revealed a significant increase in cases with multiple or unknown causes, particularly gradual idiopathic loss of performance, indicating a shift in the nature of reported issues.

Despite improvements in manufacturing and surgical techniques, the rise in complex adverse events suggests a need for further research to understand and address these idiopathic cases to enhance cochlear implant outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trends in cochlear implant complications: implications for improving long-term outcomes. Causon, A., Verschuur, C., Newman, TA.[2013]

The Otologics fully implantable hearing system demonstrated safety and effectiveness in providing sound amplification for patients with moderate to severe sensorineural hearing loss, with performance comparable to traditional hearing aids after one year of use.

While there were some adverse effects, including device extrusions and communication loss, most issues were resolved by the time of activation, indicating that the device can be a viable option for patients seeking an implantable solution.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Otologics fully implantable hearing system: Phase I trial 1-year results. Jenkins, HA., Atkins, JS., Horlbeck, D., et al.[2015]

There is a significant gap in the safety evaluation of non-active implantable medical devices (NAIMDs) compared to medicines, particularly in the absence of a global program for collecting and analyzing adverse events and product quality issues.

Adopting methodologies from drug safety evaluations, such as utilizing real-world data sources like electronic health records and implementing unique device identifiers (UDI), could enhance the ongoing monitoring and assessment of NAIMD safety throughout their entire life cycle.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the Safety Profile of Non-Active Implantable Medical Devices Compared with Medicines. Pane, J., Coloma, PM., Verhamme, KM., et al.[2018]

Citations

1.

iotamotion.com

iotamotion.com/

iotaMotion: Cochlear Implant Insertion Technology Simplified

Intuitive cochlear implant insertion technology to improve standardized outcomes for every patient and every procedure. Learn more here.

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04577118

NCT04577118 | The iotaSOFT Insertion System Safety Study

This is a confirmatory study to assess successful peri-procedural use of the iotaSOFT Insertion System and potential adverse events that may be caused by use of ...

3.

accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/reviews/DEN190055.pdf

DEN190055 Decision Summary - accessdata.fda.gov

Data was provided to support the safe and effective use of iotaSOFT to assist in the insertion of the above cochlear implant electrode arrays (i.e., cochlear ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12576857/

Robotic-Assisted Electrode Array Insertion Improves Rates ...

Robotic-assisted electrode array (EA) insertion is a promising technique that may enhance hearing preservation in cochlear implant (CI) surgery.

5.

withpower.com

withpower.com/trial/phase-hearing-loss-4-2022-7f23a

iotaSOFT Device for Hearing Loss · Info for Participants

Research on implantable hearing systems, like cochlear implants, shows they can significantly improve hearing in patients with severe hearing loss compared to ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9757840/

A Steadier Hand: The First Human Clinical Trial of a Single ...

This study evaluated the safety and utility of the robotic-assisted insertion system by measuring cochlear implant electrode array insertion ...

7.

trialx.com

trialx.com/clinical-trials/listings/268704/iotasoft-pediatric-study/

iotaSOFT Pediatric Study | Clinical Research Trial Listing ...

Prospective, non-randomized, open-label study to evaluate the safety and efficacy of the iotaSOFT Insertion System when used to assist electrode ...