iotaSOFT Device for Hearing Loss

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

20 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the iotaSOFT Insertion System treatment for hearing loss?

Research on implantable hearing systems, like cochlear implants, shows they can significantly improve hearing in patients with severe hearing loss compared to traditional hearing aids. This suggests that similar implantable systems, such as the iotaSOFT Insertion System, may also be effective in treating hearing loss. ^{1 2 3 4 5}

What safety data exists for the iotaSOFT Device for Hearing Loss?

The safety of hearing devices, like cochlear implants and middle ear implants, has been evaluated in various studies. These studies generally focus on the safety and reliability of the devices over time, highlighting the importance of monitoring adverse events and ensuring long-term safety. While specific data on the iotaSOFT Device is not available, these studies suggest that safety evaluations are a critical part of the development and monitoring of hearing devices. ^{6 7 8 9 10}

How does the iotaSOFT Insertion System treatment for hearing loss differ from other treatments?

The iotaSOFT Insertion System is unique because it likely involves a novel method of delivering sound to the ear, potentially using advanced technology like MEMS (Micro-Electromechanical Systems) for precise sound processing and delivery, which may differ from traditional hearing aids or cochlear implants that rely on external sound processors. ^{5 11 12 13 14}

Research Team

Laura Chenier

Principal Investigator

iotaMotion, Inc.

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

[Audiological target parameters in clinical studies with implantable hearing systems]. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Experience with the SOUNDTEC implantable hearing aid. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Hearing Loss: Hearing Augmentation. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Device profile of the MED-EL cochlear implant system for hearing loss: overview of its safety and efficacy. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Clinical outcomes with the Kanso™ off-the-ear cochlear implant sound processor. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Trends in cochlear implant complications: implications for improving long-term outcomes. [2013]

7. United States pubmed.ncbi.nlm.nih.gov

Otologics fully implantable hearing system: Phase I trial 1-year results. [2015]

8. United States pubmed.ncbi.nlm.nih.gov

Totally implantable active middle ear implant: Hearing and safety results in a large series. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

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

10. New Zealand pubmed.ncbi.nlm.nih.gov

Evaluating the Safety Profile of Non-Active Implantable Medical Devices Compared with Medicines. [2018]

11. England pubmed.ncbi.nlm.nih.gov

Initial experiments to develop a MEMS transducer for a new implantable audioprosthesis to substitute the tympanic-ossicular system. [2007]

12. France pubmed.ncbi.nlm.nih.gov

[Presentation of a 16-filter hearing aid with selective amplification and compression]. [2008]

13. Netherlands pubmed.ncbi.nlm.nih.gov

[Hearing impairment fitting: study of an auditory prosthesis with 7 entirely programmable filters]. [2006]

14. France pubmed.ncbi.nlm.nih.gov

[Implants for the middle ear, development of a human prototype]. [2006]