30 Participants Needed

Opto-electrical Stimulation for Hearing Loss

(oCI Trial)

Recruiting at 2 trial locations
CR
Overseen ByClaus-Peter Richter, MD, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Northwestern University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

Neural stimulation with photons has been proposed for a next generation of cochlear implants (CIs). The potential benefit of photonic over electrical stimulation is its spatially selective activation of small populations of spiral ganglion neurons (SGNs). Stimulating smaller neuron populations along the cochlea provides a larger number of independent channels to encode acoustic information. Hearing could therefore be restored at a higher fidelity and performance in noisy listening environments as well as music appreciation are likely to improve . While it has been demonstrated that optical radiation evokes auditory responses in animal models, it is not clear whether the radiant exposures used in the animal experiments are sufficient to stimulate the auditory system of humans. The proposed tests are: 1. to demonstrate that light delivery systems (LDSs) can be inserted and oriented optimally in the human cochlea. 2. to show that the LDSs are able to deliver sufficient amount of energy to evoke a compound action potential of the auditory nerve. 3. to validate that the fluence rate (energy / target area) required for stimulation is below the maximal fluence rate, which damaged the cochlea in animal experiments. 4. to show that combined optical and electrical stimulation is able to significantly lower the threshold required for optical stimulation in humans. The endpoints for the study are either the completion of the experiments proposed or the demonstration that not sufficient energy can be delivered safely in the human cochlea to develop an action potential.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Opto-electrical Cochlear Implants for hearing loss?

Research on electroacoustic stimulation (EAS) and cochlear implants shows that combining electrical and acoustic hearing can improve hearing outcomes, suggesting that similar approaches like opto-electrical stimulation might also be effective.12345

Is opto-electrical stimulation for hearing loss safe for humans?

Cochlear implants, which are similar devices, have been used safely in many people, including young children, for over 25 years. However, like any medical device, there is a risk of device failure and complications, which have been studied to improve safety.678910

How does the Opto-electrical Cochlear Implant treatment differ from other treatments for hearing loss?

The Opto-electrical Cochlear Implant treatment is unique because it uses light, rather than electricity, to stimulate the auditory nerve, allowing for more precise sound encoding and potentially better speech recognition in noisy environments compared to traditional electrical cochlear implants.1112131415

Research Team

CR

Claus-Peter Richter, MD, PhD

Principal Investigator

Northwestern University

Eligibility Criteria

This trial is for adults who need surgery to remove a tumor near the facial nerve, which requires accessing the inner ear. They should have significant hearing loss (50 dB or more) and poor speech discrimination (50% or less). It's not open to those unable to consent, minors, pregnant women, prisoners, or vulnerable groups.

Inclusion Criteria

Your hearing loss is severe, with a significant increase in the ability to hear quiet sounds.
My surgery will involve accessing the tumor through the inner ear.
You understand less than half of what is being said to you.
See 2 more

Exclusion Criteria

Prisoners
I am unable to give consent for myself.
Pregnant women
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Insertion of light delivery systems into the cochlea and measurement of auditory responses during tumor surgery

30 minutes
1 visit (in-person, during surgery)

Follow-up

No follow-up required as per trial description

Treatment Details

Interventions

  • Opto-electrical Cochlear Implants
Trial OverviewThe study tests new cochlear implants that use light (photons) for potentially better hearing restoration. It aims to insert light delivery systems in the human cochlea safely and check if they can stimulate auditory nerves without damage. The trial also explores whether combining light with electrical stimulation lowers the energy needed.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: electrical and optical hybrid stimulation stimulationExperimental Treatment3 Interventions
Patients with large tumors of the skull base, requiring a translabyrinthine craniotomy with sacrifice of their cochlea and vestibular system during the tumor resection may participate. A recording electrode will be placed on the round window, a cochleostomy will be created, and different Light delivery systems (LDSs) will be inserted into the cochlea. LDSs include angle polished optical fibers to determine the accuracy of the orientation of the radiation beam, and hybrid arrays of small optical sources and electrical contacts to evaluate electric-alone stimulation as a reference, and compare it to optic-alone and combined electrical and optical stimulation. Compound action potentials (CAPs) of the auditory nerve will be recorded.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials
1,674
Recruited
989,000+

Central DuPage Hospital

Collaborator

Trials
15
Recruited
3,900+

University of Miami

Collaborator

Trials
976
Recruited
423,000+

University of Missouri-Columbia

Collaborator

Trials
387
Recruited
629,000+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials
377
Recruited
190,000+

Findings from Research

In a study of 17 children with limited low-frequency hearing who underwent cochlear implantation (CI), electroacoustic stimulation (EAS) rehabilitation showed potential benefits, particularly in noisy environments, enhancing speech perception compared to CI-only mode.
Successful EAS rehabilitation was achieved in 9 out of 21 ears, with the postoperative low-frequency pure-tone average identified as a key predictive factor for better outcomes, suggesting that preserving low-frequency hearing during CI can improve auditory rehabilitation.
Outcomes and Predictive Factors of Electroacoustic Stimulation Rehabilitation in Children With Limited Low-Frequency Hearing.Nam, GS., Song, MH., Choi, JY., et al.[2020]
In a study involving 16 adults with post-linguistic hearing impairment, access to bilateral acoustic hearing alongside cochlear implant stimulation significantly improved speech recognition in noisy environments, localization abilities, and subjective ratings of real-world benefits.
The findings suggest that combining acoustic hearing in both ears with electrical stimulation from a cochlear implant enhances overall hearing performance, indicating a strong advantage for patients with this configuration.
Utility of bilateral acoustic hearing in combination with electrical stimulation provided by the cochlear implant.Plant, K., Babic, L.[2017]
In a study of 7356 patients with hearing impairment, only 0.71% were found to be candidates for electric-acoustic stimulation (EAS) implants, compared to 2.52% for standard cochlear implants (CIs).
Among the EAS candidates, only 5.83% (2 individuals) actually received the EAS implant surgery, highlighting the need for healthcare professionals to thoroughly evaluate patients with high-frequency hearing loss for potential EAS eligibility.
Prevalence of potential candidates for electric-acoustic stimulation implant in a hearing-impaired population.Saito, K., Fujita, T., Osaki, Y., et al.[2021]

References

Outcomes and Predictive Factors of Electroacoustic Stimulation Rehabilitation in Children With Limited Low-Frequency Hearing. [2020]
Utility of bilateral acoustic hearing in combination with electrical stimulation provided by the cochlear implant. [2017]
Multichannel cochlear implantation in visually impaired patients. [2019]
Prevalence of potential candidates for electric-acoustic stimulation implant in a hearing-impaired population. [2021]
Cochlear Implant Outcomes in Patients With Severe Compared With Profound Hearing Loss. [2021]
A review of device failure in more than 23 years of clinical experience of a cochlear implant program with more than 3,400 implantees. [2022]
HiRes ultra series cochlear implant field recall: failure rates and early outcomes. [2023]
Multicenter study with a direct acoustic cochlear implant. [2022]
Complications of cochlear implants: a MAUDE database study. [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
Trends in cochlear implant complications: implications for improving long-term outcomes. [2013]
Considering optogenetic stimulation for cochlear implants. [2022]
μLED-based optical cochlear implants for spectrally selective activation of the auditory nerve. [2021]
Shedding light on optical cochlear implant progress. [2023]
14.United Statespubmed.ncbi.nlm.nih.gov
Towards optogenetic approaches for hearing restoration. [2021]
15.United Statespubmed.ncbi.nlm.nih.gov
Optoacoustically induced auditory brainstem responses in the mouse model enhanced through an absorbing film. [2021]