Opto-electrical Stimulation for Hearing Loss

(oCI Trial)

Enrolling by invitation at 2 trial locations

Overseen By Claus-Peter Richter, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Pregnancy, Minors, Prisoners, others

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

Compensation: Varies

Number of Visits: 1

Duration: 30 minutes

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new cochlear implant that uses both light and electricity to enhance hearing. The aim is to determine if this method can improve hearing quality, particularly in noisy environments or while enjoying music. Researchers are testing whether light-based stimulation can activate hearing nerves in humans as it does in animals. The trial seeks participants who require tumor surgery affecting their hearing and have significant hearing loss. Participants will help researchers assess the safety and effectiveness of this new implant approach. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could revolutionize hearing restoration techniques.

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 prior data suggests that this opto-electrical cochlear implant is safe for humans?

Research shows that new cochlear implants using both light and electrical signals are being tested to improve hearing. These implants aim to stimulate the hearing nerve with light and electricity. While this method remains under study, current cochlear implants using only electrical signals are widely used and generally safe for severe hearing loss.

A key safety concern involves ensuring the light in these new implants doesn't harm the ear. In animal studies, researchers found that the light levels needed to aid hearing were safe. However, these findings require confirmation in humans. Previous studies suggest that combining light and electrical signals might reduce the necessary light amount, potentially enhancing implant safety.

Although the current trial phase doesn't yet provide clear safety data, the research aims to ensure the procedure is safe for people. Since cochlear implants are already approved for other uses, there is some confidence in this new approach. However, data from these trials will be essential to fully understand the safety of the new light-and-electricity method. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about opto-electrical cochlear implants because they offer a novel way to stimulate the auditory nerve. Unlike traditional cochlear implants that rely solely on electrical stimulation, these new implants combine both optical and electrical methods. This hybrid approach could provide more precise stimulation, potentially leading to better hearing outcomes for patients, especially those with complex cases involving large skull base tumors. By accurately targeting the auditory nerve, researchers hope to enhance hearing clarity and quality, opening up new possibilities for people who haven't benefited fully from existing treatments.

What evidence suggests that opto-electrical cochlear implants could be effective for hearing loss?

Research has shown that opto-electrical cochlear implants, which participants in this trial will receive, might improve hearing by using light to stimulate the hearing nerve. Animal studies found that light can activate nerve cells more precisely than traditional implants, potentially leading to better sound quality. This precise activation is expected to help people hear better in noisy environments and enjoy music more. The implants in this trial aim to use both light and electrical signals to work more efficiently. These findings suggest that opto-electrical cochlear implants could be a promising option for improved hearing restoration. ^{1 2 4 5 6}

Who Is on the Research Team?

Claus-Peter Richter, MD, PhD

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

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.

Exclusion Criteria

Prisoners

I am unable to give consent for myself.

Pregnant women

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Opto-electrical Cochlear Implants

Trial Overview The 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.

How Is the Trial Designed?

Group I: electrical and optical hybrid stimulation stimulation Experimental Treatment 3 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.

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+

Published Research Related to This Trial

A study of 3,417 cochlear implant recipients over 23 years revealed that the cumulative survival rates (CSRs) for cochlear implants vary significantly between different models and brands, particularly at the 6-year mark.

Common causes of device failure include impact, electronic dysfunction, and leakage, but explant-reimplant procedures are considered safe and effective for addressing these failures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of device failure in more than 23 years of clinical experience of a cochlear implant program with more than 3,400 implantees. Battmer, RD., Linz, B., Lenarz, 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]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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 of 113 patients with Advanced Bionics Ultra cochlear implants, 17.7% experienced device failure, primarily in children, highlighting the need for ongoing monitoring of at-risk devices.

After revision surgeries, patients generally maintained stable auditory performance, indicating that revision procedures are effective and safe, with most patients opting to stay with the same manufacturer for their new devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HiRes ultra series cochlear implant field recall: failure rates and early outcomes. Winchester, A., Kay-Rivest, E., Friedmann, DR., et al.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utility of bilateral acoustic hearing in combination with electrical stimulation provided by the cochlear implant. Plant, K., Babic, L.[2017]

The study involved 15 patients with severe-to-profound mixed hearing loss and demonstrated that the Codacs direct acoustic cochlear implant significantly improved sound field thresholds by an average of 48 dB after 3 months of activation.

Patients also showed substantial improvements in word recognition scores, with increases of up to 78.2%, and a 27% reduction in hearing difficulty, indicating the device's efficacy in enhancing hearing capabilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multicenter study with a direct acoustic cochlear implant. Lenarz, T., Zwartenkot, JW., Stieger, C., et al.[2022]

A review of 31,857 adverse events from cochlear implants revealed that implants from manufacturer C had a higher incidence of complications, including infection (0.97%), cerebrospinal fluid leak (0.07%), extrusion (0.44%), and facial nerve stimulation (0.11%).

Manufacturer B's implants were linked to a higher rate of meningitis (0.07%), highlighting the importance of considering both patient risk factors and the specific manufacturer when evaluating the safety of cochlear implants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications of cochlear implants: a MAUDE database study. Jinka, S., Wase, S., Jeyakumar, A.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence of potential candidates for electric-acoustic stimulation implant in a hearing-impaired population. Saito, K., Fujita, T., Osaki, Y., et al.[2021]

Optogenetic stimulation using multi-channel optical cochlear implants (oCIs) can provide high spectral selectivity in activating the auditory nerve, which may improve speech recognition in noisy environments compared to traditional electrical cochlear implants (eCIs).

In a study involving adult Mongolian gerbils, the oCIs demonstrated effective tonotopic activation of the auditory pathway with modest power requirements, indicating their potential for restoring hearing in both hearing and deaf subjects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

μLED-based optical cochlear implants for spectrally selective activation of the auditory nerve. Dieter, A., Klein, E., Keppeler, D., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05110183

NCT05110183 | Opto-electrical Cochlear Implants Neural stimulation with photons has been proposed for a next generation of cochlear implants (CIs). The potential benefit of photonic over electrical ...

2. withpower.com withpower.com/trial/phase-2022-5b70d

Opto-electrical Stimulation for Hearing Loss (oCI Trial) Among the EAS candidates, only 5.83% (2 individuals) actually received the EAS implant surgery, highlighting the need for healthcare professionals to thoroughly ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12551331/

The auditory nerve implant—concept and device description ... Animal studies demonstrate that the ANI achieves substantially lower thresholds and more selective neural activation compared to CI stimulation, ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7136966/

Towards the optical cochlear implant: optogenetic approaches ... Cochlear optogenetics promises increased spectral selectivity of artificial sound encoding, hence improved hearing, as light can conveniently be ...

5. pnas.org pnas.org/doi/10.1073/pnas.2507582122

Toward elucidating the mechanism of cochlear stimulation ... In severe to profound hearing loss, eCIs bypass the damaged or lost sensory hair cells to directly stimulate spiral ganglion neurons (SGNs).

6. clinicaltrial.be clinicaltrial.be/en/details/176145?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

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