Opto-electrical Cochlear Implants
Enrolling by invitation · Not applicable
Conditions studied: Hearing Loss
In brief
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.
Key facts
- Study ID
- NCT05110183
- Run by
- Northwestern University
- People needed
- 30
- Starts
- 2025-04-20
- Expected to finish
- 2027-12-31
- Last updated by the study team
- 2026-05-06
Who can join
Age: 18 and older, up to 89. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Criterion for inclusion of a patient is the requirement of the translabyrinthine approach for tumor removal. The surgical approach is determined by the tumor size, the tumor location and the remaining hearing of the patient. Criteria for a translabyrinthine approach are:
- the tumor grows in the pontine angle and the facial nerve is at risk for damage during the surgery because the tumor is already large and in close proximity of the facial nerve AND
- the tumor is larger than 2.5 cm AND
- Pure tone hearing thresholds are elevated by at least 50 dB AND
- Speech discrimination scores are 50% or less
You may not qualify if…
- adults unable to consent.
- individuals who are not yet adults (infants, children, teenagers).
- pregnant women.
- prisoners.
- vulnerable populations
Where it is running
- University of Miami — Coral Gables, Florida, United States
- University of Missouri — Columbia, Missouri, United States
Full record on ClinicalTrials.gov
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