Opto-electrical Cochlear Implants

Summary

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.

Conditions

• Hearing Loss

Interventions

DEVICE

electrical stimulation

A cochlear implant electrode will be inserted through a cochleostomy into scala tympani of the cochlear basal turn. Custom software on a laptop computer will be used to control the delivery of a sequence of charge balanced current pules.

OTHER

optical stimulation

Optical fibers will be inserted through a cochleostomy into scala tympani of the cochlear basal turn. Custom software will be used to control the delivery of a sequence of charge balanced current pules.

OTHER

combined optical and electrical stimulation

A short hybrid array consisting of optical sources and electrical contacts will be inserted through a cochleostomy into scala tympani of the cochlear basal turn. Biphasic electrical current pulse and optical pulse delivery will be controlled in amplitude and timing by a computer.

Sponsors & Collaborators

• University of Miami

  collaborator OTHER

• University of Missouri-Columbia

  collaborator OTHER

• National Institute on Deafness and Other Communication Disorders (NIDCD)

  collaborator NIH

• Northwestern University

  lead OTHER

Principal Investigators

• Claus-Peter Richter, MD, PhD · Northwestern University

Study Design

Allocation

NA

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

89 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-04-20

Primary Completion

2027-12-01

Completion

2027-12-31

FDA Device

Yes

Countries

• United States

Study Locations