Stimulating the Cochlear Apex Without Longer Electrodes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2027-01-01

Brief Summary

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The most common cochlear implant intervention provides an electrode array that stimulates less than half of the length of the cochlea, leaving the regions which represent lower frequencies in the normally functioning ear unstimulated. Providing stimulation over the entire cochlea has the potential to improve speech understanding, sound quality, as well as spectral and temporal representation. Increasing the length of the electrode array to cover a greater portion of the cochlea has many potential issues, including increased damage to the cochlea and probability of incomplete insertions. In this study, a new technique is being investigated that allows stimulation across the entire cochlear extent without increasing the length of the electrode array. The purpose of this study is to evaluate the benefit of the new technique on speech understanding outcomes. Additionally, the study will investigate the new configuration to explore how the auditory system encodes temporal and spectral information.

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Detailed Description

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Conditions

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Deafness With a Cochlear Implant

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Apical ground electrode

Participants in this group will have already received a cochlear implant using the new approach or be receiving a cochlear implant with the new approach.

Group Type EXPERIMENTAL

Modified surgical approach

Intervention Type PROCEDURE

An electrode typically placed under the temporalis muscle will be placed into the cochlear helicotrema instead.

Cochlear Nucleus CI632 cochlear implant

Intervention Type DEVICE

Cochlear implant (CI) system where stimulation from one of the intracochear electrodes is grounded via one of two (or both) extra cochlear electrodes in the device.

Standard location ground electrode

Participants in this group have received a cochlear implant with the typical ground electrode placement.

Group Type ACTIVE_COMPARATOR

Cochlear Nucleus CI632 cochlear implant

Intervention Type DEVICE

Cochlear implant (CI) system where stimulation from one of the intracochear electrodes is grounded via one of two (or both) extra cochlear electrodes in the device.

Interventions

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Modified surgical approach

An electrode typically placed under the temporalis muscle will be placed into the cochlear helicotrema instead.

Intervention Type PROCEDURE

Cochlear Nucleus CI632 cochlear implant

Cochlear implant (CI) system where stimulation from one of the intracochear electrodes is grounded via one of two (or both) extra cochlear electrodes in the device.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Participants in this study must have already been evaluated at the NYU cochlear implant center as being eligible for a cochlear implant.
* They must have decided to receive a cochlear implant manufactured by Cochlear Limited and have been diagnosed with a moderate to profound sensorineural hearing loss in the ear to be implanted.
* Individuals who have already been implanted with a cochlear implant manufactured by Cochlear Limited with or without this new approach may also participate in this study.

Exclusion Criteria

* They are under the age of 18
* They have not been diagnosed with a moderate to profound sensorineural hearing loss in the ear to be implanted
* Have \>15 years of profound deafness
* Have not chosen to receive a cochlear implant manufactured by Cochlear Limited
* Are pregnant or plan to conceive within 6 months of consenting

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No