Perceptual Consequences of Cochlear Implant Electrode-neuron Interfaces

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

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-16

Study Completion Date

2027-03-31

Brief Summary

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Despite the success of cochlear implants, devices surgically placed in the inner ears of patients with severe hearing loss, there remains substantial variability in the overall speech perception outcomes for the children and adults who receive them. The main goals of this project are: i) to improve our understanding of how cochlear implants affect the developing auditory system, ii) apply that knowledge to test new methods for programming children and adults, and iii) to study how long it takes listeners to adapt to new cochlear implant programs over the short- and long-term. The results will improve our understanding of how the deafened auditory system develops with cochlear implant stimulation and advance clinical practice to improve hearing outcomes in cochlear implant listeners.

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Detailed Description

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Conditions

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Deafness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Performance Assessed with Experimental Sound Processing Strategy

Patients listening to experimental cochlear implant processing strategy.

Group Type EXPERIMENTAL

Experimental Speech Processing Strategy

Intervention Type OTHER

Patient's will listen with an experimental speech processor, programmed with a dynamic focusing strategy.

Control

Patients listening to their clinical cochlear implant using their "own" processor (their everyday listening situation).

Group Type NO_INTERVENTION

No interventions assigned to this group

Experimental Control

Patients listening to experimental cochlear implant using a processing strategy like thier clinical program, a "clinical like" program.

Group Type SHAM_COMPARATOR

Experimental Speech Processing Strategy

Intervention Type OTHER

Patient's will listen with an experimental speech processor, programmed with a dynamic focusing strategy.

Interventions

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Experimental Speech Processing Strategy

Patient's will listen with an experimental speech processor, programmed with a dynamic focusing strategy.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adult at least 18 years old
* Native speakers of American English
* Wears a cochlear implant manufactured by Advanced Bionics (Clarion Hi-Focus I or newer), Cochlear, or MED-EL

* Children at least 3 months old
* Native speakers of American English
* Wears a cochlear implant manufactured by Advanced Bionics (Clarion Hi-Focus I or newer), Cochlear, or MED-EL

* For both children and adults with a cochlear implant, some study criteria might pertain to a subset of subjects, such as a specific age at which the subjects developed a hearing loss, or was implanted.

* Unable to carry out the study protocol or tasks required in the study

Exclusion for all Normal Hearing Subjects:

* Inability to provide informed consent
* Hearing loss, or significant history of hearing related issues
* Unable to carry out the study protocol or tasks required in the study