Investigating Auditory Processing in the Users of Auditory Brainstem and Cochlear Implants

Study Overview
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Brief Summary
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This is a basic investigational research study conducted with hearing impaired adults and children who use cochlear implant or auditory brainstem implant (ABI) devices. The study will evaluate different aspects of hearing and auditory processing in the users of implantable auditory devices.

Official Title
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Investigating Auditory Processing in the Users of Auditory Brainstem and Cochlear Implants

Conditions
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Deafness

Intervention / Treatment
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* Device: Electrode-Neural Interface


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hearing impaired adult and or child (above 2 years old) who uses ABIs or cochlear implants. No diagnosis of any other communicative or cognitive disorder other than hearing impairment. The individual must be able to visit the lab in order to participate in behavioral and electrophysiological experiments. Patients' implant device must have useable electrodes that do not result in uncomfortable or unpleasant non-auditory sensation. Exclusion Criteria: Diagnosed cognitive or communicative disorders (other than hearing impairment) Severe neurological disorders No useable electrodes in their implants

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hearing-Impaired Individuals who use Cochlear Implants or Auditory Brainstem Implant (ABI) Devices<br>Two types of measurements will be obtained: Perceptual: one or more sounds are presented and a behavioral response is collected (e.g., judgements of loudness, pitch or other differences between the sounds, or identifying the word or sentence that was said). Physiological: noninvasive electrophysiological recordings of nervous system activity. | Device: Electrode-Neural Interface<br>* Measurements taken from the electrode-neural interface will be used to guide elimination of poorly functioning ABI electrodes and improve speech perception outcomes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Correctly-Identified Speech Materials | Participants will listen to speech sounds and indicate what sentence or word they heard. The outcome is the percent of speech sounds that are correctly identified. | Day 1 (Visit 1 - Average visit length is about 3 hours) | 
| Percent of Correctly-Identified Stimuli Characteristics when Two or More Stimuli are Presented | Two or more stimuli will be presented to participants, who will indicate which one is louder, which is higher pitched, or which one is different. The outcome is the percent of stimuli characteristics that are correctly identified. | Day 1 (Visit 1 - Average visit length is about 3 hours) |