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| Name | Class |
|---|---|
| Cochlear Americas | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hearing-Impaired Individuals who use Cochlear Implants or Auditory Brainstem Implant (ABI) Devices | Experimental | Two types of measurements will be obtained:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electrode-Neural Interface | Device | Measurements taken from the electrode-neural interface will be used to guide elimination of poorly functioning ABI electrodes and improve speech perception outcomes. |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mahan Azadpour | Contact | 2122637785 | Mahan.Azadpour@nyulangone.org |
| Name | Affiliation | Role |
|---|---|---|
| Mahan Azadpour | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | Recruiting | New York | New York | 10016 | United States |
The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: [Mahan.Azadpour@nyulangone.org]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research
The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to Mahan.Azadpour@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
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| ID | Term |
|---|---|
| D003638 | Deafness |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |