Cochlear Implant PDA Based Research Platform
| Status: | Completed |
|---|---|
| Conditions: | Other Indications |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | June 2011 |
| End Date: | June 2013 |
| Contact: | Philip Loizou, PhD |
| Email: | loizou@utdallas.edu |
| Phone: | 972-883-4617 |
Multi Center Clinical Study to Assess the Safety of the UTD Cochlear Implant PDA (ciPDA) REsearch Platform
The primary purpose of the research is to study how individuals who wear cochlear implants
process sounds in noisy environments and also whether newly designed programs can help
improve the communicative ability of cochlear implant patients in noisy situations.
process sounds in noisy environments and also whether newly designed programs can help
improve the communicative ability of cochlear implant patients in noisy situations.
Cochlear implants have been successful in restoring partial hearing to profoundly deaf
people. Despite their success, most implant patients are not able to communicate in noisy
environments (e.g., in a restaurant). Communicating in noise still remains one of the
biggest challenges in cochlear implants. Little is known about the factors that contribute
to the poor performance of CI users in noise. In this project, we propose a series of
experiments aimed at isolating these factors. We propose new programs that can be tailored
for noisy situations.
people. Despite their success, most implant patients are not able to communicate in noisy
environments (e.g., in a restaurant). Communicating in noise still remains one of the
biggest challenges in cochlear implants. Little is known about the factors that contribute
to the poor performance of CI users in noise. In this project, we propose a series of
experiments aimed at isolating these factors. We propose new programs that can be tailored
for noisy situations.
Inclusion Criteria:
1. Post-lingually deafened adults:
- 18 years of age or older
- Unilateral or bilateral Nucleus implant users (this includes all three
generations of the Nucleus system, i.e., CI22, CI24 and CI24R).
- With or without residual hearing in the contralateral ear. Subjects may use
amplification (hearing aid) in the opposite or same ear as the implant.
- A minimum test score of 30% in tape-recorded open-set sentence recognition
scores (e.g., spondee identification).
- Minimum of 6 months experience with their implant device. This is done to ensure
that all patients are familiar with the hearing sensations perceived by a
cochlear implant.
- Minimum number of active electrodes: 10
- Minimum number of subjects for each test site: 5
2. Prelingually and perilingually deafened adults:
- 18 years of age or older
- Unilateral or bilateral Nucleus implant users.
- With or without residual hearing in the contralateral ear. Subjects may use
amplification (hearing aid) in the opposite or same ear as the implant.
- A minimum test score of 10% in tape-recorded open-set sentence recognition
scores (e.g., spondee identification).
- Minimum of 6 months experience with their implant device. This is done to ensure
that all patients are familiar with the hearing sensations perceived by a
cochlear implant.
- Minimum number of active electrodes: 10
- Minimum number of subjects for each test site: 5
Exclusion Criteria:
- Non-English speaking
- Hearing loss of neural or central origin
- Absence of cochlear or VIII nerve development
- The presence of systemic condition which would preclude use of a cochlear implant
- Active middle ear infection/tympanic membrane perforation
- Significantly abnormal cognitive function, as determined by case history information
and/or clinical observations
- Significant psychiatric disorder, as determined by case history information and/or
clinical observations
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