Cochlear Implant PDA Based Research Platform
Status unconfirmed · Phase 1
Conditions studied: Hearing Impaired
In brief
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.
Key facts
- Study ID
- NCT01620385
- Run by
- Philip Loizou
- People needed
- 60
- Starts
- 2011-06-01
- Expected to finish
- 2013-06-01
- Last updated by the study team
- 2012-06-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
- 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
You may not qualify if…
- 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
Where it is running
- University of Texas - Dallas — Richardson, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
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