Clinical trial NCT01620385: Cochlear Implant PDA Based Research Platform
Official title: Multi Center Clinical Study to Assess the Safety of the UTD Cochlear Implant PDA (ciPDA) REsearch Platform
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Hearing Impaired
Keywords: Cochlear implants
Lead sponsor: The University of Texas at Dallas
Sponsor class: OTHER
First posted: 2012-06-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: The objective of this study is to assess the safety of the PDA device after long-term use. Safety shall be measured by the adverse events reported in this study and compared to the study results reported in the clinical study for the PMA'd device.
timeFrame: 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Richardson
country: United States
facility: University of Texas - Dallas
state: Texas
Study officials:
affiliation: The University of Texas at Dallas
name: Philip Loizou, PhD
role: PRINCIPAL_INVESTIGATOR
References: