Recruiting
Phase 1

Cochlear Implant

Sponsor:

Philip Loizou

Code:

NCT01620385

Conditions

Hearing Impaired

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

ciPDA

Study Details

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.

Conditions

Hearing Impaired

Study ID

NCT01620385

Start date

Jun, 2011

Status verified date

Jun, 2012

Completion date

Jun, 2013

Anticipated

Primary completion date

Jun, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: ciPDA

Interventions

ciPDA

The ciPDA Research Platform device was designed as a research tool for cochlear implant research.

Primary outcome 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. [ Time Frame: 5 weeks ]

Central Contacts and Locations

Central contacts

Philip Loizou, PhD

972-883-4617loizou@utdallas.edu

Locations

University of Texas - Dallas

Recruiting

Richardson, Texas, United States, 75083

More Information

Sponsor

Philip Loizou

Last update posted

Jun 15, 2012

Last verified

Jun, 2012

Keywords

  • Cochlear implants

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Philip Loizou on 2012-06-15.