Cochlear Implant PDA Based Research Platform

Phase 1

• Conditions: Hearing Impaired
• Interventions: Device: ciPDA

• Registration Number: NCT01620385
• Lead Sponsor: Philip Loizou

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.

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-09-08
• Status Verified: 2012-06
• Study First Submitted QC: 2012-06-12
• Last Update Submitted: 2012-06-12
• Study First Posted: 2012-06-15
• Last Update Posted: 2012-06-15
• Primary Completion: 2013-06
• Study Completion: 2013-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ciPDA	ciPDA	-

Primary Outcome Measures

Name	Time	Method
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.	5 weeks

Trial Locations

Locations (1)

University of Texas - Dallas; 🇺🇸 Richardson, Texas, United States