Cochlear Implant PDA Based Research Platform (ciPDA)

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.

Study Overview

• Status: Unknown
• Conditions: Hearing Impaired
• Intervention / Treatment: Device: ciPDA

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Philip Loizou, PhD; Phone Number: 972-883-4617; Email: loizou@utdallas.edu

Study Locations

• United States
  • Texas
    • Richardson, Texas, United States, 75083
      • Recruiting
      • University of Texas - Dallas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ciPDA	Device: ciPDA; The ciPDA Research Platform device was designed as a research tool for cochlear implant research.; Other Names: Single arm study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Philip Loizou
• Investigators: Principal Investigator: Philip Loizou, PhD, The University of Texas at Dallas

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Anticipated): June 1, 2013
• Study Completion (Anticipated): June 1, 2013

Study Registration Dates

• First Submitted: September 8, 2011
• First Submitted That Met QC Criteria: June 12, 2012
• First Posted (Estimate): June 15, 2012

Study Record Updates

• Last Update Posted (Estimate): June 15, 2012
• Last Update Submitted That Met QC Criteria: June 12, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: Cochlear implants
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Deafness
• Other Study ID Numbers: ciPDA0001