Cochlear Implant PDA Based Research Platform

NCT01620385 | Unknown Phase 1

• 1 other identifier: ciPDA0001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

Cochlear implants

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

ciPDA

EXPERIMENTAL

Device: ciPDA

Interventions

ciPDA DEVICE

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

Also known as: Single arm study.

ciPDA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Post-lingually deafened adults:
• 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:
• 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

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

Sponsors & Collaborators

• Philip Loizou: lead

Study Sites (1)

University of Texas - Dallas

Richardson, Texas, 75083, United States

RECRUITING

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Philip Loizou, PhD

  The University of Texas at Dallas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philip Loizou, PhD

CONTACT

972-883-4617; loizou@utdallas.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: September 8, 2011
• First Posted: June 15, 2012
• Study Start: June 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: June 15, 2012

Record last verified: 2012-06

Locations

US (1)