Hearing Disorder Studies

If you think you may qualify for one of these studies, please contact CNI’s Research Department at 303-806-7423.

CI532: Clinical Evaluation of the Cochlear Nucleus CI532 Cochlear Implant in Adults (SME)

The purpose of this study is to gather long-term outcome data on the FDA approved CI532 cochlear implant, and CI1000 (Nucleus 7) sound processor. Appropriate subjects are implanted with a CI532 cochlear implant and fit with the CP1000 sound processor.  Imaging is completed pre-op, intra-op, and post-op to assess implant location.  Speech perception testing as well as subjective questionnaires are administered over 12 months.

eligibility and information – Open to enrollment
Principal Investigator: David C. Kelsall, MD
Research Coordinator: Judith Stucky (303.806.7416)


CMS: Evaluation of Revised Indicatons (ERID) for Cochlear Implant Candidacy for the Adult CMS Population

The purpose of this study is to evaluate the benefits of cochlear implantation in CMS (Medicare) eligible adult patients who obtain a score that falls in the 41-60% correct range on a sentence recognition test referred to as AZBio sentences and who demonstrate moderate low frequency thresholds up to and including 1000 Hz, and a severe to profound sensorineural high frequency (above 3000 Hz) hearing loss.

eligibility and information – Open to enrollment
Principal Investigator: David C. Kelsall, MD
Research Coordinator: Judith Stucky (303.806.7416)


FAST: Investigation of the FAST Sound Coding Strategy in Newly Implanted Adult Cochlear Implant Recipients

The purpose of this study is to evaluate an investigational sound coding strategy called FAST. “Sound coding strategy” refers to the way that the cochlear implant stimulates the ear. The most commonly used strategy among Nucleus® cochlear implant recipients is called ACE. The main objective is to compare patients’ speech understanding ability while using FAST and ACE.

Open to enrollment
Principal Investigator: David C. Kelsall, MD
Research Coordinator: Judith Stucky (303.806.7416)


FOX: Clinical Investigation of New CI Delivery Models in an Adult Nucleus CI Population

The objective of this research is to compare speech recognition performance at 60 dBA across various study intervals.

Open to enrollment
Principal Investigator: David C. Kelsall, MD
Research Coordinator: Judith Stucky (303.806.7416)


HNE: Hybrid L24 New Enrollment Post Approval Study

The purpose of the Nucleus Hybrid L24 Implant System New Enrollment study is to gather long-term safety and effectiveness data on the device in a larger population than that reported in the pivotal research trial. This real-world experience may provide education about sub-groups of patients, evaluate training programs, and further explore the type and frequency of adverse events beyond that which could be captured during the original clinical trial.

eligibility and information – Open to enrollment
Principal Investigator: David C. Kelsall, MD
Research Coordinator: Judith Stucky (303.806.7416)


Perc: Nucleus Percutaneous Contour Advance Clinical Study

Cochlear implants have been studied since the early 1970s.  Continual improvements in sound quality, speech performance in noise and music appreciation remain the focus of cochlear implant researchers today.  In order to determine what features and capabilities may be useful for future cochlear implants, CNI is coordinating research activities at Rocky Mountain Ear Center, PC, as a site for a study of subjects temporarily implanted with an experimental device.  Candidates for this experimental device do not require health insurance coverage.  If an individual qualifies for participation in the study and agrees to the study’s requirements, the study sponsor will provide the experimental device and the commercial cochlear implant, a speech processor and the accessories to use during and after the study, and standard care (surgical procedures, initial programming of the device and postoperative programming) free of charge.  The testing will take place over a minimum of 36 days spread across 18 months of participation.  During the 36 days of testing, participants will complete listening tasks and speech understanding tests that will assess the recipient’s ability to discriminate, identify and quantify different parts of a sound stimulus.  Approximately 18 months after implantation, the experimental implant is removed and replaced with the latest commercially available Nucleus implant technology.

eligibility and information – Open to enrollment
Principal Investigator: David C. Kelsall, MD
Research Coordinator: Judith Stucky (303.806.7416)
 

 

 

Colorado Neurological Insitute