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

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ClinicalTrials.gov Identifier: NCT03304106
Recruitment Status : Enrolling by invitation
First Posted : October 6, 2017
Last Update Posted : May 3, 2018
Sponsor:
Information provided by (Responsible Party):
Cochlear

Brief Summary:
Use of Artificial Intelligent (AI) technology to assist audiologists in programming cochlear implants.

Condition or disease Intervention/treatment Phase
Sensorineural Hearing Loss, Bilateral Cochlear Implant Device: Commercially available cochlear implant and AI system Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Investigation of New CI Delivery Models in an Adult Nucleus CI Population
Actual Study Start Date : October 19, 2017
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1
Use of AI technology to assist in audiologist's evaluation and programming of new (standard of care-commercial) cochlear implant recipients
Device: Commercially available cochlear implant and AI system
Use of AI technology to assist in audiologist's evaluation and programming of cochlear implant recipients

Experimental: Group 2
Use of AI technology to assist in audiologist's evaluation and programming of existing cochlear implant recipients
Device: Commercially available cochlear implant and AI system
Use of AI technology to assist in audiologist's evaluation and programming of cochlear implant recipients




Primary Outcome Measures :
  1. Change in open set monosyllabic word recognition score [ Time Frame: Group 1: 6 month; Group 2: 1 month ]
    monosyllabic word score



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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Newly implanted and existing recipient Groups (Groups 1 and 2):

  • Age 12 and older
  • Monosyllabic word score administered at 60dBA (2 lists) with an appropriately fit hearing aid in the ear to be implanted who are receiving a cochlear implant as standard of care
  • Group 2: 3 months or greater combined experience with commercially available sound processors
  • Fluent spoken English skills

Exclusion Criteria:

  • Unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations
  • Additional cognitive, medical or social handicaps that would prevent completion of all study requirements as determined by the Investigational team
  • Unwillingness or inability of the subject to comply with all investigational requirements
  • Use of an acoustic component in the implanted ear
  • Less than 18 active electrodes
  • Hybrid L Cochlear Implant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03304106


Locations
United States, Colorado
Rocky Mountain Ear Center
Englewood, Colorado, United States, 80113
United States, Maryland
Greater Baltimore Medical Center
Baltimore, Maryland, United States, 21204
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48108
United States, New York
New York University
New York, New York, United States, 10016
United States, Oklahoma
Hearts for Hearing
Oklahoma City, Oklahoma, United States, 73120
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Texas
Cochlear Hearing Center Houston
Houston, Texas, United States, 77074
Sponsors and Collaborators
Cochlear

Responsible Party: Cochlear
ClinicalTrials.gov Identifier: NCT03304106     History of Changes
Other Study ID Numbers: CAM 5417
First Posted: October 6, 2017    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: May 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Hearing Loss
Hearing Loss, Sensorineural
Hearing Loss, Bilateral
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms