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

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

Study Overview

• Status: Completed
• Conditions: Cochlear Implant; Sensorineural Hearing Loss, Bilateral
• Intervention / Treatment: Device: Commercially available cochlear implant and AI system

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Englewood, Colorado, United States, 80113
      • Rocky Mountain Ear Center
  • Maryland
    • Baltimore, Maryland, United States, 21204
      • Greater Baltimore Medical Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48108
      • University of Michigan
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Midwest Ear Institute
  • New York
    • New York, New York, United States, 10016
      • New York University
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73120
      • Hearts for Hearing
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
  • Texas
    • Houston, Texas, United States, 77074
      • Cochlear Hearing Center Houston
  • Utah
    • Provo, Utah, United States, 84604
      • Peak ENT Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Newly Implanted CI Recipients; 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: Existing CI recipients; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Monosyllabic Word Recognition Scores (CNC) in Quiet	Monosyllabic word recognition was scored in quiet using Consonant-Nucleus-Consonant (CNC) words. Scores are listed as percentage correct thus a higher score (percentage) means a better outcome.Group 1: Preoperative to postoperative percentage performance after 6 months of cochlear implant use. Group 2: Visit A to Visit B after 1 month of cochlear implant use.	Pre-operative/Visit A; Group 1: 6 months; Group 2: 1 month

Collaborators and Investigators

• Sponsor: Cochlear

Publications and helpful links

General Publications

• Zwolan TA, Presley R, Chenier L, Buck B. Investigation of an Outcomes-Driven, Computer-Assisted Approach to CI Fitting in Newly Implanted Patients. Ear Hear. 2021 May/Jun;42(3):558-564. doi: 10.1097/AUD.0000000000000957.

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2017
• Primary Completion (Actual): September 18, 2019
• Study Completion (Actual): September 18, 2019

Study Registration Dates

• First Submitted: October 3, 2017
• First Submitted That Met QC Criteria: October 3, 2017
• First Posted (Actual): October 6, 2017

Study Record Updates

• Last Update Posted (Actual): October 29, 2020
• Last Update Submitted That Met QC Criteria: October 7, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Hearing Loss, Sensorineural; Hearing Loss, Bilateral
• Other Study ID Numbers: CAM 5417

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No