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

Not Applicable

Completed

• Conditions: Sensorineural Hearing Loss, Bilateral; Cochlear Implant
• Interventions: Device: Commercially available cochlear implant and AI system

• Registration Number: NCT03304106
• Lead Sponsor: Cochlear

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-03
• Study First Submitted QC: 2017-10-03
• Study First Posted: 2017-10-06
• Study Start: 2017-10-19
• Primary Completion: 2019-09-18
• Study Completion: 2019-09-18
• Results First Submitted: 2020-09-09
• Status Verified: 2020-10
• Results First Submitted QC: 2020-10-07
• Last Update Submitted: 2020-10-07
• Results First Posted: 2020-10-29
• Last Update Posted: 2020-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Existing CI recipients	Commercially available cochlear implant and AI system	Use of AI technology to assist in audiologist's evaluation and programming of existing cochlear implant recipients
Newly Implanted CI Recipients	Commercially available cochlear implant and AI system	Use of AI technology to assist in audiologist's evaluation and programming of new (standard of care-commercial) cochlear implant recipients

Primary Outcome Measures

Name	Time	Method
Change in Monosyllabic Word Recognition Scores (CNC) in Quiet	Pre-operative/Visit A; Group 1: 6 months; Group 2: 1 month	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.

Trial Locations

Locations (9)

Rocky Mountain Ear Center; 🇺🇸 Englewood, Colorado, United States

Greater Baltimore Medical Center; 🇺🇸 Baltimore, Maryland, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

Hearts for Hearing; 🇺🇸 Oklahoma City, Oklahoma, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

New York University; 🇺🇸 New York, New York, United States

Midwest Ear Institute; 🇺🇸 Kansas City, Missouri, United States

Cochlear Hearing Center Houston; 🇺🇸 Houston, Texas, United States

Peak ENT Associates; 🇺🇸 Provo, Utah, United States