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

Not Applicable

Completed

• Conditions: Sensorineural Hearing Loss, Bilateral; Cochlear Implant

• 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

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

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

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

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

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

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

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

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