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

Cochlear Implant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03304106
• Other study ID #: CAM 5417
• Status: Completed
• Phase: N/A
• Start date: October 19, 2017
• Est. completion date: September 18, 2019

Study information

• Verified date: October 2020
• Source: Cochlear
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: September 18, 2019
• Est. primary completion date: September 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cochlear Implant
• Hearing Loss
• Hearing Loss, Bilateral
• Hearing Loss, Sensorineural
• Sensorineural Hearing Loss, Bilateral

Intervention

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

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Greater Baltimore Medical Center	Baltimore	Maryland
United States	Rocky Mountain Ear Center	Englewood	Colorado
United States	Cochlear Hearing Center Houston	Houston	Texas
United States	Midwest Ear Institute	Kansas City	Missouri
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	New York University	New York	New York
United States	Hearts for Hearing	Oklahoma City	Oklahoma
United States	Peak ENT Associates	Provo	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Cochlear

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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