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

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Sensorineural hearing loss
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Brief Title

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

Official Title

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

Brief Summary

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

Study Type

Interventional

Primary Outcome

Change in open set monosyllabic word recognition score

Condition

Sensorineural Hearing Loss, Bilateral

Intervention

Commercially available cochlear implant and AI system

Study Arms / Comparison Groups

 Group 1
Description:  Use of AI technology to assist in audiologist's evaluation and programming of new (standard of care-commercial) cochlear implant recipients

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Device

Estimated Enrollment

87

Start Date

October 19, 2017

Completion Date

September 18, 2019

Primary Completion Date

September 18, 2019

Eligibility 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

Gender

All

Ages

12 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT03304106

Organization ID

CAM 5417

Responsible Party

Sponsor

Study Sponsor

Cochlear

Study Sponsor

, ,

Verification Date

November 2019