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OpenTrials
Completed

NCT Number: NCT03304106

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.

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Key information

Conditions

Sensorineural Hearing Loss, Bilateral Cochlear Implant Ear Diseases Hearing Disorders Hearing Loss Hearing Loss, Sensorineural Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rocky Mountain Ear Center, Englewood, Colorado, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Commercially available cochlear implant and AI system

Device

Use of AI technology to assist in audiologist's evaluation and programming of cochlear implant recipients

Primary outcomes

  1. Change in Monosyllabic Word Recognition Scores (CNC) in Quiet

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Cochlear

Industry

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 6, 2017
Registry last updated
Oct 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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