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Completed

NCT Number: NCT02755935

CI532 - Early Experience Study

To evaluate performance outcomes in patients implanted with the Cochlear Nucleus CI532 electrode array.

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Key information

Conditions

Sensorineural Hearing Loss, Bilateral 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 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NorthShore University, Skokie, Illinois, United States

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About this study

To compare speech perception and audiometric outcomes in patients implanted with the Cochlear Nucleus CI532 electrode array at 3 months postactivation with their best preoperative hearing status.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Medical and audiological candidate for a CI532 cochlear implant per commercially approved, age appropriate, FDA indications
  • Post-linguistically deafened
  • Ability to complete age appropriate testing

Exclusion criteria

  • Previous cochlear implantation in the ear to be implanted
  • Pre-linguistically deafened (onset of hearing loss at less than two years of age)
  • Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array
  • Diagnosis of retro-cochlear pathology
  • Diagnosis of auditory neuropathy
  • Unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure and use of the prosthetic device
  • Unwillingness or inability to comply with all investigational requirements
  • Additional cognitive handicaps that would prevent participation on all study requirements

Treatment and study plan

Cochlear Nucleus CI532

Device

cochlear implantation

Primary outcomes

  1. Speech Understanding (% Correct) on AzBio Sentences in Quiet in the Implanted Ear

    Time frame: 3 months postactivation of the sound processor

    Unilateral listening performance at 3 months post activation with the CI532 compared to the best aided unilateral preoperative condition for sentence perception in quiet.

  2. Speech Understanding (% Correct) on AzBio Sentences in Noise in the Implanted Ear

    Time frame: 3 months post-activation

    unilateral listening performance at 3 months post activation with the CI532 compared to the best aided unilateral preoperative condition for sentence perception in noise

Sponsors and collaborators

Lead sponsor

Cochlear

Industry

Registry information

Official study title

Implantation With the Cochlear Nucleus® CI532 Implant - Early Experience Study

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 29, 2016
Registry last updated
Mar 20, 2018

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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