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Completed

NCT Number: NCT03007472

Clinical Evaluation of the Cochlear Nucleus CI532 Cochlear Implant in Adults

The purpose of this study is to gather long-term data on the FDA approved CI532 cochlear implant, and CP1000 (Nucleus 7) sound processor

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rocky Mountain Ear Center, Englewood, Colorado, United States

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About this study

Appropriate candidates will receive a CI532 cochlear implant and be fit with the CP1000 sound processor. Imaging will be completed pre-op, intra-op, and post-op to assess implant location. Speech perception testing as well as subjective questionnaires will be administered over 12 months.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adults 18 years or older who have a bilateral postlinguistic sensorineural hearing loss.
  • Limited benefit from amplification as defined by test scores of 40% correct or less in the ear to be implanted and 50% or less in the contralateral ear on a recorded monosyllabic word test I. Consistent with the Minimum Speech Test Battery (2011), it is required that all subjects be evaluated at 60 dBA presentation level.
  • Bilateral moderate sloping to profound hearing loss
  • Minimum of 30 days experience with appropriately fit bilateral amplification, fit using the standardized National Acoustics Laboratory (NAL) fitting method
  • Proficient in English
  • Ability to complete testing -

Exclusion criteria

  • Previous cochlear implantation
  • 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
  • Duration of severe to profound hearing loss greater than 20 years
  • 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, medical or social handicaps that would prevent completion of all study requirements-

Treatment and study plan

CI532

Device

Cochlear implant

Other names: Slim Modiolar Electrode, 532

Nucleus 7

Device

Sound processor

Other names: N7, CP1000

Primary outcomes

  1. Change From Pre- to 6 Months Post-implantation Speech Recognition in Quiet in the Implanted Ear Alone

    Time frame: Preoperatively and 6 months post sound processor activation

    Group mean Consonant Nucleus Consonant (CNC) word recognition in quiet measured pre-operatively and again at 6 month post sound processor activation compared to the group mean score in the preoperative, best unilateral condition. The CNC word test has a score range of 0-100% with higher values indicating better scores.

Secondary outcomes

  1. Evaluation of Change in Pre and Post Implantation Speech Recognition in Noise Scores in the Implanted Ear Alone

    Time frame: Preoperatively and 6 months post sound processor activation

    Group mean AzBio sentence in noise score in the best unilateral condition compared to the group mean score in the preoperative, unilateral aided condition. The AzBio sentence test has a score range of 0-100% with higher values indicating better scores.

  2. Change in Pre and Post Implantation Score on the Health Utility Index-3 (HUI3)

    Time frame: Preoperatively and 6 months post sound processor activaton

    Group mean HUI3 score post sound processor activation compared to the scores measured preoperatively. The HUI3 consists of eight attributes of general health (vision, hearing, speech, mobility, dexterity, emotion, cognition, and pain) with five or six levels per attribute. For each respondent, health status is described as a vector that combines the levels of each attribute. This information is then converted into a utility score of HRQL on a scale from perfect health (1.0) to death (0).

Other outcomes

  1. Frequency Specific Thresholds and Speech Recognition in Noise or Quiet

    Time frame: 12 months post-activation

    Frequency-specific thresholds at standard audiometric frequencies for each ear, and speech recognition in quiet (CNC words) or noise (AzBio sentences) in best unilateral and/or electric alone.

  2. Speech Perception in Quiet and Noise With Change in Cochlear Implant Programming

    Time frame: Following 12-month study visit but prior to 36-month interval.

    Two optional study visits to evaluate whether a change in cochlear implant programming, specifically an increase in the number of channels will improve subject speech perception in quiet and noise.

Sponsors and collaborators

Lead sponsor

Cochlear

Industry

Registry information

Official study title

Clinical Evaluation of the Cochlear Nucleus(R) CI532 Cochlear Implant in Adults

Acronym: SME

Important dates

Study start
2017
Primary completion
2018
Study completion
2020
First posted
Jan 2, 2017
Registry last updated
Dec 30, 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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