Evaluation of the Nucleus Hybrid™ L24 Cochlear Implant System

June 19, 2015 updated by: Cochlear

Evaluation of the Nucleus Hybrid™ L24 Cochlear Implant

The purpose of this study is to evaluate the safety and efficacy associated with the provision of acoustic and electric sound processing to individuals who demonstrate significant residual low-frequency hearing and profound high-frequency (above 1500 Hz) sensorineural hearing loss. Delivery of acoustic-electric stimulation will be provided by the Nucleus Hybrid L24 cochlear implant system.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • NYU Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Eighteen years of age or older at the time of implantation.
  2. Severe to profound (a threshold average of 2000, 3000, & 4000 Hz > 75dB HL) sensorineural hearing loss for frequencies > 1500 Hz. Low-frequency thresholds up to and including 500 Hz should be no poorer than 60 dB HL.
  3. Consonant Nucleus Consonant (CNC) monosyllabic word recognition score (mean of two lists) between 10% and 60%, inclusive (i.e., 10% <= score <= 60%), in the ear to be implanted.
  4. CNC word recognition score in the contralateral ear equal to, or better than, the ear to be implanted but not more than 80%.
  5. English spoken as a primary language.

Exclusion Criteria:

  1. Duration of severe-to-profound hearing loss greater than 30 years.
  2. Congenital hearing loss (for the purpose of this study, onset prior to 2 years-of-age).
  3. Medical or psychological conditions that contraindicate undergoing surgery.
  4. Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array.
  5. Conductive overlay of 15 dB or greater at two or more frequencies, in the range 250 to 1000 Hz.
  6. Hearing loss of neural or central origin.
  7. Diagnosis of Auditory Neuropathy.
  8. Active middle-ear infection.
  9. Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure(s) and prosthetic devices.
  10. Unwillingness or inability of the candidate to comply with all investigational requirements.
  11. Additional handicaps that would prevent or restrict participation in the audiological evaluations.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Surgery
Implantation with the Nucleus Hybrid L24 Cochlear Implant
Device: Nucleus Hybrid L24
Implantation with Nucleus Hybrid L24 cochlear implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Consonant Nucleus Consonant (CNC) Monosyllabic Word Score-Treated Ear (CO-PRIMARY)
Time Frame: 6 Months Postactivation

The co-primary study endpoints will be statistically significant differences between the mean, preoperative monosyllabic CNC word score (unilateral acoustic, ear to be implanted) and the postoperative monosyllabic CNC word scores (Hybrid mode) for the activated, Hybrid L24 cochlear implant subjects.

The CNC Words test consists of 10 recorded lists of 50 monosyllabic words in CD format. For this study, two lists will be administered in quiet at a level equal to 60 dBA in the sound field and scored as a total number of words correct, which will be expressed as a percentage correct for this study.
6 Months Postactivation
AzBio Sentence Score in Noise - Treated Ear (Co-Primary)
Time Frame: 6 Months Postactivation

The co-primary study endpoints will be statistically significant differences between the mean, preoperative AzBio Sentences score in noise (unilateral acoustic, ear to be implanted) and postoperative AzBio Sentences score in noise (Hybrid mode) for the activated, Hybrid L24 cochlear implant subjects.

The AzBio Sentence Test consists of 15 lists of 20 sentences each. AzBio sentences are spoken by different talkers in a conversational style with limited contextual cues that the listener can use to predict or 'fill in' unintelligible words. Each list includes 5 sentences from 4 different male and female speakers. Each word in the sentence counts towards the overall score.
6 Months Postactivation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Consonant Nucleus Consonant (CNC) Monosyllabic Words - Treated Ear
Time Frame: 6 Months Postactivation

Secondary efficacy endpoints using binomial comparisons (based on the postoperative Hybrid condition) are as follows:

The CNC Words test consists of 10 recorded lists of 50 monosyllabic words in CD format. For this study, two lists will be administered in quiet at a level equal to 60 dBA in the sound field. The percentage of subjects that scored equal to or better than they did in the pre-operative unilateral acoustic-only condition will be reported.
6 Months Postactivation
AzBio Sentence Score-Treated Ear
Time Frame: 6 Months Postactivation

Secondary efficacy endpoints using binomial comparisons (based on the postoperative Hybrid condition) are as follows:

The AzBio Sentence Test consists of 15 lists of 20 sentences each. AzBio sentences are spoken by different talkers in a conversational style with limited contextual cues that the listener can use to predict or 'fill in'unintelligible words. Each list includes 5 sentences from 4 different male and female speakers. Each word in the sentence counts toward the overall score. The percentage of subjects that scored equal to or better than they did in the pre-operative acoustic only condition will be reported.
6 Months Postactivation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cochlear

Investigators

  • Principal Investigator: John T Roland, MD, NYU Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

May 14, 2008

First Submitted That Met QC Criteria

May 14, 2008

First Posted (Estimate)

May 16, 2008

Study Record Updates

Last Update Posted (Estimate)

July 15, 2015

Last Update Submitted That Met QC Criteria

June 19, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CORP5180

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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