Evaluation of the Nucleus Hybrid™ L24 Cochlear Implant System

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Cochlear
ClinicalTrials.gov Identifier:
NCT00678899
First received: May 14, 2008
Last updated: September 26, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention
Sensorineural Hearing Loss
Device: Nucleus Hybrid L24

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the Nucleus Hybrid™ L24 Cochlear Implant

Resource links provided by NLM:


Further study details as provided by Cochlear:

Primary Outcome Measures:
  • Consonant Nucleus Consonant (CNC) Monosyllabic Word Score-Treated Ear (CO-PRIMARY) [ Time Frame: 6 Months Postactivation ] [ Designated as safety issue: No ]

    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.


  • AzBio Sentence Score in Noise - Treated Ear (Co-Primary) [ Time Frame: 6 Months Postactivation ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Consonant Nucleus Consonant (CNC) Monosyllabic Words - Treated Ear [ Time Frame: 6 Months Postactivation ] [ Designated as safety issue: No ]

    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. On the CNC word measure, most (> 75%) of the subjects will score equal to or better than they did in the preoperative unilateral acoustic-only condition. The percentage of subjects that scored equal to or better than they did in the pre-operative unilateral acoustic-only condition will be reported.


  • AzBio Sentence Score-Treated Ear [ Time Frame: 6 Months Postactivation ] [ Designated as safety issue: No ]

    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. On the AzBio Sentence score in noise, most (> 75%) of the subjects will score equal to or better than they did in the preoperative unilateral acoustic-only condition. The percentage of subjects that scored equal to or better than they did in the pre-operative acoustic only condition will be reported.



Enrollment: 50
Study Start Date: April 2008
Estimated Study Completion Date: January 2015
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Surgery
Implantation with the Nucleus Hybrid L24 Cochlear Implant
Device: Nucleus Hybrid L24
Implantation with Nucleus Hybrid L24 cochlear implant

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00678899

Locations
United States, New York
NYU Medical Center
New York, New York, United States, 10016
Sponsors and Collaborators
Cochlear
Investigators
Principal Investigator: John T Roland, MD NYU MEDICAL CENTER
  More Information

No publications provided

Responsible Party: Cochlear
ClinicalTrials.gov Identifier: NCT00678899     History of Changes
Other Study ID Numbers: CORP5180
Study First Received: May 14, 2008
Results First Received: September 10, 2014
Last Updated: September 26, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Cochlear:
High frequency severe to profound

Additional relevant MeSH terms:
Hearing Loss
Deafness
Hearing Loss, Sensorineural
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on October 01, 2014