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Evaluation of the Nucleus Hybrid™ L24 Cochlear Implant System

Primary Purpose

Sensorineural Hearing Loss

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nucleus Hybrid L24
Sponsored by
Cochlear
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sensorineural Hearing Loss focused on measuring High frequency severe to profound

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • NYU Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Surgery

Arm Description

Implantation with the Nucleus Hybrid L24 Cochlear Implant

Outcomes

Primary Outcome Measures

Consonant Nucleus Consonant (CNC) Monosyllabic Word Score-Treated Ear (CO-PRIMARY)
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)
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
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.
AzBio Sentence Score-Treated Ear
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.

Full Information

First Posted
May 14, 2008
Last Updated
June 19, 2015
Sponsor
Cochlear
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1. Study Identification

Unique Protocol Identification Number
NCT00678899
Brief Title
Evaluation of the Nucleus Hybrid™ L24 Cochlear Implant System
Official Title
Evaluation of the Nucleus Hybrid™ L24 Cochlear Implant
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cochlear

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sensorineural Hearing Loss
Keywords
High frequency severe to profound

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Surgery
Arm Type
Experimental
Arm Description
Implantation with the Nucleus Hybrid L24 Cochlear Implant
Intervention Type
Device
Intervention Name(s)
Nucleus Hybrid L24
Intervention Description
Implantation with Nucleus Hybrid L24 cochlear implant
Primary Outcome Measure Information:
Title
Consonant Nucleus Consonant (CNC) Monosyllabic Word Score-Treated Ear (CO-PRIMARY)
Description
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.
Time Frame
6 Months Postactivation
Title
AzBio Sentence Score in Noise - Treated Ear (Co-Primary)
Description
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.
Time Frame
6 Months Postactivation
Secondary Outcome Measure Information:
Title
Consonant Nucleus Consonant (CNC) Monosyllabic Words - Treated Ear
Description
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.
Time Frame
6 Months Postactivation
Title
AzBio Sentence Score-Treated Ear
Description
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.
Time Frame
6 Months Postactivation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Eighteen years of age or older at the time of implantation. 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. 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. CNC word recognition score in the contralateral ear equal to, or better than, the ear to be implanted but not more than 80%. English spoken as a primary language. Exclusion Criteria: Duration of severe-to-profound hearing loss greater than 30 years. Congenital hearing loss (for the purpose of this study, onset prior to 2 years-of-age). Medical or psychological conditions that contraindicate undergoing surgery. Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array. Conductive overlay of 15 dB or greater at two or more frequencies, in the range 250 to 1000 Hz. Hearing loss of neural or central origin. Diagnosis of Auditory Neuropathy. Active middle-ear infection. 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. Unwillingness or inability of the candidate to comply with all investigational requirements. Additional handicaps that would prevent or restrict participation in the audiological evaluations.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John T Roland, MD
Organizational Affiliation
NYU MEDICAL CENTER
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29330858
Citation
Roland JT Jr, Gantz BJ, Waltzman SB, Parkinson AJ. Long-term outcomes of cochlear implantation in patients with high-frequency hearing loss. Laryngoscope. 2018 Aug;128(8):1939-1945. doi: 10.1002/lary.27073. Epub 2018 Jan 13.
Results Reference
derived

Learn more about this trial

Evaluation of the Nucleus Hybrid™ L24 Cochlear Implant System

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