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Implantation With the Nucleus CI532 Cochlear Implant in Adults

Primary Purpose

Hearing Loss

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CI532 cochlear implant
Sponsored by
Cochlear
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hearing Loss

Eligibility Criteria

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

Inclusion Criteria:

  • Meet current cochlear implant criteria at the implanting center
  • 18 years or older with bilateral sensorineural hearing loss
  • Limited benefit from appropriate binaural hearing aids
  • Moderate to profound hearing loss in the low frequencies and profound hearing loss in the mid to high frequencies
  • Preoperative unaided threshold between 40 and 65 dB HL, inclusively, at 250 Hertz (Hz) and 500 Hz in the ear to be implanted
  • Fluent speaker in the language used to assess clinical performance

Exclusion Criteria:

  • Evidence of hearing loss prior to age 5
  • Sensorineural severe to profound hearing loss greater than 20 years at and above 2000Hz
  • Simultaneous bilateral implantation prior to the study
  • Medical or psychological conditions that contraindicate undergoing general anesthesia or surgery
  • Cochlear anomaly that might prevent complete insertion of the electrode array
  • Hearing impairment due to lesion or neuropathy of the acoustic nerve, VIII nerve, or central auditory pathway
  • Active middle ear infection
  • Tympanic membrane perforation
  • Unrealistic expectations
  • Unwillingness or inability co comply with all investigational requirements
  • Patients with existing cerebral shunts or drains
  • Recurrent episodes of bacterial meningitis

Sites / Locations

  • NYU Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Surgical

Arm Description

Subjects to be implanted with the CI532 cochlear implant in one ear

Outcomes

Primary Outcome Measures

AzBio Sentence Recognition in Noise
The AzBio Sentence test was recorded at 3 months prior to subject withdraw. Not collected at endpoint. AzBio Tests 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 and the resulting score is presented in percent correct.

Secondary Outcome Measures

Glasgow Benefit Inventory
The Glasgow Benefit Inventory (GBI) is a health utility assessment used at six months post-operatively. Performance benefits are a change in score from pre- to post-operatively, scored from -100 to +100.
Speech, Spatial, and Qualities of Hearing Scale
The Speech Spatial and Qualities of Hearing Scale (SSQ) is a subjective measure of satisfaction. Change is reflected in a gain in scores pre- to post-operatively (-10 to +10).

Full Information

First Posted
February 3, 2016
Last Updated
February 18, 2019
Sponsor
Cochlear
Collaborators
NYU Langone Health
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1. Study Identification

Unique Protocol Identification Number
NCT02677220
Brief Title
Implantation With the Nucleus CI532 Cochlear Implant in Adults
Official Title
Implantation With the Nucleus CI532 Cochlear Implant in Adults
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Terminated
Why Stopped
No enrolled subjects
Study Start Date
May 11, 2016 (Actual)
Primary Completion Date
August 23, 2017 (Actual)
Study Completion Date
August 23, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cochlear
Collaborators
NYU Langone Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study is to investigate the clinical benefit for patients implanted with the Nucleus® CI532 cochlear implant. The Nucleus® CI532 has a pre-curved, perimodiolar array, the EA32, which is introduced into the cochlea through a straightening sheath.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Surgical
Arm Type
Experimental
Arm Description
Subjects to be implanted with the CI532 cochlear implant in one ear
Intervention Type
Device
Intervention Name(s)
CI532 cochlear implant
Primary Outcome Measure Information:
Title
AzBio Sentence Recognition in Noise
Description
The AzBio Sentence test was recorded at 3 months prior to subject withdraw. Not collected at endpoint. AzBio Tests 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 and the resulting score is presented in percent correct.
Time Frame
3 months post-activation
Secondary Outcome Measure Information:
Title
Glasgow Benefit Inventory
Description
The Glasgow Benefit Inventory (GBI) is a health utility assessment used at six months post-operatively. Performance benefits are a change in score from pre- to post-operatively, scored from -100 to +100.
Time Frame
6 months post-activation
Title
Speech, Spatial, and Qualities of Hearing Scale
Description
The Speech Spatial and Qualities of Hearing Scale (SSQ) is a subjective measure of satisfaction. Change is reflected in a gain in scores pre- to post-operatively (-10 to +10).
Time Frame
6 months post-activation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Meet current cochlear implant criteria at the implanting center 18 years or older with bilateral sensorineural hearing loss Limited benefit from appropriate binaural hearing aids Moderate to profound hearing loss in the low frequencies and profound hearing loss in the mid to high frequencies Preoperative unaided threshold between 40 and 65 dB HL, inclusively, at 250 Hertz (Hz) and 500 Hz in the ear to be implanted Fluent speaker in the language used to assess clinical performance Exclusion Criteria: Evidence of hearing loss prior to age 5 Sensorineural severe to profound hearing loss greater than 20 years at and above 2000Hz Simultaneous bilateral implantation prior to the study Medical or psychological conditions that contraindicate undergoing general anesthesia or surgery Cochlear anomaly that might prevent complete insertion of the electrode array Hearing impairment due to lesion or neuropathy of the acoustic nerve, VIII nerve, or central auditory pathway Active middle ear infection Tympanic membrane perforation Unrealistic expectations Unwillingness or inability co comply with all investigational requirements Patients with existing cerebral shunts or drains Recurrent episodes of bacterial meningitis
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

Plan to Share IPD
No

Learn more about this trial

Implantation With the Nucleus CI532 Cochlear Implant in Adults

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