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

Primary Purpose

Hearing Loss, Sensorineural

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CI532
Nucleus 7
Sponsored by
Cochlear
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hearing Loss, Sensorineural focused on measuring cochlear implant, sound processor

Eligibility Criteria

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

Inclusion Criteria:

  1. Adults 18 years or older who have a bilateral postlinguistic sensorineural hearing loss.
  2. 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.
  3. Bilateral moderate sloping to profound hearing loss
  4. Minimum of 30 days experience with appropriately fit bilateral amplification, fit using the standardized National Acoustics Laboratory (NAL) fitting method
  5. Proficient in English
  6. Ability to complete testing -

Exclusion Criteria:

  1. Previous cochlear implantation
  2. Pre-linguistically deafened (onset of hearing loss at less than two years of age)
  3. Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array
  4. Duration of severe to profound hearing loss greater than 20 years
  5. Diagnosis of retro-cochlear pathology
  6. Diagnosis of auditory neuropathy
  7. 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
  8. Unwillingness or inability to comply with all investigational requirements
  9. Additional cognitive, medical or social handicaps that would prevent completion of all study requirements-

Sites / Locations

  • Rocky Mountain Ear Center
  • University of Iowa
  • University of Michigan
  • The Center for Hearing and Balance Disorders
  • Midwest Ear Institute
  • Washington University
  • New York University
  • The Ohio State University
  • Hearts for Hearing
  • Dallas Ear Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CI532/N7 study group

Arm Description

All subjects will receive a CI532 cochlear implant (intervention) and be fit with the CP1000 sound processor

Outcomes

Primary Outcome Measures

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

Evaluation of Change in Pre and Post Implantation Speech Recognition in Noise Scores in the Implanted Ear Alone
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.
Change in Pre and Post Implantation Score on the Health Utility Index-3 (HUI3)
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).

Full Information

First Posted
December 27, 2016
Last Updated
December 4, 2020
Sponsor
Cochlear
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1. Study Identification

Unique Protocol Identification Number
NCT03007472
Brief Title
Clinical Evaluation of the Cochlear Nucleus CI532 Cochlear Implant in Adults
Acronym
SME
Official Title
Clinical Evaluation of the Cochlear Nucleus(R) CI532 Cochlear Implant in Adults
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
February 15, 2017 (Actual)
Primary Completion Date
December 3, 2018 (Actual)
Study Completion Date
March 6, 2020 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Sensorineural
Keywords
cochlear implant, sound processor

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
CI532/N7 study group
Arm Type
Experimental
Arm Description
All subjects will receive a CI532 cochlear implant (intervention) and be fit with the CP1000 sound processor
Intervention Type
Device
Intervention Name(s)
CI532
Other Intervention Name(s)
Slim Modiolar Electrode, 532
Intervention Description
Cochlear implant
Intervention Type
Device
Intervention Name(s)
Nucleus 7
Other Intervention Name(s)
N7, CP1000
Intervention Description
Sound processor
Primary Outcome Measure Information:
Title
Change From Pre- to 6 Months Post-implantation Speech Recognition in Quiet in the Implanted Ear Alone
Description
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.
Time Frame
Preoperatively and 6 months post sound processor activation
Secondary Outcome Measure Information:
Title
Evaluation of Change in Pre and Post Implantation Speech Recognition in Noise Scores in the Implanted Ear Alone
Description
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.
Time Frame
Preoperatively and 6 months post sound processor activation
Title
Change in Pre and Post Implantation Score on the Health Utility Index-3 (HUI3)
Description
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).
Time Frame
Preoperatively and 6 months post sound processor activaton
Other Pre-specified Outcome Measures:
Title
Frequency Specific Thresholds and Speech Recognition in Noise or Quiet
Description
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.
Time Frame
12 months post-activation
Title
Speech Perception in Quiet and Noise With Change in Cochlear Implant Programming
Description
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.
Time Frame
Following 12-month study visit but prior to 36-month interval.

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jillian Crosson, PhD
Organizational Affiliation
Senior Manager of Clinical Services
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Megan Mears, AuD
Organizational Affiliation
Clinical Project Manager
Official's Role
Study Director
Facility Information:
Facility Name
Rocky Mountain Ear Center
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48108
Country
United States
Facility Name
The Center for Hearing and Balance Disorders
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Midwest Ear Institute
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
New York University
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
13212
Country
United States
Facility Name
Hearts for Hearing
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
Dallas Ear Institute
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17647093
Citation
Grutters JP, Joore MA, van der Horst F, Verschuure H, Dreschler WA, Anteunis LJ. Choosing between measures: comparison of EQ-5D, HUI2 and HUI3 in persons with hearing complaints. Qual Life Res. 2007 Oct;16(8):1439-49. doi: 10.1007/s11136-007-9237-x. Epub 2007 Jul 24.
Results Reference
background
PubMed Identifier
17178943
Citation
Hiller W, Goebel G. Factors influencing tinnitus loudness and annoyance. Arch Otolaryngol Head Neck Surg. 2006 Dec;132(12):1323-30. doi: 10.1001/archotol.132.12.1323.
Results Reference
background
Citation
Meinert,C(1986).ClinicalTrials:Design,Conduct,andAnalysis.OxfordUniversityPress,NewYork.
Results Reference
background
PubMed Identifier
15817019
Citation
Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x. Erratum In: J Am Geriatr Soc. 2019 Sep;67(9):1991.
Results Reference
background
PubMed Identifier
14485785
Citation
PETERSON GE, LEHISTE I. Revised CNC lists for auditory tests. J Speech Hear Disord. 1962 Feb;27:62-70. doi: 10.1044/jshd.2701.62. No abstract available.
Results Reference
background
PubMed Identifier
21829134
Citation
Spahr AJ, Dorman MF, Litvak LM, Van Wie S, Gifford RH, Loizou PC, Loiselle LM, Oakes T, Cook S. Development and validation of the AzBio sentence lists. Ear Hear. 2012 Jan-Feb;33(1):112-7. doi: 10.1097/AUD.0b013e31822c2549.
Results Reference
background
PubMed Identifier
33161258
Citation
Kelsall D, Lupo J, Biever A. Longitudinal outcomes of cochlear implantation and bimodal hearing in a large group of adults: A multicenter clinical study. Am J Otolaryngol. 2021 Jan-Feb;42(1):102773. doi: 10.1016/j.amjoto.2020.102773. Epub 2020 Oct 22.
Results Reference
derived
PubMed Identifier
32857114
Citation
Wick CC, Kallogjeri D, McJunkin JL, Durakovic N, Holden LK, Herzog JA, Firszt JB, Buchman CA; CI532 Study Group. Hearing and Quality-of-Life Outcomes After Cochlear Implantation in Adult Hearing Aid Users 65 Years or Older: A Secondary Analysis of a Nonrandomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2020 Oct 1;146(10):925-932. doi: 10.1001/jamaoto.2020.1585.
Results Reference
derived
PubMed Identifier
32857113
Citation
Buchman CA, Herzog JA, McJunkin JL, Wick CC, Durakovic N, Firszt JB, Kallogjeri D; CI532 Study Group. Assessment of Speech Understanding After Cochlear Implantation in Adult Hearing Aid Users: A Nonrandomized Controlled Trial. JAMA Otolaryngol Head Neck Surg. 2020 Oct 1;146(10):916-924. doi: 10.1001/jamaoto.2020.1584.
Results Reference
derived

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Clinical Evaluation of the Cochlear Nucleus CI532 Cochlear Implant in Adults

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