Clinical Evaluation of the Cochlear Nucleus CI532 Cochlear Implant in Adults

Not Applicable

Completed

• Conditions: Hearing Loss, Sensorineural
• Interventions: Device: CI532; Device: Nucleus 7

• Registration Number: NCT03007472
• Lead Sponsor: Cochlear

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.

Study Timeline

• Study First Submitted: 2016-12-27
• Study First Submitted QC: 2016-12-30
• Study First Posted: 2017-01-02
• Study Start: 2017-02-15
• Primary Completion: 2018-12-03
• Study Completion: 2020-03-06
• Results First Submitted: 2020-11-09
• Results First Submitted QC: 2020-11-09
• Status Verified: 2020-12
• Results First Posted: 2020-12-03
• Last Update Submitted: 2020-12-04
• Last Update Posted: 2020-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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-

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CI532/N7 study group	Nucleus 7	All subjects will receive a CI532 cochlear implant (intervention) and be fit with the CP1000 sound processor
CI532/N7 study group	CI532	All subjects will receive a CI532 cochlear implant (intervention) and be fit with the CP1000 sound processor

Primary Outcome Measures

Name	Time	Method
Change From Pre- to 6 Months Post-implantation Speech Recognition in Quiet in the Implanted Ear Alone	Preoperatively and 6 months post sound processor activation	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

Name	Time	Method
Change in Pre and Post Implantation Score on the Health Utility Index-3 (HUI3)	Preoperatively and 6 months post sound processor activaton	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).
Evaluation of Change in Pre and Post Implantation Speech Recognition in Noise Scores in the Implanted Ear Alone	Preoperatively and 6 months post sound processor activation	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.

Trial Locations

Locations (10)

The Ohio State University; 🇺🇸 Columbus, Ohio, United States

University of Iowa; 🇺🇸 Iowa City, Iowa, United States

Midwest Ear Institute; 🇺🇸 Kansas City, Missouri, United States

Washington University; 🇺🇸 Saint Louis, Missouri, United States

The Center for Hearing and Balance Disorders; 🇺🇸 Chesterfield, Missouri, United States

New York University; 🇺🇸 New York, New York, United States

Hearts for Hearing; 🇺🇸 Oklahoma City, Oklahoma, United States

Rocky Mountain Ear Center; 🇺🇸 Englewood, Colorado, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Dallas Ear Institute; 🇺🇸 Dallas, Texas, United States