Implantation With the Nucleus CI532 Cochlear Implant in Adults

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.

Study Overview

• Status: Terminated
• Conditions: Hearing Loss
• Intervention / Treatment: Device: CI532 cochlear implant

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Surgical; Subjects to be implanted with the CI532 cochlear implant in one ear	Device: CI532 cochlear implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months post-activation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months post-activation
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).	6 months post-activation

Collaborators and Investigators

• Sponsor: Cochlear
• Collaborators: NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2016
• Primary Completion (Actual): August 23, 2017
• Study Completion (Actual): August 23, 2017

Study Registration Dates

• First Submitted: February 3, 2016
• First Submitted That Met QC Criteria: February 4, 2016
• First Posted (Estimate): February 9, 2016

Study Record Updates

• Last Update Posted (Actual): March 12, 2019
• Last Update Submitted That Met QC Criteria: February 18, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss
• Other Study ID Numbers: CAM5631

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No