NCT02677220

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2016

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 9, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

May 11, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 23, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 23, 2017

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

March 12, 2019

Completed
Last Updated

March 12, 2019

Status Verified

February 1, 2019

Enrollment Period

1.3 years

First QC Date

February 3, 2016

Results QC Date

January 30, 2019

Last Update Submit

February 18, 2019

Conditions

Hearing Loss

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Glasgow Benefit Inventory

    6 months post-activation

  • Speech, Spatial, and Qualities of Hearing Scale

    6 months post-activation

Study Arms (1)

Surgical

EXPERIMENTAL

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

Device: CI532 cochlear implant

Interventions

CI532 cochlear implantDEVICE
Surgical

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Meet current cochlear implant criteria at the implanting center
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYU Medical Center

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Director of Clinical Research
Organization
Cochlear
loneill@cochlear.com
3032647180

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2016

First Posted

February 9, 2016

Study Start

May 11, 2016

Primary Completion

August 23, 2017

Study Completion

August 23, 2017

Last Updated

March 12, 2019

Results First Posted

March 12, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)