NCT01867008

Brief Summary

Clinical study to evaluate the safety and efficacy of the Cochlear™ Nucleus® CI422 cochlear implant for new cochlear implant adult recipients with broader requirements to be considered an eligible candidate.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

May 29, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 3, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
4.1 years until next milestone

Results Posted

Study results publicly available

December 1, 2020

Completed
Last Updated

January 25, 2021

Status Verified

January 1, 2021

Enrollment Period

3.3 years

First QC Date

May 29, 2013

Results QC Date

November 5, 2020

Last Update Submit

January 5, 2021

Conditions

Hearing Loss

Outcome Measures

Primary Outcomes (1)

  • Change in Open Set Monosyllabic Word Recognition Score as Measured on a Consonant Nucleus Consonant (CNC) Word Test

    Performance at 6 months postactivation compared to pre-operative word recognition score (percent correct: 0-100%, where a 0% is the lowest score and a 100% is the highest score)

    Preoperative baseline to 6 months postactivation

Study Arms (1)

Nucleus CI422 Cochlear Implant with Nucleus 6 (N6) Sound Processor

EXPERIMENTAL
Device: Nucleus CI422 Cochlear Implant with N6 Sound Processor

Interventions

Nucleus CI422 Cochlear Implant with N6 Sound ProcessorDEVICE
Nucleus CI422 Cochlear Implant with Nucleus 6 (N6) Sound Processor

Eligibility Criteria

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

You may qualify if:

  • Eighteen years of age or older at the time of implantation
  • Moderate low frequency thresholds up to and including 1000 Hz, severe to profound high frequency (above 3000 Hz) sensorineural hearing loss
  • Minimum of 30 days experience with appropriately fit bilateral amplification, fit using the standardized National Acoustics Laboratory (NAL) fitting method described in the Fitting and Use of Hearing Aids section below
  • Aided Consonant Nucleus Consonant (CNC) word recognition score (mean of two lists) between 10% and 50%, inclusive in the ear to be implanted
  • Aided CNC word recognition score (mean of two lists) in the contralateral ear equal to, or better than, the ear to be implanted but not more than 70%
  • Willingness to use bimodal stimulation (i.e., a cochlear implant on one ear and a hearing aid on the contralateral ear) through at least 6-months postactivation
  • English spoken as a primary language

You may not qualify if:

  • Duration of severe-to-profound hearing loss greater than 30 years
  • Congenital hearing loss (for the purpose of this study, onset prior to 2 years-of-age)
  • Medical or psychological conditions that contraindicate undergoing surgery as determined by the Investigator
  • Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array
  • Conductive overlay of 15 decibels (dB) or greater at two or more frequencies, in the range 500 to 1000 Hz
  • Deafness due to lesions of the acoustic nerve or central auditory pathway
  • Absence of cochlear development
  • Diagnosis of auditory neuropathy
  • Active middle-ear infection
  • Tympanic membrane perforation in the presence of active middle ear disease
  • Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure(s) and prosthetic devices as determined by the Investigator
  • Unwillingness or inability of the candidate to comply with all investigational requirements as determined by the Investigator
  • Additional handicaps that would prevent or restrict participation in the audiological evaluations as determined by the Investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Greater Baltimore Medical Center

Baltimore, Maryland, 21204, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27517, 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
Clinical Project Manager
Organization
Cochlear Americas
knix@cochlear.com
303-264-2340

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

May 29, 2013

First Posted

June 3, 2013

Study Start

August 1, 2013

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

January 25, 2021

Results First Posted

December 1, 2020

Record last verified: 2021-01

Locations

US(2)