Safety and Efficacy of the Cochlear Nucleus CI422 Cochlear Implant in Adults

Hearing Loss Clinical Trial

Official title:

Safety and Efficacy of the Cochlear Nucleus CI422 Cochlear Implant in Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01867008
• Other study ID #: CAM-CI422-2012
• Status: Completed
• Phase: N/A
• Start date: August 2013
• Est. completion date: November 2016

Study information

• Verified date: January 2021
• Source: Cochlear
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Eighteen years of age or older at the time of implantation

2. Moderate low frequency thresholds up to and including 1000 Hz, severe to profound high frequency (above 3000 Hz) sensorineural hearing loss

3. 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

4. Aided Consonant Nucleus Consonant (CNC) word recognition score (mean of two lists) between 10% and 50%, inclusive in the ear to be implanted

5. 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%

6. 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

7. English spoken as a primary language

Exclusion Criteria:

1. Duration of severe-to-profound hearing loss greater than 30 years

2. Congenital hearing loss (for the purpose of this study, onset prior to 2 years-of-age)

3. Medical or psychological conditions that contraindicate undergoing surgery as determined by the Investigator

4. Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array

5. Conductive overlay of 15 decibels (dB) or greater at two or more frequencies, in the range 500 to 1000 Hz

6. Deafness due to lesions of the acoustic nerve or central auditory pathway

7. Absence of cochlear development

8. Diagnosis of auditory neuropathy

9. Active middle-ear infection

10. Tympanic membrane perforation in the presence of active middle ear disease

11. 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

12. Unwillingness or inability of the candidate to comply with all investigational requirements as determined by the Investigator

13. Additional handicaps that would prevent or restrict participation in the audiological evaluations as determined by the Investigator

Related Conditions & MeSH terms

• Hearing Loss

Intervention

Device:
• Nucleus CI422 Cochlear Implant with N6 Sound Processor

Locations

Country	Name	City	State
United States	Greater Baltimore Medical Center	Baltimore	Maryland
United States	University of North Carolina	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Cochlear

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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