Clinical Evaluation of the Nucleus 5 Cochlear Implant (CI) System

Hearing Loss Clinical Trial

Official title:

Clinical Evaluation of the Nucleus 5 Cochlear Implant System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01072409
• Other study ID #: CAM5255
• Status: Completed
• Phase: N/A
• First received: February 18, 2010
• Last updated: September 18, 2014
• Start date: March 2010
• Est. completion date: November 2012

Study information

• Verified date: September 2014
• Source: Cochlear
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

To evaluate the performance of the Nucleus 5 Cochlear Implant System.

Description:

Performance outcomes of newly implanted adult recipients using the Nucleus 5 Cochlear Implant System.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Eighteen years of age or older at the time of the study.

• Postlinguistic onset of bilateral severe-to-profound sensorineural hearing loss

• Bilateral severe-to-profound hearing loss that meets current cochlear implant criteria (<50% open-set sentence recognition in quiet scores in the ear to be implanted and <60% in the best-aided condition)

• English spoken as the primary language.

• Willingness to participate in and to comply with all requirements of the study

• Subject may receive bilateral simultaneous cochlear implants.

Exclusion Criteria:

• Previous cochlear implant experience

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

• Ossification, absence of cochlear development or any other cochlear anomaly that might prevent complete insertion of the electrode array.

• Normal hearing in one or both ears.

• Hearing loss of neural or central origin (e.g., deafness due to lesions on the acoustic nerve or central auditory pathway).

• Active middle-ear infection.

• Unwillingness and/or inability of the candidate to comply with all investigational requirements including, but not limited to, study protocol and surgical procedure.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hearing Loss

Intervention

Device:
• Nucleus 5 Cochlear implant
Cochlear implant surgery
• Cochlear implantation
Implantation

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Cochlear

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CNC Monosyllabic Word Performance - Treated Ear	CNC Word Test is a validated test of open-set word recognition. The test consists of 10 lists with 50 monosyllabic words in each list. Subject responses are scored for both words and phonemes correct in the correct sequence. Subjects will be tested using a configuration of speech at 0º azimuth in quiet.	12 months	No