Evaluation of a Revised Indication for Determining Adult Cochlear Implant Candidacy

NCT01337076 | Completed Results

• 1 other identifier: CAM-EXP-A2010-01
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

The Sponsor values the progression of hearing healthcare practice and acknowledges a need for re-evaluation of indications for determining adult cochlear implant candidacy. This need arises from current research, peer reviewed literature, and technological advancement with concomitant performance outcomes. To address this specifically, the Sponsor proposes to evaluate the safety and efficacy of the Cochlear™ Nucleus® implant system with a revised indication.

Conditions

Hearing Loss

Outcome Measures

Primary Outcomes (1)

• CNC Monosyllabic Word Score - Treated Ear

  The primary study endpoint was to test whether a statistically significant difference could be obtained between the mean, preoperative Consonant Nucleus Consonant (CNC) monosyllabic word score in the ear to be implanted compared to the postoperative CNC word score in the cochlear implant alone condition at 6 months postimplant activation for candidates who currently perform outside the approved Nucleus® cochlear implant candidacy requirements. 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.

  Six months

Study Arms (1)

cochlear implant

OTHER

Device: cochlear implant

Interventions

cochlear implant DEVICE

Cochlear implant surgery

Also known as: implantable hearing device

cochlear implant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eighteen years of age or older at the time of the study.
• Preoperative aided CNC word score in quiet of greater than or equal to 10% and less than or equal to ¬¬40% in the ear to be implanted; equal to but no better than 50% in the contralateral ear
• Bilateral moderate to profound hearing loss in the low frequencies (up to 1000 Hz) and profound sensorineural hearing loss in the high speech frequencies (3000 Hz and above)
• 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 the primary language.

You may not qualify if:

• Congenital hearing loss (for the purpose of this study, onset prior to 2 years-of-age).
• Preoperative aided HINT sentence score less than or equal to 50% in the ear to be implanted
• Ossification, absence of cochlear development or any other cochlear anomaly that might prevent complete insertion of the electrode array.
• 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.

Sponsors & Collaborators

• Cochlear: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Hearing Loss

Interventions

Cochlear Implants

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Neural Prostheses; Implantable Neurostimulators; Electrodes, Implanted; Electrodes; Electrical Equipment and Supplies; Equipment and Supplies; Prostheses and Implants; Hearing Aids; Sensory Aids

Results Point of Contact

• Title: Dr. Colin Driscoll
• Organization: Mayo Clinic, Rochester

driscoll.colin@mayo.edu

507 266 1965

Study Officials

• Colin Driscoll, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

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: April 14, 2011
• First Posted: April 18, 2011
• Study Start: May 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: October 27, 2016
• Results First Posted: September 25, 2014

Record last verified: 2016-09

Locations

US (1)