Evaluation of a Revised Indication for Determining Adult Cochlear Implant Candidacy

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Cochlear
ClinicalTrials.gov Identifier:
NCT01337076
First received: April 14, 2011
Last updated: October 7, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Hearing Loss
Device: cochlear implant

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of a Revised Indication for Determining Adult Cochlear Implant Candidacy

Resource links provided by NLM:


Further study details as provided by Cochlear:

Primary Outcome Measures:
  • Six months CNC word scores in the CI alone condition [ Time Frame: six months ] [ Designated as safety issue: No ]
    Efficacy of the revised current cochlear implant indications will be determined using a comparison between preoperative (ear to be implanted) and postoperative (cochlear implant alone) outcome measures. The primary study endpoint, 6 months postimplant activation, will be a statistically significant difference between the mean, preoperative CNC word score (ear to be implanted) and the postoperative (cochlear implant alone) score for candidates who currently perform outside the approved cochlear implant indications.


Estimated Enrollment: 60
Study Start Date: May 2012
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
cochlear implant Device: cochlear implant
Cochlear implant surgery
Other Name: implantable hearing device

Detailed Description:

Existing research, as discussed, supports the opinion that current candidacy criteria are set conservatively. The Sponsor, in addition to the support of recent peer reviewed literature illustrating a need for an appropriate criteria and more suitable speech recognition measure, believe it is appropriate at this time to re-evaluate the candidacy requirements associated with adult cochlear implantation. Specifically, this will be accomplished by evaluating the safety and efficacy of the Cochlear™ Nucleus® cochlear implant system under revised cochlear implant indications. The proposed approach would be to evaluate individuals scoring between 10 - 40% inclusively on monosyllabic words (CNC) who do not meet current approved speech perception criteria with the widely used sentence measure HINT in quiet. No change to current qualifying audiometric criteria (bilateral moderate to profound sensorineural hearing loss in the low frequencies and profound hearing loss in the mid to high speech frequencies) for implant candidacy is proposed.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01337076

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Cochlear
Investigators
Principal Investigator: Colin Driscoll, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Cochlear
ClinicalTrials.gov Identifier: NCT01337076     History of Changes
Other Study ID Numbers: CAM-EXP-A2010-01
Study First Received: April 14, 2011
Last Updated: October 7, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hearing Loss
Deafness
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014