Evaluation of a Revised Indication for Determining Adult Cochlear Implant Candidacy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cochlear
ClinicalTrials.gov Identifier:
NCT01337076
First received: April 14, 2011
Last updated: September 18, 2014
Last verified: September 2014

April 14, 2011
September 18, 2014
May 2012
January 2014   (final data collection date for primary outcome measure)
CNC Monosyllabic Word Score - Treated Ear [ Time Frame: Six months ] [ Designated as safety issue: No ]

The primary study endpoint will be a statistically significant difference 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 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.
Complete list of historical versions of study NCT01337076 on ClinicalTrials.gov Archive Site
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Evaluation of a Revised Indication for Determining Adult Cochlear Implant Candidacy
Evaluation of a Revised Indication for Determining Adult Cochlear Implant Candidacy

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.

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 Consonant Nucleus Consonant (CNC) monosyllabic words who do not meet current approved speech perception criteria with the widely used sentence measure Hearing In Noise Test (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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hearing Loss
Device: cochlear implant
Cochlear implant surgery
Other Name: implantable hearing device
cochlear implant
Intervention: Device: cochlear implant
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
January 2014
January 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01337076
CAM-EXP-A2010-01
No
Cochlear
Cochlear
Not Provided
Principal Investigator: Colin Driscoll, MD Mayo Clinic
Cochlear
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP