Evaluation of a Revised Indication for Determining Adult Cochlear Implant Candidacy
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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 |
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| Contact: Kathryn Henion | 19723853471 | khenion@cochlear.com |
| United States, Minnesota | |
| Mayo Clinic | Recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Principal Investigator: Colin Driscoll, MD | |
| 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: | September 19, 2012 |
| 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 May 16, 2013