N/A
N=21
Evaluation of a Revised Indication for Determining Adult Cochlear Implant Candidacy
Hearing Loss
Bottom Line
View on ClinicalTrials.gov: NCT01337076 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Sep 2014
Primary outcome: Primary: CNC Monosyllabic Word Score - Treated Ear — 57.1 percent correct
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- cochlear implant (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cochlear
- Primary completion
- Jan 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY CNC Monosyllabic Word Score - Treated Ear |
57.1 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01337076). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.