Evaluation of a Revised Indication for Determining Adult Cochlear Implant Candidacy

Completed · Not applicable

Conditions studied: Hearing Loss

In brief

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.

Key facts

Study ID

NCT01337076

Run by

Cochlear

People needed

21

Starts

2012-05-01

Expected to finish

2014-01-01

Last updated by the study team

2016-10-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

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.

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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