IRB Number:

08-001983

Trial Status:

Open for Enrollment

Phase: III

Why is this study being done?

The purpose of this study is to evaluate the safety and efficacy associated with the provision of acoustic and electric sound processing to individuals who demonstrate significant residual low-frequency hearing and profound high-frequency (above 1500 Hz) sensorineural hearing loss. Delivery of acoustic-electric stimulation will be provided by the Nucleus® Hybrid L24 cochlear implant system.

Who is Eligible to Participate in the Study?

Participants eighteen years of age or older who demonstrate significant residual low-frequency hearing and profound high-frequency (above 1500 Hz) sensorineural hearing loss.

Minimum Age:

18

Maximum Age:

99

What is Involved With this Study?

If you agree to be in the study, you will be asked to complete a number of preoperative (before surgery) evaluations, and undergo cochlear implant surgery. Participants may require one or more medical appointments during their recovery from surgery and will attend up to 6 postoperative (after surgery) study-related appointments over a 1-year period and then semi-annually until the Sponsor closes the study.

How long will the Study run?

Participants will be enrolled in this study for approximately 2 to 3 years, though the majority of the postoperative evaluations will take place in the initial 12 months following surgery.

Who can I Contact for Additional Information on this Trial?

Dr Colin Driscoll, 507-284-4065

Dr Rene Gifford, 507-266-1965

What is/are the Locations of this Clinical Trial?

• Rochester, MN

Last updated: 07/24/2009