- They are only offered at specific clinical trial sites. These trial site clinics are experienced MED-EL hearing implant centers where the staff is specially trained to follow all of the important guidelines for conducting research.
- They are only available to candidates who meet very specific criteria and who are formally accepted by the site and the company as a clinical trial participant.
- Candidates must be fully informed of all known or anticipated risks and the expected benefits of participation in the study. Candidates receive specific counseling and sign a detailed informed consent prior to undergoing the surgery.
- All clinical trial data must be submitted to FDA, accepted, and market approval granted before the device can be made available to the general public.
The pages that follow will describe two devices that are currently in clinical trial in the United States:
- The EAS Electric-Acoustic Stimulation System, which uses the FLEXeas electrode array and the DUET processor, is in trial for adults with normal to moderate hearing levels in the low frequencies, sloping to severe/profound hearing loss in the high frequencies. These individuals currently have too much residual hearing to qualify for a traditional cochlear implant procedure but do not benefit adequately from conventional hearing aids.
- The Vibrant Soundbridge Middle Ear Implant System, with the FMT strategically placed in the round window, is in trial for adults who have conductive or mixed hearing loss, do not benefit from traditional hearing aids and currently do not qualify for a traditional middle ear implant procedure.
Opportunities are often available for existing MED-EL hearing implant recipients to participate in ongoing research studies. Candidacy and participation requirements vary depending upon the specific study project. Testing, for instance, may involve listening to speech in the presence of varying levels of background noise, or identifying musical instruments, or completing surveys related to your experience with your current hearing implant.
Information related to projects that are currently open for enrollment is provided on this webpage. If you are a MED-EL hearing implant recipient and are interested in one of these research opportunities, please contact the affiliated research center for further details related to study participation.
DeVault Otologic Research Laboratory
Utah State University
Department of Hearing & Speech Sciences
The Vanderbilt Bill Wilkerson Center is currently seeking adult research participants who have bilateral MED-EL cochlear implants.
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