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FDA
Trials
A clinical
trial is required by the FDA before a new cochlear implant device
is approved for the general public. The FDA requires separate
trials for different populations (adults vs. children). The University
of Michigan Cochlear Implant Program has been involved in many
clinical trials which have led to the approval of all currently
available cochlear implant systems.
Each manufacturer
organizes the trial and selects a set number of clinical sites
to work with new devices and/or populations to collect data. Clinical
trials may have stricter criteria for who is a candidate. This
may sometimes preclude adults who have a prelingual onset of hearing
loss or someone who has ossified cochleas (bony growth). Participating
in a clinical trial may also require more time for the participant
as the FDA may require additional testing be completed.
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The University
of Michigan Cochlear Implant program encourages and promotes clinical
research by its staff. This section of the website is currently
under construction to update the many presentations and papers
that have been presented recently. Please visit the Kresge
Hearing Reseach Institute website for the latest on their
research projects, and check back at a future date for the latest
on clinical research being conducted in the clinic.
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