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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Faculty / Staff Research

Arenberg J,  Furukawa S, Middlebrooks J.   Auditory cortical images of cochlear electrical stimulation.
    Conference on Implantable Auditory Prostheses, August, 1999, accepted poster.

Ashbaugh CJ, El-Kashlan H, Zwolan TA.  Cochlear implant use in children with multiple disabilities.
    Abstract submitted for poster presentation at Miami meeting in February 2000.
   

Ashbaugh C, Zwolan TA. Matched Pairs Comparison of Speech Perception Skills of Cochlear Implant Recipients and Hearing Aid Users Enrolled in the Same Classrooms.
    Presented at the 7th Symposium on Cochlear Implants in Children. Iowa City, Iowa, June, 1998.

Boerst A, Ashbaugh CJ.  Mainstreaming of children with cochlear implants.
    Abstract submitted for presentation at Miami meeting in February 2000.

C Connor, S. Hieber, H.A. Arts, T. Zwolan.  Speech, Vocabulary, and the Education of Children Using Cochlear Implants:  Oral or Total Communication?
    Resubmitted to Journal of Speech and Hearing Research, August, 1999.

Eisenman D, Ashbaugh CJ, Zwolan TA.Telian, SA.  Cochlear implantation in malformed cochleas.
    Abstract submitted for presentation at Miami meeting in February, 2000.
    To be submitted for publication in the future.

El-Kashlan H, Ashbaugh C, Zwolan T, Telian SA.  Cochlear implantation in prelingually deaf children with ossified cochleae.
    Abstract submitted for presentation at Miami meeting in February 2000.
    To be submitted for publication in future.

Franck KH, Norton SJ.  The Electrically Evoked Whole-nerve Action Potential:  Fitting Applications for Cochlear Implant Users.
      Accepted for poster presentation at the 1999 Conference on Implantable Auditory Prostheses, Asilomar, CA.  August, 1999.
      To be submitted for publication.

Franck KH, Pfingst BE.  The Clinical Use of a Cochlear Implant Fitting Protocol Based on the Electrically Evoked Compaound Action Potential.
      Grant proposal submitted to the American Hearing research Foundation.

Hieber S, Connor CM, Ashbaugh CJ, Zwolan TA.  Comparison of Speech Recognition Abilities of Children with Cochlear Implants Enrolled in Oral and Total Communication Programs.
    Presented at the Cochlear Implant Symposium, New York, May 1997.

Kileny PR.
    Featured speaker at Miami meeting in February 2000.

Middlebrooks J, Arenberg J.  Cortical phase locking to modulated pulse-train stimulation of a cochlear implant.
    Conference on Implantable Auditory Prostheses, August, 1999, accepted poster.

Miller, A., and Pfingst, B. 1999. Effects of deafness and chronic stimulation on spiral ganglion cell survival and psychophysical detection thresholds.
    Conference on Implantable Auditory Prostheses, August, 1999, accepted poster.

Morris, D., and Pfingst, B. 1999. Effects of stimulus level and electrode configuration on rate and level discrimination.
    Conference on Implantable Auditory Prostheses, August, 1999, accepted poster.

Pfingst, BE, Montney, LM, Bledsoe, SC Jr, Arenberg, JG, and Middlebrooks, JC. Neural response patterns evoked by various electrode configurations at equal-loudness levels.
    Conference on Implantable Auditory Prostheses, August, 1999, invited presentation.

Pfingst, BE, Zwolan, TA, Franck, KH, Features of Hearing Important for Electrical Hearing.
    Ongoing research.

Zwolan TA.
    Featured speaker at Miami meeting in February 2000.

Zwolan TA, Osberger MJ, Fisher L. The Relationship between sound quality rating, strategy preference, and speech recognition with the Clarion Multi-Strategy Cochlear Implant.
    Accepted for poster presentation at the 1999 Conference on Implantable Auditory Prostheses, Asilomar, CA.  August, 1999.
    To be submitted for publication following Asilomar meeting.