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| Sponsored by: |
Mayo Clinic |
|---|---|
| Information provided by: | Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT00587262 |
Purpose
Insertion of electrode array in scala vestibuli, rather than the preferred location within scala tympani, leads to loss of native hearing in those patients with isolated high-frequency hearing loss undergoing cochlear implantation.
| Condition |
|---|
|
Hearing Loss |
| Study Type: | Observational |
| Study Design: | Cohort, Prospective |
| Official Title: | Scalar Localization of Cochlear Implant Electrode Array in Hearing Preservation Patients Using 64 Slice CT |
| Estimated Enrollment: | 25 |
| Study Start Date: | October 2006 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
1
Two pediatric participants with high frequency hearing loss post cochlear implant with either long or short electrode array.
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|
2
Eight participants with high frequency hearing loss post cochlear implant with either short or long electrode array.
|
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3
Fifteen participants from the existing Cochlear Implant data base.
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We aim to determine the surgical placement in patients with high frequency who had long electrode array insertions because they did not meet audiometric criteria for short array devices.
From this basis we will be able to determine if suboptimal insertion (e.g., in the scala vestibuli) leads to loss of low-frequency hearing in these patients. We also will look at the possibilities of using this data in predicting outcomes, modifying implant design, and perfecting surgical technique.
Eligibility| Ages Eligible for Study: | 8 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Either part of the existing Cochlear Implant data base, or those persons who have had a Cochlear implant with either short or long electrode array who have had a high frequency hear loss.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Theresa A. Nielson | 507-538-2584 | nielson.theresa@mayo.edu |
| United States, Minnesota | |
| Mayo Clinic | Recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Principal Investigator: John (Jack) I. Lane, M.D. | |
| Principal Investigator: | John (Jack) I. Lane, M.D. | Mayo Clinic |
More Information
| Responsible Party: | Mayo Clinic ( John I. (Jack) Lane, M.D. ) |
| Study ID Numbers: | 06-004832 |
| Study First Received: | December 21, 2007 |
| Last Updated: | May 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00587262 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Cochlear Hearing High frequency hearing loss |
|
Signs and Symptoms Sensation Disorders Hearing Disorders Deafness |
Otorhinolaryngologic Diseases Neurologic Manifestations Hearing Loss Ear Diseases |
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Signs and Symptoms Sensation Disorders Hearing Disorders Deafness Otorhinolaryngologic Diseases |
Nervous System Diseases Neurologic Manifestations Hearing Loss Ear Diseases |