Scalar Localization Cochlear Electrode Array Using 64 Slice CT
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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 |
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Hearing Loss |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Scalar Localization of Cochlear Implant Electrode Array in Hearing Preservation Patients Using 64 Slice CT |
- The aim of our study is to determine surgical placement of the short electrode of cochlear implants in patients with high frequency loss. [ Time Frame: Two years ] [ Designated as safety issue: No ]
- 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. [ Time Frame: Two Years ] [ Designated as safety issue: No ]
| Enrollment: | 5 |
| Study Start Date: | October 2006 |
| Study Completion Date: | September 2009 |
| Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
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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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Detailed Description:
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:
- Registered in the Cochlear Implant Database.
- Patient has short or long electrode cochlear implant for high frequency hearing loss.
Exclusion Criteria:
- Inability to provide consent.
- Patients with underlying otospongiosis, extensive labyrinthitis ossificans or cochlear dysplasia. (These patients would have been identified with pre-operative imaging prior to cochlear implantation).
Contacts and Locations More Information
Additional Information:
Publications:
| Responsible Party: | John I. (Jack) Lane, M.D., Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT00587262 History of Changes |
| Other Study ID Numbers: | 06-004832 |
| Study First Received: | December 21, 2007 |
| Last Updated: | September 23, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Mayo Clinic:
|
Cochlear Hearing High frequency hearing loss |
Additional relevant MeSH terms:
|
Hearing Loss Deafness Hearing Disorders Ear Diseases Otorhinolaryngologic Diseases |
Sensation Disorders Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on May 21, 2013