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Scalar Localization Cochlear Electrode Array Using 64 Slice CT

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ClinicalTrials.gov Identifier: NCT00587262
Recruitment Status : Completed
First Posted : January 7, 2008
Last Update Posted : January 1, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease
Hearing Loss

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.


Study Design

Study Type : Observational
Actual Enrollment : 5 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Scalar Localization of Cochlear Implant Electrode Array in Hearing Preservation Patients Using 64 Slice CT
Study Start Date : October 2006
Primary Completion Date : September 2009
Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
1
Two pediatric participants with high frequency hearing loss post cochlear implant with either long or short electrode array.
2
Eight participants with high frequency hearing loss post cochlear implant with either short or long electrode array.
3
Fifteen participants from the existing Cochlear Implant data base.


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 100 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00587262


Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: John (Jack) I. Lane, M.D. Mayo Clinic
More Information

Additional Information:
Publications:
Responsible Party: John Lane, Professor of Radiology, College of Medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00587262     History of Changes
Other Study ID Numbers: 06-004832
First Posted: January 7, 2008    Key Record Dates
Last Update Posted: January 1, 2016
Last Verified: September 2009

Keywords provided by John Lane, 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