Scalar Localization Cochlear Electrode Array Using 64 Slice CT

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00587262
First received: December 21, 2007
Last updated: September 23, 2009
Last verified: September 2009
  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: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Scalar Localization of Cochlear Implant Electrode Array in Hearing Preservation Patients Using 64 Slice CT

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
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.

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
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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 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 September 18, 2014