Scalar Localization Cochlear Electrode Array Using 64 Slice CT

Hearing Loss Clinical Trial

Official title:

Scalar Localization of Cochlear Implant Electrode Array in Hearing Preservation Patients Using 64 Slice CT

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00587262
• Other study ID #: 06-004832
• Status: Completed
• Phase: N/A
• First received: December 21, 2007
• Last updated: December 30, 2015
• Start date: October 2006
• Est. completion date: September 2009

Study information

• Verified date: September 2009
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 100 Years

Eligibility

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).

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Deafness
• Hearing Loss

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

References & Publications (1)

Lane JI, Witte RJ, Driscoll CL, Shallop JK, Beatty CW, Primak AN. Scalar localization of the electrode array after cochlear implantation: clinical experience using 64-slice multidetector computed tomography. Otol Neurotol. 2007 Aug;28(5):658-62. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The aim of our study is to determine surgical placement of the short electrode of cochlear implants in patients with high frequency loss.		Two years	No
Secondary	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.		Two Years	No

External Links

•   Mayo Clinic Clinical Trials