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Completed

NCT Number: NCT00587262

Scalar Localization Cochlear Electrode Array Using 64 Slice CT

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.

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Key information

Conditions

Hearing Loss Ear Diseases Hearing Disorders Hearing Loss, High-Frequency Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

8 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Jan 7, 2008
Registry last updated
Jan 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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