Cochleostomy vs Round Window for Hearing Preservation in CI

• Research type

  Research Study

• Full title

  Round window versus cochleostomy electrode array insertion with lateral wall atraumatic electrode: a prospective randomised clinical study

• IRAS ID

  63284

• Contact name

  Shakeel Saeed

• Contact email

  shakeel.saeed@ucl.ac.uk

• Sponsor organisation

  University College London

• ISRCTN Number

  ISRCTN00000000

• Clinicaltrials.gov Identifier

  NCT00000000

• Duration of Study in the UK

  2 years, 0 months, 1 days

• Research summary

  The lateral wall atraumatic electrode array is designed to cause as little damage as possible on insertion into the cochlea, either through the "round window" of the cochlea or by making a hole in the bony wall of the cochlea: a so-called cochleostomy. Both approaches (round window and cochleostomy insertion)are standard clinical procedure that are used in cochlear implant surgery and used based on surgeons' preference.
  There is some evidence to suggest that this type of implant, along with "hearing preservation" surgical techniques, can preserve residual hearing. However, at this time the following have not been completed:
  a) A prospective (rather than retrospective) systematical study of hearing preservation
  b) A prospective analysis comparing round window insertion and cochleostomy insertion.

  This study therefore will involve the insertion of lateral wall atraumatic electrode array cochlear implant in 54 patients using either round window insertion or cochleostomy insertion. Data will be gathered before, during and after the operation and compared between the two groups. Comparison will also be made between hearing preservation, audiological and physiological measurements and radiological assessment following a cone-beam CT scan. Conclusions drawn from the study will help us to understand how best to preserve hearing following cochlear implantation and the benefits of both insertion techniques.

  This study is part of PhD student project. The student will be responsible for the instigation of the study, and the collation and analysis of the data. This will be under the supervision of the Chief Investigator, who is also the primary PhD supervisor.

• REC name

  London - Bloomsbury Research Ethics Committee

• REC reference

  18/LO/1405

• Date of REC Opinion

  10 Sep 2018

• REC opinion

  Favourable Opinion