Cochlear Implant With Dexamethasone Eluting Electrode Array

  • STATUS
    Recruiting
  • End date
    Jul 19, 2024
  • participants needed
    120
  • sponsor
    Cochlear
Updated on 19 September 2021
cochlear implant
dexamethasone
sensorineural hearing loss
hard of hearing
audiogram

Summary

An evaluation of Cochlear's cochlear implant electrode array which passively elutes dexamethasone for a defined period of time to help reduce inflammatory responses.

Description

The primary objectives of the pivotal evaluation is to show the efficacy of the dexamethasone eluting electrode through reduction in electrode impedances as compared to a standard electrode and the improvement of speech recognition from preoperative baseline. The secondary objectives are to assess the benefit-risk balance of a dexamethasone eluting electrode as similar to a standard electrode by comparison of adverse events and speech outcomes.

Details
Condition Sensorineural hearing loss, Hearing Loss, Bilateral hearing loss, Auditory Loss and Deafness, Hearing Impairment
Treatment CI632D, CI632
Clinical Study IdentifierNCT04750642
SponsorCochlear
Last Modified on19 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Post-lingual, bilateral, moderate ( 40 dB HL) to profound sensorineural hearing loss at 250, 500and 1000 Hz and profound high-frequency hearing loss, defined by a pure-tone average (PTA) threshold, 2000 through 8000 Hz, 90 dB HL
years or older at time of consent

Exclusion Criteria

Abnormal cochlear and middle ear anatomy
History with cochlear implant surgery
Allergy to dexamethasone
Women who are pregnant or plan to become pregnant
Unable/unwilling to comply to study requirements
Clear my responses

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