Cochlear Implant With Dexamethasone Eluting Electrode Array

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Cochlear

Status

Active, not recruiting

Conditions

Bilateral Hearing Loss
Sensorineural Hearing Loss

Treatments

Device: CI632D
Device: CI632

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT04750642
CLTD5759

Details and patient eligibility

About

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

Full 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.

Enrollment

120 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.
  • 18 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

120 participants in 2 patient groups, including a placebo group

CI632D Investigational Medical Device (IMD)
Experimental group
Treatment:
Device: CI632D
CI632 Comparator Device
Placebo Comparator group
Treatment:
Device: CI632

Trial contacts and locations

0

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Central trial contact

Minal Global Clinical Project Manager

Data sourced from clinicaltrials.gov

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