Cochlear Implant With Dexamethasone Eluting Electrode Array

Cochlear42 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Sensorineural Hearing Loss Bilateral Hearing Loss

Interventions

CI632DDEVICE

CI632 cochlear implant with Slim Modiolar electrode including dexamethasone in the electrode within wells (CI632D)

CI632DEVICE

CI632 cochlear implant with Slim Modiolar electrode with market approval and does not include dexamethasone

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (8)

Rocky Mountain Ear Centre

Englewood, Colorado, United States

University of Iowa

Iowa City, Iowa, United States

New York Eye & Ear infirmary of Mt. Sinai

New York, New York, United States

NYU Langone Medical Center

New York, New York, United States

Outcomes

Primary Outcomes

Comparison of Monopolar (MP1+2) Impedance Measurement (kOhms) Between Randomization Groups at 6 Months Postoperative

The impedance was measured across the active electrodes of the cochlear implant for each participant. Reduced impedances indicate less fibrotic obstruction caused by trauma associated with the electrode insertion.

Time frame: Six months postoperative

Change in Speech Perception Performance (Pre-recorded CNC Words in Quiet in Sound Booth Testing) Compared to Pre-operative Baseline Measured at 6 Months Postoperative With CI632D

Scores on the CNC Words in Quiet test were expressed as a percentage of words repeated correctly by the participant in a sound booth. A higher score indicates better speech perception performance. This outcome measure included the CI632D group only.

Time frame: Six months postoperative

Secondary Outcomes

Comparison of Rate and Type of Device Related Adverse Events Between Randomization Groups

Adverse events were recorded from baseline to 12 months postoperative.

Time frame: Twelve months postoperative

Comparison of Speech Perception Performance (Pre-recorded CNC Words in Quiet in Sound Booth Testing) Between the Randomization Groups at Six Months Postoperative

Scores on the CNC Words in Quiet test were expressed as a percentage of words repeated correctly by the participant in a sound booth. A higher score indicates better speech perception performance.

Time frame: Six months postoperative

Comparison of Speech Perception Performance (AzBio Sentences in Quiet in Sound Booth Testing) Between Randomization Groups at Six Months Postoperative

Scores from the AzBio Sentences in Quiet test were expressed as a percentage of words repeated correctly by the participant in a sound booth. A higher score indicates better speech perception performance.

Data from ClinicalTrials.gov

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