Cochlear Implant With Dexamethasone Eluting Electrode Array

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-04

Study Completion Date

2024-02-23

Brief Summary

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

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Detailed Description

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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.

Conditions

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Sensorineural Hearing Loss Bilateral Hearing Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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CI632D Investigational Medical Device (IMD)

Group Type EXPERIMENTAL

CI632D

Intervention Type DEVICE

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

CI632 Comparator Device

Group Type ACTIVE_COMPARATOR

CI632

Intervention Type DEVICE

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

Interventions

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CI632D

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

Intervention Type DEVICE

CI632

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No