Cochlear Implant With Dexamethasone Eluting Electrode Array

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

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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