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Safety and Efficacy of a Drug Eluting Slim Modiolar Electrode Array | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGNA

Safety and Efficacy of a Drug Eluting Slim Modiolar Electrode Array

A Pivotal, Prospective, Multicentre, Single-arm Study Evaluating the Safety and Efficacy of a Dexamethasone Eluting Slim Modiolar Electrode Array (EA32D).

NCT06598059•Cochlear

View on ClinicalTrials.gov

Summary

This clinical study will test a new type of cochlear implant known as CI632D. This experimental cochlear implant has been designed to slowly release a drug called dexamethasone. Dexamethasone works to ease inflammation and reduce tissue injury, which is common after any type of surgery. The goal is to learn if the dexamethasone in the CI632D implant lessens these reactions inside the ear following surgery and if this makes the implant work as well, or even better, in improving hearing than what would be expected with a standard cochlear implant. The study will be conducted in adults with sensorineural hearing loss, a type of hearing loss caused by damage to the inner ear or auditory nerve (the nerve that carries sound signals from the ear to the brain). The study participants will receive the CI632D experimental implant and will complete tests to see how well they are hearing and how well the implant is working.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•18 years or older, at time of consent.
•Postlinguistic moderately severe to profound sensorineural hearing loss, defined by a four frequency (500, 1000, 2000, 4000 Hz) pure-tone average unaided threshold (PTA4) ≥ 60 decibels hearing level (dB HL), in the ear to be implanted (For this study, moderately severe is defined by a four-frequency, pure-tone average threshold (PTA4) over the range 500 through 4000 Hz of more than 55 dB HL through 70 dB HL, inclusive. Profound is defined by a PTA4 of more than 90 dB HL).
•Pure-tone average unaided threshold (500 through 4000 Hz) ≥ 30 dB HL, in the contralateral ear.
•Preoperative aided word score ≤ 40% correct in the ear to be implanted.
•Evidence of pneumococcal vaccination (e.g., Pneumovax) according to local guidelines.
•Candidate is proficient in the language used to assess speech perception performance.
•Willing and able to provide written informed consent.

Exclusion Criteria

•Intra-axial (within the brain) lesions or deafness due to lesions of the acoustic nerve affecting the ear to be implanted.
•Middle ear infection (including acute otitis media, chronic otitis media, suppurative otitis media, or serous drainage) in the ear to be implanted either at the time of surgery or within 3 months prior to enrolment.
•Active autoimmune disease or active immunosuppressive therapy.
•Presence of a tympanic membrane perforation or a history of otologic surgery within 3 months prior to enrolment, in the ear to be implanted.
•Previously reported diagnosis of auditory neuropathy, in the ear to be implanted.
•Previously reported diagnosis, in the ear to be implanted, of Large Vestibular Aqueduct Syndrome (LVAS), Meniere's disease, or cochlear hydrops.
•Ossification, otosclerosis, malformation or any other cochlear anomaly, such as common cavity, that might prevent complete insertion of the electrode array, in the ear to be implanted.
•Current cerebrospinal fluid (CSF) shunts or drains, existing perilymph fistula, skull fracture or CSF leaks.
•Previously reported diagnosis of bacterial meningitis.
•Known allergic reaction or contraindication to dexamethasone or corticosteroids.
+12 more criteria

Locations (11)

UCLA Medical Center

Los Angeles, California, United States

Rocky Mountain Ear Center

Englewood, Colorado, United States

University of Iowa

Iowa City, Iowa, United States

Henry Ford Health

Detroit, Michigan, United States

Washington University

St Louis, Missouri, United States

New York Eye and Ear Infirmary

New York, New York, United States

NYU Langone Health

New York, New York, United States

Northwell Health Long Island Jewish Medical Center

New York, New York, United States

University Hospitals

Cleveland, Ohio, United States

Oregon Health & Science University

Portland, Oregon, United States

Key Dates

Start Date

January 3, 2025

Primary Completion Date

February 2, 2026

Completion Date

September 1, 2026

Last Updated

March 2, 2026

Enrollment

ACTUAL participants

Conditions

Hearing Loss

Interventions

Cochlear implant

DEVICE

Dexamethasone

DRUG

MED-EL HEARING SOLUTIONS (MEHS): AN OBSERVATIONAL STUDY

NCT05668338

Hearing Loss

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RECRUITINGNA

Preschool Hearing Screening

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Hearing LossHearing Disorders in Children+6 more

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RECRUITINGNA

Evaluation of Flexible Conductive Hearing Aids

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 2, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety and Efficacy of a Drug Eluting Slim Modiolar Electrode Array

Inclusion Criteria

Exclusion Criteria

MED-EL HEARING SOLUTIONS (MEHS): AN OBSERVATIONAL STUDY

Preschool Hearing Screening

Evaluation of Flexible Conductive Hearing Aids

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