Testing a new cochlear implant that releases a drug to improve hearing

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

This study tests a new cochlear implant that releases a medication to see if it can help adults with hearing loss hear better than regular implants.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 56 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Cochlear (Industry-sponsored)
• Locations: 9 sites (Englewood, Colorado and 8 other locations)
• Trial ID: NCT06598059 on ClinicalTrials.gov

What this trial studies

This clinical study evaluates a novel cochlear implant, CI632D, designed to release dexamethasone, a drug that reduces inflammation and tissue injury post-surgery. The study aims to determine if this drug-eluting implant enhances hearing outcomes compared to standard cochlear implants in adults with sensorineural hearing loss. Participants will receive the experimental implant and undergo hearing assessments to evaluate its efficacy. The focus is on understanding the safety and effectiveness of this innovative approach in improving auditory function.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with moderately severe to profound sensorineural hearing loss.

Not a fit: Patients with intra-axial brain conditions or those who do not meet the hearing loss criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to better hearing outcomes for patients with cochlear implants by minimizing post-surgical complications.

How similar studies have performed: Other studies have explored drug-eluting implants, showing promise in reducing inflammation, but this specific approach is relatively novel.

Eligibility criteria

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.
* Severe, or poorer, bilateral sensorineural hearing loss prior to 5 years of age, as reported by the subject. (For this study, severe is defined by a PTA4 of more than 70 dB HL through 90 dB HL, inclusive).
* Severe, or poorer, sensorineural hearing loss for more than 20 years, as reported by the subject, in the ear to be implanted.
* Prior cochlear implantation in either ear.
* Medical plan for cochlear implantation during the clinical investigation, contralateral to the ear to be implanted.
* Medical or psychological conditions that contraindicate general anaesthesia, surgery, or participation in the clinical investigation as determined by the Investigator.
* Unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations inherent to the surgical procedure(s) and prosthetic devices, as determined by the Investigator.
* Women who are pregnant.
* Additional disabilities that may affect the subject's participation or safety during the clinical investigation.
* Unable or unwilling to comply with all the requirements of the clinical investigation as determined by the investigator.
* Investigator site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined as spouse, parent, child, or sibling.
* Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation.
* Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device unless Cochlear sponsored and determined by Investigator or Sponsor to not impact this investigation.

Where this trial is running

Englewood, Colorado and 8 other locations

• Rocky Mountain Ear Center — Englewood, Colorado, United States (Recruiting)
• University of Iowa — Iowa City, Iowa, United States (Recruiting)
• Washington University — St. Louis, Missouri, United States (Recruiting)
• New York Eye and Ear Infirmary — New York, New York, United States (Recruiting)
• NYU Langone Health — New York, New York, United States (Recruiting)
• Northwell Health Long Island Jewish Medical Center — New York, New York, United States (Recruiting)
• University Hospitals — Cleveland, Ohio, United States (Recruiting)
• Oregon Health & Science University — Portland, Oregon, United States (Recruiting)
• Medical University of South Carolina — Charleston, South Carolina, United States (Recruiting)

Study contacts

• Study coordinator: Aaron Parkinson, PhD

Conditions Hearing Loss; cochlear implant; dexamethasone; fibrosis