Cochlear Implant With Anti-Inflammatory Agent

Pilot Evaluation of Combined Investigational Device: CI4CID With Controlled Dosage of Dexamethasone

In an effort to further preserve residual acoustic hearing after cochlear implantation, it may be beneficial to incorporate anti-inflammatory agents into the electrode array for passive elution over a time course after implantation. This study aims to assess the ease and effectiveness of such an electrode design, and to assess the preliminary safety of use of such a device in the post-operative period. This study is a first-time-in-human study of the investigational device.

In the first instance, the aim of the current investigation is to obtain first experience in use of a Combined Device in the adult clinical population, and to assess tools and techniques that may be considered in future clinical studies of similar devices.

Study Overview

• Status: Completed
• Conditions: Hearing Loss
• Intervention / Treatment: Device: Contour Advance electrode with controlled dose of dexamethasone base; Device: Contour Advance electrode

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3053
      • The HEARing CRC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Duration severe to profound hearing impairment in implanted ear of less than or equal to 30 years
2. Post-lingual hearing impairment defined as onset of hearing loss at greater than two years of age
3. Evidence of Pneumovax vaccination within three years of implantation date (for subjects to be implanted with the investigational device)

Exclusion Criteria:

1. Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array or increased risk of infection (i.e. dysplastic cochlea), as confirmed by medical examination and imaging including MRI
2. Current use of grommets or evidence of tympanic membrane perforation
3. Known allergic reaction to dexamethasone or similar medicine
4. Diagnosis of Auditory Neuropathy
5. Active middle ear infection or history of middle ear infection within past two years
6. Unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure and use of the prosthetic device
7. Unwillingness or inability of the candidate to comply with all investigational requirements
8. Additional disabilities that would prevent or restrict participation in the audiological and medical evaluations required of the clinical investigation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CA with dexamethasone base; Contour Advance electrode with controlled dose of dexamethasone base	Device: Contour Advance electrode with controlled dose of dexamethasone base; The Combined Device consists of a standard cochlear implant receiver-stimulator coupled to a Contour Advance electrode loaded with a controlled dose of dexamethasone base.
Active Comparator: Contour Advance; Standard Contour Advance electrode array	Device: Contour Advance electrode; Standard Contour Advance electrode

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical feedback	Questionnaire used to obtain surgical feedback from experienced cochlear implant surgeons regarding the electrode design, and ease and effectiveness of surgery, when using the Combined Device as compared to the Contour Advance electrode	During surgery
Safety of Combined Device	Monitoring of device related adverse events that occur during the study period, to assess the preliminary safety of the Combined Device	Monitoring over 24 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Electrode impedance	Testing over 24 months
Electrically evoked compound action potential (ECAP)	Testing over 24 months

Collaborators and Investigators

• Sponsor: The Hearing Cooperative Research Centre
• Collaborators: St Vincent's Hospital Melbourne; Royal Victoria Eye and Ear Hospital; Cochlear; Royal Prince Alfred Hospital, Sydney, Australia; Westmead Hospital, New South Wales

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2013
• Primary Completion (Actual): November 6, 2017
• Study Completion (Actual): March 15, 2018

Study Registration Dates

• First Submitted: September 14, 2016
• First Submitted That Met QC Criteria: September 16, 2016
• First Posted (Estimate): September 19, 2016

Study Record Updates

• Last Update Posted (Actual): July 6, 2021
• Last Update Submitted That Met QC Criteria: July 2, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Dexamethasone; cochlear implants; combined device
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone
• Other Study ID Numbers: CLTD 5495

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No