Cochlear Implant With Anti-Inflammatory Agent

NCT ID: NCT02905305

Last Updated: 2021-07-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-10
• Study Completion Date: 2018-03-15

Brief Summary

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.

Conditions

Hearing Loss

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CA with dexamethasone base

Contour Advance electrode with controlled dose of dexamethasone base

Group Type: EXPERIMENTAL

Contour Advance electrode with controlled dose of dexamethasone base

Intervention Type: DEVICE

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.

Contour Advance

Standard Contour Advance electrode array

Group Type: ACTIVE_COMPARATOR

Contour Advance electrode

Intervention Type: DEVICE

Standard Contour Advance electrode

Interventions

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.

Intervention Type: DEVICE

Contour Advance electrode

Standard Contour Advance electrode

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cochlear

INDUSTRY

Sponsor Role: collaborator

Royal Victoria Eye and Ear Hospital

OTHER_GOV

Sponsor Role: collaborator

Royal Prince Alfred Hospital, Sydney, Australia

OTHER

Sponsor Role: collaborator

St Vincent's Hospital Melbourne

OTHER

Sponsor Role: collaborator

Westmead Hospital, New South Wales

UNKNOWN

Sponsor Role: collaborator

The Hearing Cooperative Research Centre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The HEARing CRC

Melbourne, Victoria, Australia

Countries

Australia

Other Identifiers

CLTD 5495

Identifier Type: -

Identifier Source: org_study_id