Performance and Hearing-related Outcomes in Adults Implanted With the CI622D Dexamethasone-eluting Cochlear Implant Compared to Those Implanted With a Standard Cochlear Implant (CI622) (DETECT)

A Pivotal, Prospective, Multi-centre, Randomised Controlled, Blinded Investigation Evaluating the Efficacy of a Dexamethasone Eluting Slim Straight Electrode (CI622D) in the Reduction of Impedance as Compared to a Standard Slim Straight Electrode (CI622) in a Newly Implanted Adult Population With Post-linguistic, Bilateral, Moderately Severe to Profound Sensorineural Hearing Loss.

This clinical study will test a newly developed cochlear implant known as CI622D. This experimental cochlear implant has been designed to slowly release a drug called dexamethasone. Dexamethasone works to ease inflammation, which is common after any surgical procedure. The goal is to learn if there are added benefits in implant performance and hearing outcomes with the dexamethasone-releasing cochlear implant (CI622D) vs. the standard cochlear implant (CI622) without dexamethasone. 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 study participants will undergo a series of tests that include testing their implant and their hearing. They will also complete questionnaires to see how they rate their hearing ability and their overall general health.

Study Overview

• Status: Not yet recruiting
• Conditions: Hearing Loss, Sensorineural; Hearing Loss, Bilateral; Hearing Loss, Cochlear; Hearing Loss, Bilateral Sensorineural
• Intervention / Treatment: Device: CI622D; Device: CI622

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

Contacts and Locations

• Study Contact: Name: Cherith Campbell-Bell; Phone Number: +6129428 6555; Email: ccampbellbell@cochlear.com
• Study Contact Backup: Name: Beatrice Reusens; Phone Number: +32485759196; Email: breusens@cochlear.com

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia
      • Royal Prince Alfred Hospital
      • Contact: Catherine Birman, MD
      • Principal Investigator: Catherine Birman
  • Victoria
    • Melbourne E., Victoria, Australia
      • Royal Victorian Eye and Ear Hospital
      • Contact: Stephen O'Leary, MD
      • Principal Investigator: Stephen O'Leary
• France
  • Lille, France
    • Centre Hospitalier Universitaire de LILLE
    • Contact: Christophe Vincent, MD
    • Principal Investigator: Christophe Vincent, MD
  • Paris, France
    • Hôpital Universitaire Pitié-Salpêtrière
    • Principal Investigator: Isabelle Mosnier
    • Contact: Isabelle Mosnier, MD
  • Toulouse, France
    • Centre Hospitalier Universitaire Toulouse
    • Contact: Olivier Deguine, MD
    • Principal Investigator: Olivier Deguine
• Germany
  • Freiburg Im Breisgau
    • Freiburg, Freiburg Im Breisgau, Germany
      • Universitätsklinikum Freiburg
      • Contact: Antje Aschendorff, MD
      • Principal Investigator: Antje Aschendorff
  • Niedersachsen
    • Hannover, Niedersachsen, Germany
      • Medizinische Hochschule Hannover
      • Contact: Thomas Lenarz, MD
      • Principal Investigator: Thomas Lenarz
• United Kingdom
  • Manchester, United Kingdom
    • Manchester Royal Infirmary
    • Contact: Emma Stapleton, MD
    • Principal Investigator: Emma Stapleton, MD
  • Southampton, United Kingdom
    • University of Southampton
    • Contact: William Hellier, MD
    • Principal Investigator: William Hellier, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Aged 18 years or older (at time of consent)
• Clinically established post-linguistic bilateral moderately severe to profound sensorineural hearing loss
• Meets local candidacy criteria for cochlear implantation
• Compromised functional hearing with a hearing aid in the ear to be implanted
• Willing to participate in and comply with all requirements of the protocol, including willingness to be randomised to either arm
• Evidence of pneumococcal vaccination (e.g., Pneumovax) according to local guidelines prior to randomisation
• Candidate is proficient in the language used to assess speech perception performance
• Willing and able to provide written informed consent.

Exclusion Criteria:

• Planned for a partial insertion of the electrode array
• Deafness due to lesions of the acoustic nerve or central auditory pathway, affecting either ear
• Active middle-ear infection, in the ear to be implanted
• Active autoimmune disease, active immunosuppressive therapy, or use of anticoagulants that cannot be discontinued for surgery
• Surgery (including grommets), drainage, presence of an unhealed tympanic membrane, pain, or need for oral or topical antibiotics within 6 months prior to randomisation, in the ear to be implanted
• Previously reported diagnosis of auditory neuropathy, in either ear
• Previously reported diagnosis, in either ear, 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, as confirmed by imaging, in the ear to be implanted
• Current cerebrospinal fluid (CSF) shunts or drains, existing perilymph fistula, temporo-parietal skull fracture or CSF leaks
• History 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
• Severe, or poorer, sensorineural hearing loss of 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
• Women who are pregnant or breastfeeding or plan to become pregnant during the investigation
• Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure(s) and prosthetic devices as determined by the Investigator
• Additional disabilities that may affect the subject's participation or safety during the clinical investigation, as determined by the Investigator
• Unable or unwilling to comply with 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 to the study candidate
• 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 the other investigation was/is a Cochlear sponsored investigation and determined by the Investigator or Sponsor to not impact this investigation)
• Subjects recruited at a French site who are not affiliated with social security
• Subjects recruited at a French site who are under legal protection.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CI622D; Investigational Medical Device (IMD)	Device: CI622D; A dexamethasone-eluting Slim Straight electrode
Active Comparator: CI622; An approved medical device	Device: CI622; A standard Slim Straight electrode

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean difference in the monopolar 1+2 (MP1+2) impedance between CI622D (Investigational Medical Device) and CI622 (control device) at 3 months post-activation	The impedance will be measured across the active electrodes of the implant for each participant.	3 months post-activation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants who experience an adverse event and the proportion of participants who experience a device deficiency with CI622D and CI622	Adverse events will be recorded as overall, by severity, by relatedness to device or procedure, or by seriousness. Device deficiency will be recorded as overall and by type.	Throughout study (12 months)
Difference in the mean unaided acoustic hearing thresholds pre-operatively, and from activation to post-activation between CI622D and CI622	Unaided acoustic hearing thresholds will be measured pre-operatively, at activation, and 3, 6 and 12 months post-activation.	Pre-operative, 0, 3, 6, 12 months post-activation
Mean within-subject change in word recognition score in the preferred unilateral listening mode in quiet from pre-implantation to post-activation with CI622D	Word recognition scores will be measured at pre-implantation and 3, 6 and 12 months post-activation.	Pre-implantation, 3, 6, 12 months post-activation
Mean change (within-subject) in word recognition score in the preferred bilateral listening mode in quiet from pre-implantation to post-activation with CI622D	Word recognition scores will be measured at pre-implantation and 3, 6 and 12 months post-activation.	Pre-implantation, 3, 6, 12 months post-activation
Difference in mean (within-subject) change in word recognition score in the preferred unilateral listening mode in quiet from pre-implantation to post-activation with CI622D compared with CI622	Change in word recognition score will be measured from pre-implantation to 3, 6 and 12 months post-activation.	Pre-implantation, 3, 6, 12 months post-activation
Difference in mean (within-subject) change in word recognition score in the preferred bilateral listening mode in quiet from pre-implantation to post-activation with CI622D compared with CI622	Change in word recognition score will be measured from pre-implantation to 3, 6 and 12 months post-activation.	Pre-implantation, 3, 6, 12 months post-activation
Difference in mean (within-subject) change in sentence recognition score in noise in the preferred unilateral listening mode from pre-implantation to post-implantation with CI622D compared with CI622	Change in sentence recognition score (Matrix test + 10 SNR) will be measured from pre-implantation to 3, 6 and 12 months post-activation.	Pre-implantation, 3, 6, 12 months post-activation
Difference in mean (within-subject) change in sentence recognition score in noise in the preferred bilateral listening mode from pre-implantation to post-implantation with CI622D compared with CI622	Change in sentence recognition score (Matrix test + 10 SNR) will be measured from pre-implantation to 3, 6 and 12 months post-activation.	Pre-implantation, 3, 6, 12 months post-activation
Difference in the mean four-point monopolar and nested bipolar trans-impedances and MP1+2 impedances between CI622D and CI622 measured intraoperatively and from activation to post-activation	Four-point monopolar and nested bipolar trans-impedances and MP1+2 impedances will be measured intraoperatively, at activation and 3,6,12 months post-activation.	Intraoperative, 0, 3, 6, 12 months post-activation
Difference in the mean estimated sound processor battery life for CI622D compared from activation to post-activation with CI622	The estimated sound processor battery life (hours per day) will be measured at activation, 3, 6, and 12 months-post activation.	0, 3, 6,12 months post-activation
Difference in mean within-subject changes in global score on the Speech, Spatial, and Qualities of Hearing Scale (SSQ12) from pre-implantation to post-activation between CI622D and CI622	Global SSQ12 scores will be measured between pre-implantation to 3, 6 and 12 months post-activation.	Pre-implantation, 3, 6, 12 months post-activation
Difference in mean within-subject changes in global Health Utilities Index III (HUI3) from pre-implantation to post-activation between CI622D and CI622	Global HUI3 scores will be measured between pre-implantation to 3, 6 and 12 months post-activation.	Pre-implantation, 3, 6, 12 months post-activation

Collaborators and Investigators

• Sponsor: Cochlear
• Collaborators: Avania; QbD Clinical
• Investigators: Principal Investigator: Antje Aschendorff, Universitätsklinikum Freiburg

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: May 16, 2024
• First Submitted That Met QC Criteria: May 16, 2024
• First Posted (Actual): May 22, 2024

Study Record Updates

• Last Update Posted (Actual): May 22, 2024
• Last Update Submitted That Met QC Criteria: May 16, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Deafness; Hearing Loss, Sensorineural; Hearing Loss, Bilateral
• Other Study ID Numbers: CLTD5815

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No