A Pivotal, Prospective, Multi-centre, Randomised Controlled, 6-month Blinded Investigation Followed by a 6-month Open-label Phase 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. (DETECT)

NCT06424262 NA ACTIVE_NOT_RECRUITING

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.

Details

Lead sponsor	Cochlear
Phase	NA
Status	ACTIVE_NOT_RECRUITING
Enrolment	48
Start date	2024-06-17
Completion	2026-05

Conditions

• Hearing Loss, Bilateral Sensorineural
• Hearing Loss, Sensorineural
• Hearing Loss, Bilateral
• Hearing Loss, Cochlear

Interventions

• CI622D
• CI622

Primary outcomes

• Difference in the mean monopolar 1+2 (MP1+2) impedance between CI622D (Investigational Medical Device) and CI622 (control device) at 6 months post-activation — 6 months post-activation
  The impedance will be measured across the active electrodes of the implant for each participant.

Countries

Australia, France, Germany, United Kingdom