NCT06459765

Mi2000 Totally Implantable Cochlear Implant (Mi2000 TICI)

Mi2000 Totally Implantable Cochlear Implant (Mi2000 TICI): Pivotal Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: MED-EL Elektromedizinische Geräte GesmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to test the Mi2000 Totally Implantable Cochlear Implant in a population of candidates for a cochlear implant. The main question it aims to answer is, whether the device is able to improve speech perception compared to the pre-operative score. Participants will undergo cochlear implantation and fitting, and will be asked to perform the following tests pre- and post-operatively: * Word test in quiet * Sentence test in noise * Audiograms * Health Utilities Index 2 and 3 (HUI2\&3), a generic quality-of-life questionnaire * Nijmengen Cochlear Implant Questionnaire (NCIQ), a disease specific quality-of life questionnaire * Speech, Spatial and Qualities of Hearing Scale (SSQ12), a disease specific questionnaire * Hearing Implant Sound Quality Index (HISQUI19), a sound quality questionnaire

Detailed description

Cochlear implants (CI) provide a large majority of recipients with a significant degree of speech understanding. However, CI systems rely on external audio processors to function. This can have several disadvantages: for instance, the hardware is exposed to external trauma and to the effects of head movement and gravity. The device is also put at risk by humid, dusty, or dirty conditions as well as by physical activities that lead to water exposure such as swimming or sports in general (e.g. perspiration). In addition, some patients are concerned with the cosmetic appearance of the external parts which are visible (more so than modern behind-the-ear hearing aids), something that may not be desirable to many potential candidates. This clinical investigation aims to collect confirmatory data on the use of the Mi2000 Totally Implantable Cochlear Implant system used in combination with compatible devices.

Conditions

• Hearing Loss, Sensorineural

Interventions

Type	Name	Description
DEVICE	Mi2000 TICI	Cochlear Implantation

Timeline

• Start date: 2024-06-07
• Primary completion: 2025-09-24
• Completion: 2025-09-24
• First posted: 2024-06-14
• Last updated: 2025-10-01

Locations

6 sites across 4 countries: Austria, Belgium, Germany, Poland