Un Estudio Pivotal para Evaluar los Beneficios Clínicos, el Rendimiento y la Seguridad de un Sistema de Implante Coclear Totalmente Implantable (TICI) en Adultos

Resumen breve

This pivotal study examines the clinical efficacy and safety of an investigational totally implantable cochlear implant (TICI) system. The system includes a microphone placed under the skin to detect speech and sound from the environment, providing the option to hear without any visible external parts. This study will involve adults with sensorineural hearing loss, a type of hearing loss caused by damage to the inner ear or auditory nerve (the nerve that carries sound signals from the ear to the brain). Participants will complete hearing tests and questionnaires to evaluate how well the system works and how it affects their daily life.