Exam Preview for 39935: Clinical Development of Sentio

Clinical Development of Sentio - Then, Now, and Future

Please note: exam questions are subject to change.

1. Which of the following is NOT a phase in the clinical development of Sentio? Pre-clinical Pilot Pivotal Commercialization
2. What is the primary goal of the Pilot phase in Sentio's development? To obtain regulatory approval To assess long-term safety and efficacy To evaluate early safety and performance To confirm safety and efficacy
3. Based on the data presented, what is the approximate percentage of patients who reported being "satisfied" or "very satisfied" with the Sentio sound processor? 50% 75% 92% 98%
4. What was the primary outcome measure in the Ghoncheh et al. 2022 study comparing Sentio and Ponto devices? Patient satisfaction Vibration of the cochlear promontory Implantation time Cost-effectiveness
5. According to the NCT05166265 pivotal study, which of the following statements is true about Sentio? t showed no improvement in speech recognition in noise. Patients reported a significant decline in quality of life. There was a significant improvement in aided thresholds compared to unaided. The device caused frequent discomfort for patients.