Post-market Evaluation of the Sentio System for Hearing Loss in Adolescents
This study is looking at the Sentio system, a device for hearing loss, in adolescents aged 12 to 17 years. The main goal is to see if the Sentio system improves hearing in the implanted ear. Researchers will measure this improvement 3 months after the device is implanted. This is a post-market study, meaning the device is already available, and the study aims to collect more information on its safety and how well it works in real-world use for this age group. To join, you must be between 12 and 17 years old and meet specific hearing criteria for the device. The study plans to enroll 25 participants.
- Study design
- This is an observational study, meaning researchers will collect information without giving specific treatments. It is a single-arm study, so all participants will receive the Sentio system. The study plans to enroll 25 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Hearing improvement will be measured 3 months after implantation of the Sentio system.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
The Sentio System: Post-market Evaluation of Safety and Performance in Adolescents
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- A. To demonstrate that the Sentio system improves hearing on the implanted ear.3months post implantation