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.

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NCT06844071

The Sentio System: Post-market Evaluation of Safety and Performance in Adolescents

Recruiting
Not specifiedAges 12–18Observational
Oticon Medical
~25 participants
Updated 2025-09-22 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
A. To demonstrate that the Sentio system improves hearing on the implanted ear.
Measured over 3months post implantation
Hearing Loss
1 sites across 1 states
Georgia1

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Eligibility criteria

Inclusion

Subjects must meet the following criteria to be eligible for participation in the investigation:

Exclusion

Subjects meeting any of the following criteria will not be permitted to participate in the investigation:
Defined as \>10 dB difference measured across PTA of .5, 1, 2, \& 3kHz
  • A. To demonstrate that the Sentio system improves hearing on the implanted ear.3months post implantation