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Clinical Investigation Study of Safety and Performance of the Sentio System.
Sponsor: Oticon Medical
Summary
Prospective, open label, single-arm, multi-centre investigation, designed to follow clinical practice for Sentio bone conduction devices in 50 subjects, during 10 clinical visits, and 24 months follow-up.
Official title: A Prospective, Multi-center, Single-arm, Clinical Investigation of the Safety and Performance of the Sentio System in Users With Mixed/Conductive Hearing Losses and Single Sided Deafness
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
51
Start Date
2022-01-19
Completion Date
2025-11
Last Updated
2024-04-03
Healthy Volunteers
No
Interventions
Active transcutaneous bone conduction hearing system
The Sentio system consists of the Sentio 1 sound processor (SP) and Sentio Ti implant with fixation band and screws.
Locations (6)
Universitätsklinikum Freiburg Universitätsklinik für Hals,- Nasen und Ohrenheilkunde
Freiburg im Breisgau, Germany
HNO-Klinik Medizinische Hochschule Hanover
Hanover, Germany
ENT Department, University Medical Center Groningen
Groningen, Netherlands
ENT department Radboud University Medical Center (Radboud UMC)
Nijmegen, Netherlands
ENT - University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital Birmingham
Birmingham, United Kingdom
Cambridge University Hospitals NHS Foundation Trust, Addenbrookes Hospital
Cambridge, United Kingdom