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ACTIVE NOT RECRUITING
NCT05166265
NA

Clinical Investigation Study of Safety and Performance of the Sentio System.

Sponsor: Oticon Medical

View on ClinicalTrials.gov

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

DEVICE

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