MedTrace Logo

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

NCT05166265 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2024-04-03

No results posted yet for this study

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.

Conditions

  • Hearing Loss, Conductive
  • Hearing Loss, Mixed
  • Hearing Loss, Unilateral

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.

Sponsors & Collaborators

  • Oticon Medical

    lead INDUSTRY

Principal Investigators

  • Myrthe Hol, MD, PhD · ENT Department, University Medical Center Groningen

  • Emmanuel Mylanus, MD, PhD · ENT Department, Radboud University Medical Center

  • Peter Monksfield, MD, PhD · ENT - University Hospitals Birmingham NHS, Foundation Trust

  • James Tysome, MD, PhD · Cambridge University Hospitals NHS Foundation Trust, Addenbrookes Hospital

  • Susan Arndt, MD, PhD · Universitätsklinikum Freiburg

  • Thomas Lenartz, MD, PhD · HNO-Klinik Medizinische Hochschule Hannover

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-19
Primary Completion
2024-02-19
Completion
2025-11-30

Countries

  • Germany
  • Netherlands
  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05166265 on ClinicalTrials.gov