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.
The investigation is a 24-months multinational, multicentre, prospective, open label, single arm investigation on the Sentio system. The purpose of this investigation is to evaluate safety and performance three months after implantation of the new Sentio system. In addition, safety will be analysed six months after implantation, and long-term safety and performance will be evaluated over a 24-month follow-up period. The endpoints chosen, together with applicable measurements, are commonly used, both in the clinical setting as well as in bone anchored hearing research as shown in the scientific literature covering this area. That is, the primary objectives of this study is to demonstrate that the Sentio system improves hearing and speech recognition on the implanted ear. Secondary objectives includes investigation of hearing improvement, speech intelligibility, patient satisfaction, and quality of life. The study also aims to evaluate the safety profile of the Sentio system in terms of the occurrence of adverse events and serious adverse events related to the device.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
51
The Sentio system consists of the Sentio 1 sound processor (SP) and Sentio Ti implant with fixation band and screws.
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)
Demonstrate that the Sentio system improves hearing on the implanted ear.
Functional gain with Sentio, i.e. the difference between preoperative unaided and aided sound field thresholds on the implanted ear.
Time frame: 3 months post-surgery
Demonstrate that the Sentio system provides patients with improved speech recognition on the implanted ear.
Difference in speech recognition score in percent between pre-operative unaided condition and aided with Sentio, measured in quiet on the implanted ear.
Time frame: 3 months post-surgery
Thorough assessment of performance (functional gain, effective gain, speech recognition), satisfaction, usability, comfort and health-related quality of life.
Sound field audiometry, speech testing in quiet and noise and patient reported outcomes on listed topics.
Time frame: 3-24 months post-surgery
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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