Pediatric Expansion Study of the Sentio System
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-11
SponsorOticon Medical
About this trial
This study is performed to collect safety and performance data supporting the use of the Sentio system in children below 12 years of age. The system is currently available on the market for patients 12 years and above. It is a prospective study conducted at eight European hospitals, aiming to treat 50 patients with a hearing loss than would benefit from treatment with a bone-anchored hearing system (BAHS). The primary objective of the study is to demonstrate that the Sentio system improves the hearing on the implanted ear, compared with the unaided situation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Signed Informed Consent Form (depending on age of child, signed by parent or legal guardian and child)
Subject aged 3 to 11 years
Subject and parent or legal guardian have the ability and willingness to comply with investigational procedures/ requirements, as determined by the investigator.
Subject with prior experience of amplified sound through a properly fitted hearing aid, a CROS device, or a non-surgical bone anchored solution (e.g. softband).
Disqualifiers
Medical condition that contraindicates implant surgery or anesthesia as judged by the investigator.
Untreated ongoing middle ear infection at the time of surgery.
Known or suspected contact allergy to silicone or other material used in the Sentio system.
Known condition that could jeopardize wound healing and skin condition, e.g. uncontrolled diabetes over time, as judged by the investigator.
Trial design
Design model
Single group
Treatments tested in this trial
Active transcutaneous bone conduction system
DeviceThe Sentio system consists of the Sentio 1 Mini sound processor (SP) and Sentio Ti implant with fixation band and screws.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Sentio systemExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Demonstrate that the Sentio system improves hearing on the implanted ear.
Functional gain with the Sentio system, i.e. the difference between pre-operative unaided and post-operative aided sound field thresholds on the implanted ear. The functional gain is calculated as the average of frequencies 500, 1000, 2000 and 4000 Hz (PTA4).
Time frame
3 months post-surgerySecondary outcomes
1
Evaluation of the safety profile of the Sentio system in terms of the occurrence of adverse events and serious adverse events related to the device.
Tabulated adverse events and serious adverse events related to the device reported from surgery throughout the investigation reported at 3 months post-surgery.
Time frame
3 months post-surgery2
Functional gain
Functional gain is used to assess the performance of the Sentio system. The functional gain is a calculation and is defined as the difference between unaided and aided sound field thresholds. The average functional gain is calculated as the average of frequencies 500, 1000, 2000 and 4000 Hz (PTA4).
Time frame
12 months post-surgery3
Effective gain
Effective gain is used to assess the degree the Sentio system compensates for the hearing loss on the implanted ear in patients with mixed/conductive hearing losses. Effective gain is a calculation and is defined as the aided threshold relative to the BC (unmasked bone conduction) threshold and is calculated as the difference in dB between aided sound field thresholds and BC in situ hearing thresholds. The average effective gain (PTA4) is calculated as the average of frequencies 500, 1000, 2000 and 4000 Hz.
Time frame
12 months post-surgery4
Assessment of speech recognition improvement
Difference in speech recognition score (%) between pre-operative unaided condition and Sentio-aided condition, measured in quiet on the implanted ear.
Time frame
3 months post-surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Oticon Medical
Lead sponsor
Guy's and St Thomas' NHS Foundation Trust
Collaborator
Birmingham Women's and Children's NHS Foundation Trust
Collaborator
Great Ormond Street Hospital for Children NHS Foundation Trust
Collaborator
University Medical Center Groningen
Collaborator
Radboud University Medical Center
Collaborator
Hospital Universitario La Fe
Collaborator
Hospital Universitario Virgen Macarena
Collaborator
Hospital Donostia
Collaborator
Source ClinicalTrials.gov