Pediatric Expansion Study of the Sentio System

Summary

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.

Conditions

• Hearing Loss, Conductive
• Hearing Loss, Mixed
• Single Sided Deafness

Interventions

DEVICE

Active transcutaneous bone conduction system

The Sentio system consists of the Sentio 1 Mini sound processor (SP) and Sentio Ti implant with fixation band and screws.

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust

  collaborator OTHER

• Birmingham Women's and Children's NHS Foundation Trust

  collaborator OTHER

• Great Ormond Street Hospital for Children NHS Foundation Trust

  collaborator OTHER

• University Medical Center Groningen

  collaborator OTHER

• Radboud University Medical Center

  collaborator OTHER

• Hospital Universitario La Fe

  collaborator OTHER

• Hospital Universitario Virgen Macarena

  collaborator OTHER

• Hospital Donostia

  collaborator OTHER

• Oticon Medical

  lead INDUSTRY

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

3 Years

Max Age

11 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-04-30

Primary Completion

2026-10-01

Completion

2027-07-01

Countries

• Netherlands
• Spain
• United Kingdom

Study Locations