Pediatric Expansion Study of the Sentio System

NARecruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

April 30, 2025

Primary Completion Date

October 1, 2026

Study Completion Date

July 1, 2027

Conditions
Hearing Loss, ConductiveHearing Loss, MixedSingle 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.

Trial Locations (8)

20014

RECRUITING

Hospital Universitario de Donostia, San Sebastián

41009

RECRUITING

Hospital Universitario Virgen Macarena, Seville

46026

RECRUITING

Hospital Universitario y Politécnico La Fe, Valencia

9700 RB

RECRUITING

University Medical Center Groningen, Groningen

6525EX

RECRUITING

Radboud University Medical Center, Nijmegen

B4 6NH

NOT_YET_RECRUITING

Birmingham Children's hospital, Birmingham Women's and Children's NHS Foundation Trust, Birmingham

SE1 7EH

RECRUITING

The Evelina London Children's Hospital, Guy's and St Thomas' NHS Foundation Trust, London

WC1N 3JH

RECRUITING

Great Ormond Street Hospital, Great Ormond Street Hospital for Children NHS Foundation Trust, London

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Guy's and St Thomas' NHS Foundation Trust

OTHER

collaborator

Birmingham Women's and Children's NHS Foundation Trust

OTHER

collaborator

Great Ormond Street Hospital for Children NHS Foundation Trust

OTHER

collaborator

University Medical Center Groningen

OTHER

collaborator

Radboud University Medical Center

OTHER

collaborator

Hospital Universitario La Fe

OTHER

collaborator

Hospital Universitario Virgen Macarena

OTHER

collaborator

Hospital Donostia

OTHER

lead

Oticon Medical

INDUSTRY

NCT06976086 - Pediatric Expansion Study of the Sentio System | Biotech Hunter | Biotech Hunter