NCT04754477View on ClinicalTrials.gov

Long Term Clinical Investigation to Evaluate Clinical Performance, Safety and Patient Reported Outcomes of an Active Osseointegrated Steady-State Implant System

NACompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

May 6, 2021

Primary Completion Date

March 21, 2022

Study Completion Date

March 21, 2022

Conditions
Hearing Loss
Interventions
DEVICE

Active Osseointegrated Steady-State Implant System (OSI)

System includes the OSI200 implant surgically placed under the skin behind the ear, the BI300 implant osseointegrated in the bone and the external Osia 2 sound process

Trial Locations (3)

2111

SCIC / NextSense, Gladesville

3053

HEARnet Clinical studies, Carlton

Unknown

Department of Otorhinolaryngology, Head and Neck Surgery Faculty of Medicine. The Chinese University of Hong Kong, Hong Kong

Sponsors

Lead Sponsor

Cochlear
All Listed Sponsors
collaborator

Statistiska Konsultgruppen

OTHER

lead

Cochlear

INDUSTRY

NCT04754477 - Long Term Clinical Investigation to Evaluate Clinical Performance, Safety and Patient Reported Outcomes of an Active Osseointegrated Steady-State Implant System | Biotech Hunter | Biotech Hunter