Clinical Performance, Safety and Patient Reported Outcomes of an Active Osseointegrated Steady-State Implant System

NACompletedINTERVENTIONAL
Enrollment

29

Participants

Timeline

Start Date

August 16, 2019

Primary Completion Date

June 19, 2020

Study Completion Date

September 24, 2020

Conditions
Hearing Loss
Interventions
DEVICE

Osia 2 system

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 processor.

Trial Locations (3)

Unknown

Sydney Cochlear Implant Centre, Gladesville

The Royal Victorian Eye and Ear Hospital, Melbourne

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

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Statistiska Konsultgruppen

OTHER

lead

Cochlear

INDUSTRY

NCT04041700 - Clinical Performance, Safety and Patient Reported Outcomes of an Active Osseointegrated Steady-State Implant System | Biotech Hunter | Biotech Hunter