MedTrace Logo

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

NCT04754477 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-06-10

Study results available
· View outcomes & findings →

Summary

The aim of this clinical investigation is to collect long-term safety and performance data with the Active Osseointegrated Steady-State Implant System by following subjects from the previous Osia clinical investigation CBAS5751. In addition, questions regarding device satisfaction, sound satisfaction, usability and health care utilisation will be asked.

Conditions

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

Sponsors & Collaborators

  • Statistiska Konsultgruppen

    collaborator OTHER

  • Cochlear

    lead INDUSTRY

Principal Investigators

  • Karin Ganlöv, MD · Cochlear

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-06
Primary Completion
2022-03-21
Completion
2022-03-21

Countries

  • Australia
  • Hong Kong

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04754477 on ClinicalTrials.gov