Status:
COMPLETED
Long Term Clinical Investigation to Evaluate Clinical Performance, Safety and Patient Reported Outcomes of an Active Osseointegrated Steady-State Implant System
Lead Sponsor:
Cochlear
Collaborating Sponsors:
Statistiska Konsultgruppen
Conditions:
Hearing Loss
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 clin...
Eligibility Criteria
Inclusion
- Subject has performed Hearing assessment at 3 and/or 6 months in the clinical investigation CBAS5751
- Willing and able to provide written informed consent
Exclusion
- Unable to follow investigational procedures, e.g. to complete quality of life scales, or unwilling to comply with the requirements of the clinical investigation as determined by the investigator
- Use of ototoxic drugs that could be harmful to the hearing, as judged by the investigator
Key Trial Info
Start Date :
May 6 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 21 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04754477
Start Date
May 6 2021
End Date
March 21 2022
Last Update
June 10 2024
Active Locations (3)
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1
SCIC / NextSense
Gladesville, New South Wales, Australia, 2111
2
HEARnet Clinical studies
Carlton, Victoria, Australia, 3053
3
Department of Otorhinolaryngology, Head and Neck Surgery Faculty of Medicine. The Chinese University of Hong Kong
Hong Kong, Hong Kong