At a glance
ClinicalIndex Comparison RecordN/ACompleted· 29 enrolled
Drug / intervention
Osia 2 systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective, Multicentre, Open Clinical Investigation Evaluating Clinical Performance, Safety and Patient Reported Outcomes With an Active Osseointegrated Steady-State Implant System (OSI) in Adult Subjects With Conductive Hearing Loss, Mixed Hearing Loss or Single-sided Sensorineural Deafness
In Brief
A clinical study evaluating Osia 2 system for Hearing Loss. Completed, enrolled 29 participants across 3 sites in 2 countries.
Detailed Summary
The aim of this clinical investigation is to collect data on objective and subjective hearing performance, quality of life and safety in adult subjects with conductive hearing loss, mixed hearing loss or single-sided sensorineural deafness.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHearing Loss
CountriesAustralia, Hong Kong
CollaboratorsStatistiska Konsultgruppen
Timeline
N/ACompletedFinished
2020202120222023202420252026
First PostedAug 2019
Enrollment StartAug 2019
Primary CompletionJun 2020
Study CompletionSep 2020
TodayJul 2026
First PostedAug 1, 2019
Enrollment StartAug 16, 2019
Primary CompletionJun 19, 2020
Study CompletionSep 24, 2020
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 6.9 years ago
Interventions
Osia 2 systemdevice
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.