CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 51 enrolled
Drug / intervention
Osia 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.

Search/NCT03086135
NCT03086135N/ACompleted

Clinical Performance of a New Implant System for Bone Conduction Hearing

Cochlear·interventional·Posted Mar 22, 2017·Updated Oct 14, 2021

In Brief

A clinical study evaluating Osia System for Deafness; Sensoneural Single Sided and 2 related conditions. Completed, enrolled 51 participants across 5 sites in 5 countries.

Detailed Summary

To study the initial experience with implanting and fitting the new Bone conduction system in patients with conductive, mixed or Single sided Sensorineural deafness.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Germany, Netherlands, Poland, United States
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedMar 22, 2017
Enrollment StartMar 9, 2017
Primary CompletionOct 30, 2018
Study CompletionJun 20, 2019
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 9.3 years ago

Interventions

Osia Systemdevice

An external Sound Processor captures and digitize the sound which is transferred to the internal implant where it is converted to an electrical signal. The electrical signal is further transferred as a vibration through an osseointegrated implant to the mastoid bone and eventually to the cochlea.