CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 77 enrolled
Drug / intervention
Novel Implant BI300 +1 moredevice
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/NCT02092610
NCT02092610N/ACompleted
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Long Term Stability, Survival and Tolerability of a (Novel) Baha® Implant System

Cochlear Bone Anchored Solutions·interventional·Posted Mar 20, 2014·Updated Feb 15, 2016

In Brief

A clinical study evaluating Novel Implant BI300 and Standard Implant BI300 for Conductive Hearing Loss. Completed, enrolled 77 participants across 4 sites in 3 countries.

Detailed Summary

An international multicentre, open, comparative, parallel group, prospective clinical investigation with a single 5 year follow up visit.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsConductive Hearing Loss
CountriesNetherlands, Sweden, United Kingdom
Collaborators--

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMar 20, 2014
Enrollment StartMay 1, 2014
Primary CompletionMar 1, 2015
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 12.3 years ago

Interventions

Novel Implant BI300device

The Novel Implant BI300 was the new titanium implant and abutment for the Baha system developed by Cochlear Bone Anchored Solutions AB. The novel implant is 4.5 mm wide and 4.0 mm long.

Standard Implant BI300device

The Standard Implant BI300 was the standard titanium implant and abutment in the Baha system developed by Cochlear Bone Anchored Solutions AB. The implant is 3.75 mm wide and 4.0 mm long