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Long Term Stability, Survival and Tolerability of a (Novel) Baha® Implant System

NCT02092610 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2016-02-15

Study results available
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Summary

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

Conditions

  • Conductive Hearing Loss

Interventions

DEVICE

Novel Implant BI300

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.

DEVICE

Standard Implant BI300

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

Sponsors & Collaborators

  • Cochlear Bone Anchored Solutions

    lead INDUSTRY

Principal Investigators

  • Johan Blechert, M.Sc · Cochlear Bone Anchored Solutions AB

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2015-03-31
Completion
2015-03-31

Countries

  • Netherlands
  • Sweden
  • United Kingdom

Study Locations

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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 NCT02092610 on ClinicalTrials.gov