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Stability of the Cochlear Baha BI300/BA400 Implant System Loaded From 1 Week Post-surgery

NCT02096809 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2015-12-08

No results posted yet for this study

Summary

Objectives

* To evaluate the safety of processor loading of the Cochlear BI300/BA400 implant system 1 week after implantation
* To evaluate the short term soft tissue healing and the long term skin reaction, with the new Cochlear BI300/BA400 implant system using the linear incision without subcutaneous tissue reduction.
* To produce reference data regarding the stability of the BI300/BA400 implant system.

Study design: Prospective cohort study. Patients: 24 adults with anticipated normal skin and bone quality eligible for bone anchored implant surgery.

Intervention: Loading of the sound processor one week after surgery Main outcome measures: Implant stability, soft tissue reaction, skin overgrowth, pain and numbness will be assessed.

It is hypothesized that implant loading can be performed one week after surgery without any changes in implant stability, soft tissue reaction, skin overgrowth, pain or numbness around implant.

Conditions

  • Hearing Loss - Conductive

Interventions

PROCEDURE

One week loading of Bone Anchored Hearing Aid (BAHA)

Patients in this arm will be fitted with the BAHA one week after surgery.

DEVICE

Cochlear Baha BI300/BA400 Implant System

Sponsors & Collaborators

  • Aarhus University Hospital

    lead OTHER

Principal Investigators

  • Lars V Johansen, D.MSc. · Aarhus University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2014-08-31
Completion
2015-09-30

Countries

  • Denmark

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 NCT02096809 on ClinicalTrials.gov