Clinical and Health Economic Evaluation With a New Baha® Abutment Combined With a Minimally Invasive Surgical Technique

NACompletedINTERVENTIONAL
Enrollment

106

Participants

Timeline

Start Date

February 28, 2013

Primary Completion Date

June 30, 2015

Study Completion Date

November 30, 2017

Conditions
DeafnessHearing LossHearing Loss, ConductiveHearing Loss, Mixed Conductive-Sensorineural
Interventions
DEVICE

Minimally invasive surgery and BA400

The Cochlear Baha BA400 Abutment has been designed with a concave shape at the lower aspect of the abutment. The abutment is made of commercially pure titanium and is coated with a hydroxyapatite layer on the entire soft tissue-contacting surface of the abutment up to 3 mm below the top surface (2 mm below the top surface on 6 mm abutments).

DEVICE

Traditional surgery and BA300

The BA300 abutment is made of commercially pure titanium and is available in two different lengths (6 mm and 9 mm).

Trial Locations (7)

5623

Dept. ENT/KNO, Eindhoven

6202

NT department, Maastricht

31059

Service ORL, Toulouse

Unknown

KNO arts, Amphia Ziekenhuis, Breda

Deventer Ziekenhuis, Deventer

ES-46010

Otorhinolaryngology, Hospital Clinico Universitario De Valencia, Valencia

411 35

ENT Clinic, Gothenburg

All Listed Sponsors
lead

Cochlear Bone Anchored Solutions

INDUSTRY

NCT01796236 - Clinical and Health Economic Evaluation With a New Baha® Abutment Combined With a Minimally Invasive Surgical Technique | Biotech Hunter | Biotech Hunter