10-year Follow-up of a Wide Diameter Bone Anchored Hearing Implant

NACompletedINTERVENTIONAL
Enrollment

51

Participants

Timeline

Start Date

June 24, 2019

Primary Completion Date

September 21, 2020

Study Completion Date

September 21, 2020

Conditions
Hearing Loss
Interventions
DEVICE

Baha® flange fixture (diameter 3.75mm; length 4mm) with 6mm abutment

The control implant included the previous generation as-machined titanium Baha® flange fixture (diameter 3.75mm; length 4mm) with 6mm conically shaped abutment.

DEVICE

Baha® BIA300 Implant (diameter 4.5mm; length 4mm) with 6mm abutment

The test implant and the implant used for the 3-week loading trial included the wide diameter titanium implant (diameter 4.5mm; length 4mm) with 6mm rounded, apically converging titanium abutment developed by Cochlear Bone Anchored Solutions AB (Mölnlyncke, Sweden). This system with an additional minor change to the internal abutment connection design was later commercialized under the name Cochlear™ Baha® BIA300 Implant with abutment. In addition to the difference in abutment shape and the wider diameter, the test implant incorporates small-sized threads at the implant neck and the moderately rough TiOblast™ (Dentsply, Mölndal, Sweden) surface on the intraosseous part of the implant6-8.

PROCEDURE

Early loading

Loading the implant at 3 weeks after implantation (instead of 6 weeks after implantation)

Trial Locations (1)

6525EX

Radboudumc, Nijmegen

Sponsors
All Listed Sponsors
collaborator

Cochlear Bone Anchored Solutions

INDUSTRY

lead

Radboud University Medical Center

OTHER

NCT05058066 - 10-year Follow-up of a Wide Diameter Bone Anchored Hearing Implant | Biotech Hunter | Biotech Hunter