NCT05058066

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

Long-term Follow-up of a Wide Diameter Bone Anchored Hearing Implant: the 10-year Experience on Stability, Survival and Tolerability of the BIA300®

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A single centre, open, comparative, parallel group, prospective clinical investigation with a single 10 year follow up visit.

Detailed description

This study is a continuation of two previous conducted trials: 1. Stability, long term survival and tolerability of a novel Baha® implant system, a multi-centre investigation new BIA300 (test) implant vs previous generation (control) implant: 1. CAG5173: 6-month(1) and 3-year(2) data. 2. CBAS5562: 5-year data(3). 2. 3 weeks loading: stability, long term survival and tolerability of a novel Baha® implant system, a multi-centre investigation 3 week loading vs 6+ week loading (= same group as control group trial 1). 6- month(4) and 3-year(5) data. In this study the (5-year data for trial 2 and) 10-year data regarding stability, survival and soft tissue tolerability from the above mentioned trials will be evaluated and compared. The previous trials were multicentre, but the current study will be single-centred and therefore only include the participants of the Radboud site. Data will be collected at a visit at (5 years, for trial 2 and) 10 years (+/- 6 months) after implantation. Up to now, no RCT of these implants (with the loading of 3 weeks after implantation) has assessed stability, survival and tolerability over a 10-year follow-up period.

Conditions

• Hearing Loss

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2019-06-24
• Primary completion: 2020-09-21
• Completion: 2020-09-21
• First posted: 2021-09-27
• Last updated: 2025-11-18

Locations

1 site across 1 country: Netherlands