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

NCT05058066 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2025-11-18

No results posted yet for this study

Summary

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

Conditions

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)

Sponsors & Collaborators

  • Cochlear Bone Anchored Solutions

    collaborator INDUSTRY

  • Radboud University Medical Center

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-24
Primary Completion
2020-09-21
Completion
2020-09-21

Countries

  • Netherlands

Study Locations

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Entities

Diseases

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 NCT05058066 on ClinicalTrials.gov