Details checkedClinical trial listing onlyHistorical/discontinuedCheckedregistry

Radboud BI300 single-stage pediatric BAHI surgery study

Also known as: Single-stage Surgery Using the BI300 Implant, BI300 Implant, BA300 abutment, Two-stage surgery, 2019-5407, NCT04038216

Institution-led study

Primary source

Sponsor / Institution

Institution-led study

Program Type

Procedure/Rehab

Modality

Procedure/Rehab

Stage

Observational/NA

Status

Discontinued

Target Gene

—

Route / Mode

Bone-anchored hearing implant surgery

Confidence

82%

Status Confidence

Status needs checking

Evidence Strength

Needs more support

Last Reviewed

2026-06-09

Geography

Netherlands

Population

pediatric, conductive-hearing-loss, bone-anchored-hearing-implant, surgery

Trial IDs

Mechanism

Prospective comparison of single-stage versus historical two-stage bone-anchored hearing implant surgery in children using the BI300 implant and BA300 abutment.

Indications

Hearing Loss Conductive Hearing Loss

Notes

Split from the generic Two-Stage Surgery record. ClinicalTrials.gov lists Radboud University Medical Center as lead sponsor and Cochlear Bone Anchored Solutions as collaborator. Status is normalized to Discontinued because the registry status is Terminated due to lagging enrollment and emerging favorable preliminary single-stage results.

Evidence & Sources

1 structured sources

clinicaltrials

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IDs: NCT04038216, 2019-5407

Open

Key Events

2019-09-01

Radboud BI300 pediatric BAHI surgery study started

2025-03-25

ClinicalTrials.gov lists the BI300 study as terminated

Clinical Trials (1)