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Single-stage Surgery Using the BI300 Implant

NCT04038216 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 70

Last updated 2025-11-18

No results posted yet for this study

Summary

Over the last few decades, the classical two-stage surgical procedure for inserting bone-anchored hearing implants (BAHIs) has been modified in adults into a single-stage procedure. This approach has several advantages since it avoids a second surgical procedure. The single-stage approach is proven to be safe and feasible in adults and is nowadays referred to as the standard surgical technique in adults. Despite favorable outcomes and advantages of the single-stage surgery, most Ear Nose Throat (ENT)-surgeons still perform two-stage surgery when inserting BAHI in the pediatric population. Therefore, the aim of this study is to compare implant loss between single-stage BAHI surgery and two-stage BAHI surgery in children aged 4 to 9 years.

Conditions

  • Hearing Impaired Children
  • Hearing Impairment, Conductive

Interventions

PROCEDURE

Single-stage surgery

the bone-anchored hearing implant will be inserted in one surgery

OTHER

Two-stage surgery

Two-stage surgery has already been performed, data will therefore be retrospectively collected

Sponsors & Collaborators

  • Cochlear Bone Anchored Solutions

    collaborator INDUSTRY

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Hol, dr · Radboud University Medical Center

Eligibility

Min Age
4 Years
Max Age
9 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2025-03-25
Completion
2025-03-25

Countries

  • Netherlands

Study Locations

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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 NCT04038216 on ClinicalTrials.gov