deltatrials
Terminated OBSERVATIONAL NCT04038216

Single-stage Surgery Using the BI300 Implant

Single-stage Bone-anchored Hearing Implant Surgery in the Pediatric Population Using the BI300 Implant

Sponsor: Cochlear Bone Anchored Solutions

Updated 9 times since 2019 Last updated: Nov 14, 2025 Started: Sep 1, 2019 Primary completion: Mar 25, 2025 Completion: Mar 25, 2025
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Due to lagging enrollment, partly because of the COVID-19 pandemic, we were overtaken by the favourable preliminary results of the single-stage group during the study period.

This observational or N/A phase trial investigates Hearing Impaired Children and Hearing Impairment, Conductive and is currently terminated or withdrawn. Cochlear Bone Anchored Solutions leads this study, which shows 9 recorded versions since 2019 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Aug 2019 – ~Sep 2019 · 31 days · monthly snapshotNot Yet Recruiting~Sep 2019 – ~Apr 2020 · 7 months · monthly snapshotNot Yet Recruiting~Apr 2020 – ~Jan 2021 · 9 months · monthly snapshotRecruiting~Jan 2021 – ~Mar 2022 · 14 months · monthly snapshotRecruiting~Mar 2022 – ~Nov 2023 · 20 months · monthly snapshotRecruiting~Nov 2023 – ~Jul 2024 · 8 months · monthly snapshotUnknown Status~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotUnknown~Sep 2024 – ~Dec 2025 · 15 months · monthly snapshotUnknown~Dec 2025 – present · 7 months · monthly snapshotTerminated

Change History

9 versions recorded
  1. Dec 2025 — Present [monthly]

    Terminated

    Status: UnknownTerminated

  2. Sep 2024 — Dec 2025 [monthly]

    Unknown

  3. Jul 2024 — Sep 2024 [monthly]

    Unknown

    Status: Unknown StatusUnknown

  4. Nov 2023 — Jul 2024 [monthly]

    Unknown Status

    Status: RecruitingUnknown Status

  5. Mar 2022 — Nov 2023 [monthly]

    Recruiting

Show 4 earlier versions
  1. Jan 2021 — Mar 2022 [monthly]

    Recruiting

  2. Apr 2020 — Jan 2021 [monthly]

    Recruiting

    Status: Not Yet RecruitingRecruiting

  3. Sep 2019 — Apr 2020 [monthly]

    Not Yet Recruiting

  4. Aug 2019 — Sep 2019 [monthly]

    Not Yet Recruiting

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Cochlear Bone Anchored Solutions
  • Radboud University Medical Center
Data source: Radboud University Medical Center

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations