# Single-stage Surgery Using the BI300 Implant

> **NCT04038216** · — · TERMINATED · sponsor: **Radboud University Medical Center** · enrollment: 70 (actual)

## Conditions studied

- Hearing Impaired Children
- Hearing Impairment, Conductive

## Interventions

- **PROCEDURE:** Single-stage surgery
- **OTHER:** Two-stage surgery

## Key facts

- **NCT ID:** NCT04038216
- **Lead sponsor:** Radboud University Medical Center
- **Sponsor class:** OTHER
- **Phase:** —
- **Study type:** OBSERVATIONAL
- **Status:** TERMINATED
- **Start date:** 2019-09-01
- **Primary completion:** 2025-03-25
- **Final completion:** 2025-03-25
- **Target enrollment:** 70 (ACTUAL)
- **Why stopped:** 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.
- **Last updated:** 2025-11-18

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04038216

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04038216, "Single-stage Surgery Using the BI300 Implant". Retrieved via AI Analytics 2026-06-01 from https://api.ai-analytics.org/clinical/NCT04038216. Licensed CC0.

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