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NCT03859648 · ClinicalTrials.gov registry record · NA

BONEBRIDGE Bone Conduction Implant in Adults

A NA study, sponsored by Med-El Corporation.

Terminated
Registry status
NA
Development phase
9
Enrollment target

NCT03859648: Clinical Trial NA study, sponsored by Med-El Corporation.

NCT03859648 is a NA study that was terminated before completion, run by Med-El Corporation. The registered enrollment target is 9 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03859648, a NA study, was terminated before completion, sponsored by Med-El Corporation.

TERMINATED
Registry status
NA
Development phase
9 participants
Enrollment target

Study Summary

Approximately thirty subjects with mixed or conductive hearing loss, meeting FDA-cleared candidacy criteria for the BONEBRIDGE, will be implanted and followed for three (3) months post-activation to assess safety and effectiveness of the BONEBRIDGE implant.

Primary Outcome

Adverse events will be collected and reported throughout the duration of the study.

Interventions

  • DEVICE BONEBRIDGE

Trial Details

FieldValue
Enrollment Target 9 participants
Start Date 2019-08-26
Est. Completion 2022-11-04
Phase NA
Med-El Corporation

14 total trials

Why NCT03859648 stopped before completion

NCT03859648 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 1 intervention - of which BONEBRIDGE is the first listed.

NCT03859648 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03859648 about?

NCT03859648 is a clinical study titled "BONEBRIDGE Bone Conduction Implant in Adults". Approximately thirty subjects with mixed or conductive hearing loss, meeting FDA-cleared candidacy criteria for the BONEBRIDGE, will be implanted and followed for three (3) months post-activation to assess safety and effectiveness of the BONEBRIDGE implant.

What is the current status of trial NCT03859648?

This trial is currently terminated. It is a NA study. The enrollment target is 9 participants. The study started on 2019-08-26. Estimated completion is 2022-11-04.

What interventions are being tested in trial NCT03859648?

The interventions under investigation include: BONEBRIDGE (DEVICE).

Who is sponsoring clinical trial NCT03859648?

This trial is sponsored by Med-El Corporation, which has 14 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03859648's enrollment target sits among peer trials

9 1975th of 2000 higher than 25 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03859648, the US trial registry maintained by the National Library of Medicine. NCT03859648 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.