NCT03859648

BONEBRIDGE Bone Conduction Implant in Adults

Terminated NA Results posted Last updated 30 May 2024

What this trial tests

NA trial testing BONEBRIDGE in Hearing Loss, Conductive in 9 participants. Terminated before completion.

Timeline

26 August 2019

Primary endpoint
4 November 2022

4 November 2022

Quick facts

Lead sponsor	Med-El Corporation
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	9
Start date	26 August 2019
Primary completion	4 November 2022
Estimated completion	4 November 2022
Sites	3 locations across Canada, United States

Drugs / interventions tested

• BONEBRIDGE

Conditions studied

• Hearing Loss, Conductive — all drugs for Hearing Loss, Conductive →
• Hearing Loss, Mixed — all drugs for Hearing Loss, Mixed →

Sponsor

Med-El Corporation — full company profile →

Who can join

18 and older, any sex, with Hearing Loss, Conductive or Hearing Loss, Mixed. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number and Proportion of Subjects Experiencing Device Related Adverse Events Primary · Up to three (3 months) post activation

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

Group	Value	95% CI
BONEBRIDGE	1

Percentage Change in AZ Bio Sentence Score in Noise Primary · Baseline and 3 months post activation

Percent improvement in AZ Bio sentence in noise scores will be compared from baseline to 3 months post activation.

Group	Value	95% CI
BONEBRIDGE	42.2	23 – 95

Percentage Change in CNC Word Score Secondary · Baseline and 3 months post activation

Percent improvement in CNC word scores will be compared from baseline to 3 months post activation.

Group	Value	95% CI
BONEBRIDGE	38.3	23 – 70

Number of Subjects With Stable or Better Soundfield Thresholds Secondary · Baseline and 3 months post activation

The number of subjects with stable or better aided soundfield thresholds at 3 months post activation compared to baseline unaided soundfield thresholds

Group	Value	95% CI
BONEBRIDGE	5

Number of Subjects With Better QuickSIN Signal-to-noise-ratio Performance Secondary · Baseline and 3 months post activation

The number of subjects with similar or better performance on the QuickSIN (Speech In Noise) task in the implanted ear compared to baseline performance

Group	Value	95% CI
BONEBRIDGE	6

Number of Subjects With Stable Unaided Bone Conduction Thresholds Secondary · Baseline and 2 weeks post surgery

The number of subjects with stable bone conduction thresholds at the device activation interval compared to pre-operative bone conduction thresholds.

Group	Value	95% CI
BONEBRIDGE	7

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected from surgery through 3 months post-activation.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

BONEBRIDGE

Serious: 1/8 (13%)

Deaths: 0/8

Serious adverse events (1 terms)

Reaction	System	BONEBRIDGE
Postoperative infection	Infections and infestations	—

Other adverse events (1 terms — click to expand)

Reaction	System	BONEBRIDGE
Scalp sensitivity	Skin and subcutaneous tissue disorders	—

Most-reported serious reactions: Postoperative infection.

Data from ClinicalTrials.gov NCT03859648 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.