BONEBRIDGE Bone Conduction Implant in Adults

March 15, 2023 updated by: Med-El Corporation

Outcomes in Adults With Mixed or Conductive Hearing Loss Implanted With the BONEBRIDGE

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • London Health Sciences Centre
  • United States
    • Ohio
      • Columbus, Ohio, United States, 43081
        • The Ohio State Wexner Medical Center University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • The Hospital of the University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults, 18 years of age or older at the time of implantation
  • Conductive or mixed hearing loss, defined as:
  • Conductive hearing loss with pure-tone average (PTA) for bone conduction thresholds better than or equal to 25 dB at 500, 1000, 2000 and 3000 Hz
  • Mixed hearing loss with PTA for bone conduction thresholds better than or equal to 45dB at 500, 1000, 2000, and 3000 Hz
  • Air-bone gap greater than or equal to 30 dB at 500, 1000, 2000, and 3000 Hz
  • Ability to benefit from amplification as defined by a monosyllabic (CNC) word score of 30% correct or better
  • Bilateral BONEBRIDGE can be considered if the difference in PTA for bone conduction thresholds is 10 dB or less between the right and left ears
  • Prior experience with acoustic or bone conduction hearing aids, unless candidate is unable to wear amplification for medical reasons
  • Able to complete testing materials in English
  • CT scan indicating the patient's anatomy is adequate to enable placement of the implant
  • Ability to undergo general anesthesia
  • Appropriate motivation and expectation levels
  • Stated willingness to comply with all study procedures for the duration of the study

Exclusion Criteria:

  • Evidence that hearing loss is retrocochlear in origin
  • Skin or scalp condition precluding use of external audio processor
  • Suspected cognitive impairment or organic brain dysfunction

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bone Conduction Implant
All subjects will be implanted with the bone conduction implant.
Device: BONEBRIDGE
Bone Conduction Implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number and proportion of subjects experiencing device related adverse events
Time Frame: Up to three (3 months) post activation
Adverse events will be collected and reported throughout the duration of the study.
Up to three (3 months) post activation
Percent correct of words identified for sentences in noise in implanted ear
Time Frame: Up to three (3 months) post activation
AZBio sentence test recognition in noise scores will be calculated as percent correct of words in each sentence at unaided pre-operative performance through 3 months and reported as percentage points improved.
Up to three (3 months) post activation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent correct words recognition in quiet in implanted ear.
Time Frame: Up to three (3 months) post activation
CNC (Consonant Nucleus Consonant) words scores will be calculated as percent correct at unaided preoperative performance through 3 months and reported as percentage points improved.
Up to three (3 months) post activation
Unaided soundfield thresholds
Time Frame: Up to three (3 months) post activation
Subjects will demonstrate similar or better soundfield thresholds in the implanted ear compared to preoperative performance
Up to three (3 months) post activation
Signal to noise ratio in the implanted ear
Time Frame: Up to three (3 months) post activation
Subjects will demonstrate similar or better performance on the QuickSIN (Speech In Noise) in the implanted ear compared to preoperative performance.
Up to three (3 months) post activation
Unaided bone conduction thresholds
Time Frame: Up to two (2 weeks) post operative evaluation
Subjects will demonstrate stable bone conduction thresholds at the device activation interval compared to pre-operative bone conduction thresholds.
Up to two (2 weeks) post operative evaluation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Med-El Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 26, 2019

Primary Completion (Actual)

November 4, 2022

Study Completion (Actual)

November 4, 2022

Study Registration Dates

First Submitted

February 12, 2019

First Submitted That Met QC Criteria

February 28, 2019

First Posted (Actual)

March 1, 2019

Study Record Updates

Last Update Posted (Actual)

March 17, 2023

Last Update Submitted That Met QC Criteria

March 15, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MED-EL BB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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