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BONEBRIDGE Bone Conduction Implant in Adults

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ClinicalTrials.gov Identifier: NCT03859648
Recruitment Status : Not yet recruiting
First Posted : March 1, 2019
Last Update Posted : May 17, 2019
Sponsor:
Information provided by (Responsible Party):
Med-El Corporation

Brief 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.

Condition or disease Intervention/treatment Phase
Hearing Loss, Conductive Hearing Loss, Mixed Device: BONEBRIDGE Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Outcomes in Adults With Mixed or Conductive Hearing Loss Implanted With the BONEBRIDGE
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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.

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03859648


Contacts
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Contact: MED-EL Corporation 1-888-633-3524 research.us@medel.com

Locations
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United States, Pennsylvania
The Hospital of the University of Pennsylvania Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Michael Ruckenstein    215-662-2777    michael.ruckenstein@uphs.upenn.edu   
United States, Tennessee
Vanderbilt University Not yet recruiting
Nashville, Tennessee, United States, 37235
Contact: David Haynes, MD    615-936-5000    david.haynes@Vanderbilt.Edu   
Canada, Ontario
London Health Sciences Centre Not yet recruiting
London, Ontario, Canada, N6A 5A5
Contact: Lorne Parnes, MD    519-685-8500    lorne.parnes@lhsc.on.ca   
Sponsors and Collaborators
Med-El Corporation

Publications:

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Responsible Party: Med-El Corporation
ClinicalTrials.gov Identifier: NCT03859648     History of Changes
Other Study ID Numbers: MED-EL BB
First Posted: March 1, 2019    Key Record Dates
Last Update Posted: May 17, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Hearing Loss
Deafness
Hearing Loss, Conductive
Hearing Loss, Mixed Conductive-Sensorineural
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms