BONEBRIDGE Bone Conduction Implant in Adults
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03859648|
Recruitment Status : Not yet recruiting
First Posted : March 1, 2019
Last Update Posted : May 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hearing Loss, Conductive Hearing Loss, Mixed||Device: BONEBRIDGE||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: Bone Conduction Implant
All subjects will be implanted with the bone conduction implant.
Bone Conduction Implant
- 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.
- 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.
- 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.
- 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
- 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.
- 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.
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
|Contact: MED-EL Corporationfirstname.lastname@example.org|
|United States, Pennsylvania|
|The Hospital of the University of Pennsylvania||Not yet recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Michael Ruckenstein 215-662-2777 email@example.com|
|United States, Tennessee|
|Vanderbilt University||Not yet recruiting|
|Nashville, Tennessee, United States, 37235|
|Contact: David Haynes, MD 615-936-5000 david.haynes@Vanderbilt.Edu|
|London Health Sciences Centre||Not yet recruiting|
|London, Ontario, Canada, N6A 5A5|
|Contact: Lorne Parnes, MD 519-685-8500 firstname.lastname@example.org|