BONEBRIDGE Bone Conduction Implant in Adults
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|ClinicalTrials.gov Identifier: NCT03859648|
Recruitment Status : Recruiting
First Posted : March 1, 2019
Last Update Posted : February 27, 2020
|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|
|Actual Study Start Date :||August 26, 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03859648
|United States, Ohio|
|The Ohio State Wexner Medical Center University||Recruiting|
|Columbus, Ohio, United States, 43081|
|Contact: Meghan Hiss, AuD 614-366-1549 Meghan.Hiss@osumc.edu|
|Contact: Beth Miles-Markley 614-366-3687 Beth.Miles-Markley@osumc.edu|
|Principal Investigator: Oliver Adunka, M.D.|
|Sub-Investigator: Megan Hiss, AuD|
|United States, Pennsylvania|
|The Hospital of the University of Pennsylvania||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Hannah Kaufman 215-662-2777 Hannah.Kaufman@uphs.upenn.edu|
|Principal Investigator: Jason Brant, MD|
|Sub-Investigator: Hannah Kaufman, AuD|
|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||Recruiting|
|London, Ontario, Canada, N6A 5A5|
|Contact: Lauren Siegel 519-685-8500 Lauren.Siegel@schulich.uwo.ca|
|Contact: Kim Zimmerman, AuD 519-685-8500 Kim.Zimmerman@lhsc.on.ca|
|Principal Investigator: Sumit Agrawal, MD|
|Sub-Investigator: Kim Zimmerman, AuD|