BONEBRIDGE Bone Conduction Implant in Adults
Study Details
Study Description
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 |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Bone Conduction Implant All subjects will be implanted with the bone conduction implant. |
Device: BONEBRIDGE
Bone Conduction Implant
|
Outcome Measures
Primary Outcome Measures
- Number and proportion of subjects experiencing device related adverse events [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 [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
- Percent correct words recognition in quiet in implanted ear. [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 [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 [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 [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Adults, 18 years of age or older at the time of implantation
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Conductive or mixed hearing loss, defined as:
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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
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Mixed hearing loss with PTA for bone conduction thresholds better than or equal to 45dB at 500, 1000, 2000, and 3000 Hz
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Air-bone gap greater than or equal to 30 dB at 500, 1000, 2000, and 3000 Hz
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Ability to benefit from amplification as defined by a monosyllabic (CNC) word score of 30% correct or better
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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
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Prior experience with acoustic or bone conduction hearing aids, unless candidate is unable to wear amplification for medical reasons
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Able to complete testing materials in English
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CT scan indicating the patient's anatomy is adequate to enable placement of the implant
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Ability to undergo general anesthesia
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Appropriate motivation and expectation levels
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Stated willingness to comply with all study procedures for the duration of the study
Exclusion Criteria:
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Evidence that hearing loss is retrocochlear in origin
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Skin or scalp condition precluding use of external audio processor
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Suspected cognitive impairment or organic brain dysfunction
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Ohio State Wexner Medical Center University | Columbus | Ohio | United States | 43081 |
| 2 | The Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19104 |
| 3 | Vanderbilt University | Nashville | Tennessee | United States | 37235 |
| 4 | London Health Sciences Centre | London | Ontario | Canada | N6A 5A5 |
Sponsors and Collaborators
- Med-El Corporation
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- Badran K, Bunstone D, Arya AK, Suryanarayanan R, Mackinnon N. Patient satisfaction with the bone-anchored hearing aid: a 14-year experience. Otol Neurotol. 2006 Aug;27(5):659-66.
- Riss D, Arnoldner C, Baumgartner WD, Blineder M, Flak S, Bachner A, Gstoettner W, Hamzavi JS. Indication criteria and outcomes with the Bonebridge transcutaneous bone-conduction implant. Laryngoscope. 2014 Dec;124(12):2802-6. doi: 10.1002/lary.24832. Epub 2014 Aug 20.
- Schmerber S, Deguine O, Marx M, Van de Heyning P, Sterkers O, Mosnier I, Garin P, Godey B, Vincent C, Venail F, Mondain M, Deveze A, Lavieille JP, Karkas A. Safety and effectiveness of the Bonebridge transcutaneous active direct-drive bone-conduction hearing implant at 1-year device use. Eur Arch Otorhinolaryngol. 2017 Apr;274(4):1835-1851. doi: 10.1007/s00405-016-4228-6. Epub 2016 Jul 30.
- Sprinzl G, Lenarz T, Ernst A, Hagen R, Wolf-Magele A, Mojallal H, Todt I, Mlynski R, Wolframm MD. First European multicenter results with a new transcutaneous bone conduction hearing implant system: short-term safety and efficacy. Otol Neurotol. 2013 Aug;34(6):1076-83. doi: 10.1097/MAO.0b013e31828bb541.
- Sprinzl GM, Wolf-Magele A. The Bonebridge Bone Conduction Hearing Implant: indication criteria, surgery and a systematic review of the literature. Clin Otolaryngol. 2016 Apr;41(2):131-43. doi: 10.1111/coa.12484. Epub 2016 Feb 4. Review.
- Zernotti ME, Sarasty AB. Active Bone Conduction Prosthesis: Bonebridge(TM). Int Arch Otorhinolaryngol. 2015 Oct;19(4):343-8. doi: 10.1055/s-0035-1564329. Review.
- MED-EL BB