Study Results
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View full resultsBasic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2012-05-31
2014-11-30
Brief Summary
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Detailed Description
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The Ponto implant has previously been available with a 3.75mm diameter and comes in two lengths: 3mm and 4mm. Anew Ponto implant that is 4.5mm wide in diameter is now available in both 3mm and 4mm lengths. This Wide Diameter implant is designed to maximize bone-to-implant contact area and enhance implant stability which can potentially allow loading of the sound processor as early as 3 weeks after surgery. The abutment screw incorporates external threads at the screw head to make it possible to connect a SmartPeg (Osstell, Goteborg, Sweden) for stability measurements. All Ponto implants have the same universal implant-abutment interface. Therefore, they are fully compatible with existing instruments and abutments. Two new countersinks have been developed for the new Ponto Wide Diameter implant. The drill size of the countersink is 3.80mm. It is marked with a "W" to separate them from existing drills. All products are CE-marked and cleared for the US market by the FDA.
Objectives The present study will attempt to show that the Ponto 4.5mm Wide Diameter implant has similar or better outcomes in terms of Quality of Life (QoL) benefit; implant extrusion and revision surgery when compared to the 3.75mm diameter implant. Secondary objectives to be studied will include adverse skin reactions, the feasibility of fitting the sound processor three weeks after surgical implantation, and investigation to see if the type of skin reactions observed following implantation could be related to the demographic data of subjects or the type of surgical technique used.
Study Design This study is a prospective, multicenter study of subjects' demographic and implant data. Subjects will be enrolled at two US sites.
Subject Population Twenty adult subjects 18 years or older will be included in the study from each participating partner site.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Wide diameter bone anchored implant
Intervention: Implantation of a wide diameter bone anchored auditory implant either 3 or 4 mm in length, into the skull on the side of the ear where intervention is intended in order to restore hearing. In the case of a conductive or mixed hearing loss, that side is chosen. In patients with unilateral, profound sensori-neural hearing loss the implant is implanted on that side but the sound is transmitted to the side with the normal hearing ear via bone conduction stimulation.
Wide diameter bone anchored implant
4.5 mm wide diameter bone anchored implant
Interventions
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Wide diameter bone anchored implant
4.5 mm wide diameter bone anchored implant
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 18 years of age or older
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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Oticon Medical
INDUSTRY
Responsible Party
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Principal Investigators
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Jack Wazen, MD
Role: PRINCIPAL_INVESTIGATOR
Sarasota Ear Institute
Locations
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Silverstein Institute
Sarasota, Florida, United States
Michigan Ear Institute
Farmington Hills, Michigan, United States
Countries
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References
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Wazen JJ, Babu S, Daugherty J, Metrailer A. Three-week loading of the 4.5mm wide titanium implant in bone anchored hearing systems. Am J Otolaryngol. 2016 Mar-Apr;37(2):132-5. doi: 10.1016/j.amjoto.2015.08.005. Epub 2015 Aug 18.
Other Identifiers
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Wide04262012
Identifier Type: -
Identifier Source: org_study_id
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