Wide Diameter Bone Anchored Implant Study
| Status: | Completed |
|---|---|
| Conditions: | Other Indications |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/9/2018 |
| Start Date: | May 2012 |
| End Date: | November 2014 |
A Clinical Study of the Oticon Medical Ponto 4.5mm Wide Implant
To assess implant stability, implant loss, adverse skin reactions, and Quality of Life
Benefit following implantation of the Ponto 4.5mm Wide Diameter implant. Secondary: to
determine the feasibility of fitting the sound processor 3 weeks after surgical implantation,
and to investigate if the type of skin reactions following implantation could be related to
the demographic data of subjects and the type of surgical technique used
Benefit following implantation of the Ponto 4.5mm Wide Diameter implant. Secondary: to
determine the feasibility of fitting the sound processor 3 weeks after surgical implantation,
and to investigate if the type of skin reactions following implantation could be related to
the demographic data of subjects and the type of surgical technique used
Bone-anchored hearing systems have been an amplification choice for conductive, mixed, and
profound, unilateral, sensorineural hearing loss for over three decades. So far, about 75,000
patients worldwide have received this surgical intervention (bone-anchored hearing system),
since its first successful implantation in 1977. In 2009, Oticon Medical, LLC launched its
bone-anchored hearing system called Ponto. In just over two years, the Ponto has been
successfully implanted in over 3,000 patients by leading otolaryngologists and neurotologists
in 18 countries worldwide.
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.
profound, unilateral, sensorineural hearing loss for over three decades. So far, about 75,000
patients worldwide have received this surgical intervention (bone-anchored hearing system),
since its first successful implantation in 1977. In 2009, Oticon Medical, LLC launched its
bone-anchored hearing system called Ponto. In just over two years, the Ponto has been
successfully implanted in over 3,000 patients by leading otolaryngologists and neurotologists
in 18 countries worldwide.
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.
Inclusion Criteria:
- conductive, mixed or single sided deafness
- 18 years of age or older
Exclusion Criteria:
- younger than 18 years of age
We found this trial at
2
sites
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