Two New Oticon Medical Products Gain FDA Clearance

MIPS Surgery Kit 4mm © Oticon Medical

New Minimally Invasive Ponto Surgery (MIPS) and Ponto BHX Implant: two new Oticon Medical offerings by Oticon Medical cleared now for marketing in the US.

New Minimally Invasive Ponto Surgery (MIPS), performed with minimal skin penetration and less interference to soft tissue than ever before, is a further refinement of the proven tissue preservation surgery for use with the company’s Ponto System. The new Ponto BHX Implant is the first implant with a laser-ablated titanium surface that promotes a faster and stronger bonding to bone and increases the strength of the bone-to-implant interface by more than 150%.

Oticon Medical has long recognized the benefits of tissue preservation surgery in bone anchored hearing surgery for reducing post-op complication and improving cosmetic outcomes. This week, Oticon Medical introduced a further refinement of the proven tissue preservation surgery for use with the company’s Ponto System. The new FDA-cleared Minimally Invasive Ponto Surgery (MIPS) is performed with minimal skin penetration and less interference to soft tissue than ever before. The reduced level of intervention aims to minimize post-op complications. A minor punch incision removes only the soft tissue that corresponds to the shape of the Ponto abutment. The suture-free surgery enables improved cosmetic outcomes for the patients, with no scar formation around the abutment site.

“For patients and surgeons, tissue preservation has been one of the most important surgical developments in the bone anchored hearing in terms of quicker surgery, shorter healing time and less numbness and pain,” said Oticon Medical President Jes Olsen. “With Minimally Invasive Ponto Surgery, we provide a truly new perspective on tissue preservation with strong patient benefits -- suture-free surgery with no scarring and aiming for fewer post-op complications.”

The second novelty recently approved by the American administration, the FDA-cleared Ponto BHX Implant, is a perfect match between Oticon Medical’s proven OptiGripTM geometry and the latest surface technology, taking osseointegration to the next level – bone bonding – and delivering the highest stability from day one.

“The unique BiohelixTM surface is the outcome of the latest research from world-leading experts of osseointegration in Gothenburg, Sweden,” says Oticon Medical President Jes Olsen. “By building on Brånemark osseointegration technology’s 40 years of excellent clinical results, we aim to improve clinical outcomes in patients with soft or compromised bone as well as offer increased implant stability margins for regular patients.”

Stronger than Bone, Highest Stability

The new Ponto BHX implant builds on the proven OptiGrip geometry. The Wide Ponto implant with OptiGripTM geometry has the highest level of initial stability of all bone anchored implants. Ponto BHX implants improve the biomechanical fixation even further and, at the same time, promote a faster and stronger bonding to the bone.

BiohelixTM - First Laser-Ablated Titanium Surface

An innovative site-specific laser modification at the roots of the threads of the OptiGripTM geometry creates a three level surface topography matching the natural bone structure at the macro-, micro- and nano-scale promoting bone-bonding and interface strength. In fact, the bone bonding to the BHX Implant is stronger than bone itself. The enhanced osseointegration provided by the Biohelix surface offers additional benefit, aiming to lower the loss rate among children and adults with soft and compromised bone.

On Oticon Medical MIPS - On Oticon Medical Ponto BHX Implant