Think lifelong patient outcomes before you choose an implant

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Godfrey Harper
6 years ago
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1 Think lifelong patient outcomes before you choose an implant Introducing a new wide implant in the Ponto System PONTO BONE ANCHORED HEARING SYSTEM

2 Everyday hearing challenges can be overcome Skin infections need to be reduced Typical patient challenges Patients deserve a safe treatment process 2

Lifelong patient outcomes are successful when everyday challenges are removed Although general benefits and success rates are high, improving outcomes for users of bone anchored hearing systems

Oticon Medical s starting point will always be the patient s everyday challenges and how to overcome them.

3 Lifelong patient outcomes are successful when everyday challenges are removed Although general benefits and success rates are high, improving outcomes for users of bone anchored hearing systems demands an ability to minimize not only treatment-related side effects but also hearing-related challenges, as these are decisive for the patient s long-term prospects and wellbeing. Oticon Medical s starting point will always be the patient s everyday challenges and how to overcome them. Everyday hearing challenges can be overcome To participate fully in today s society, users of bone anchored hearing systems must be able to communicate freely and interact in a natural way also in challenging auditory environments. Too many patients find it hard to cope with everyday situations such as meetings, crowded restaurants and other noisy places or when using cell phones or other modern appliances. Clinical studies prove that the appropriate application of sophisticated sound processing technologies can empower them to overcome many of these 2, 3, 4, 5, challenges. 6 Skin infections need to be reduced Skin problems constitute the most common complication from bone anchored hearing implants. These can lead to varying levels of discomfort or even pain. In most cases, issues can be solved through daily hygiene or by changing the abutment, but in other cases patients may be forced to undergo new surgery. Achieving healthy skin penetration in more patients can be supported through strong design concepts and the flexibility to adapt to different patient requirements. Patients deserve a safe treatment process The general implant success rate is high, but implant losses still constitute a significant problem in children and irradiated patients. Solutions that enable loading conditions to be improved are needed in order to increase success rates in these patient groups. 3

surface, with over 30 years of follow-up data confirming the

4 Implant Abutment Coupling Sound processor 4 Brånemark titanium surface The new wide Ponto implant has the Brånemark titanium surface, with over 30 years of follow-up data confirming the long-term safety in patients with bone anchored hearing systems.

New wide Ponto implant designed to improve stability Though treatment success rates are high, more can be done to reduce implant losses, especially in children and irradiated patients.

5 mm) with the new OptiGrip implant geometry to provide the largest initial bone contact surface in the industry. The resulting improvement in initial stability compared to the 3.

Implant Stability Quotient (ISQ) 70 65 60 55 50 45 62 59 Initial implant stability comparison 60 60 57 58 57 49 54 40 Wide Ponto implant 4.5 mm BIA 300, Cochlear BAS Ponto implant 3.75 mm Figure 1.

5 New wide Ponto implant designed to improve stability Though treatment success rates are high, more can be done to reduce implant losses, especially in children and irradiated patients. In order to address this need, the new wide Ponto implant has been designed to improve implant stability. Improved stability The implant combines a wider implant diameter ( 4.5 mm) with the new OptiGrip implant geometry to provide the largest initial bone contact surface in the industry. The resulting improvement in initial stability compared to the 3.75 mm Ponto implant has been confirmed in preclinical tests in artificial bone material. Studies investigating the clinical benefits are ongoing. Implant Stability Quotient (ISQ) Initial implant stability comparison Wide Ponto implant 4.5 mm BIA 300, Cochlear BAS Ponto implant 3.75 mm Figure 1. ISQ values measured after insertion of three different implants in artificial bone material (28 insertions for each implant). New possibilities for monitoring stability The new Ponto connection screw is compatible with the Osstell ISQ instrument for Resonance Frequency Analysis (RFA) using the Implant Stability Quotient (ISQ). One universal interface To simplify the monitoring of different implant and abutment interfaces, we adhere to the Ponto principle of a single, universal interface. This guarantees full backwards compatibility, and no alterations to either the surgical procedure or reusable instruments for the new wide Ponto implant. To make Ponto implants and interfaces simpler to identify and to make it easy to establish exactly which sound processor alternatives can be offered to patients the Ponto connection screw has been colored green.* *) The green ISQ compatible connection screw is incorporated in all abutment configurations for both earlier and new series of Ponto implants, with the exception of the angled abutment. 5

Maximized surface area and improved cutting performance The unique OptiGrip implant geometry

initial implant surface in contact with bone by 10% compared to any other bone This is achieved

required drill hole. This enables the threads to engage deeper in the bone.

5 mm 27% less bone removal Due to the smaller drill hole, the OptiGrip implant geometry reduces

This minimizes intervention and aims to reduce the risk of overheating. Ponto implant 3.

Initial implant surface in contact with bone achieved with three different bone anchored

6 Maximized surface area and improved cutting performance The unique OptiGrip implant geometry provides a significantly larger initial implant surface in contact with bone than any other bone anchored hearing implant. 10% larger initial implant surface in contact with bone The OptiGrip geometry increases the initial implant surface in contact with bone by 10% compared to any other bone anchored hearing implant. This is achieved though a maximized implant surface combined with unique cutting properties that minimize the required drill hole. This enables the threads to engage deeper in the bone. Initial contact surface Wide Ponto implant 4.5 mm 27% less bone removal Due to the smaller drill hole, the OptiGrip implant geometry reduces bone removal by 27% compared to other bone anchored hearing implants of the same diameter. This minimizes intervention and aims to reduce the risk of overheating. Ponto implant 3.75 mm BI300 by Cochlear BAS Figure 2. Initial implant surface in contact with bone achieved with three different bone anchored implants Maximized implant surface Unique implant geometry increases implant surface in contact with bone Easy insertion Unique cutting properties and a conical shape for easy guidance at insertion Optimal engagement Deeper engaging threads along the full length of the implant designed for improved bone grip 6

Experts behind the OptiGrip geometry Lars Jinton, Director of Engineering With over 20 years of experience in bone anchored hearing implants, Lars Jinton was responsible for mechanical design,

7 Experts behind the OptiGrip geometry Lars Jinton, Director of Engineering With over 20 years of experience in bone anchored hearing implants, Lars Jinton was responsible for mechanical design, implant testing and verification at bone anchored hearing companies including Nobel Biocare and Entific/Cochlear before moving to Oticon Medical. Factors such as implant and drill hole diameters are known to influence the initial stability of screw-shaped implants. Unique and ground-breaking technology allows us to provide an implant cutting performance that significantly reduces the required ratio between the implant and drill hole diameters. Patrik Westerkull, MSc. Eng. Ph. Formerly responsible for bone anchored development at Nobel Biocare, and founder of Entific, Patrik Westerkull is now Senior Research Consultant at Oticon Medical. The bone anchored hearing industry has really progressed during the last few years, and it is a privilege to be part of the latest developments. It is exciting to follow the various clinical research programs investigating the clinical benefits of moving to wider implant diameters as well as the possibilities offered by the new OptiGrip geometry. 7

Ponto 12 mm abutment Distance to shoulder: 9 mm Suitable for patients

8 Ponto angled abutment Distance to shoulder: 3 mm The 10 angled Ponto abutment can be used to adjust the angle of the sound processor. Ponto 12 mm abutment Distance to shoulder: 9 mm Suitable for patients with thick skin where a 9 mm abutment does not provide a sufficient distance to shoulder.

Adaptable solutions to meet different needs A platform for healthy skin penetration demands a strong implant and abutment design concept,

Over 3000 implantations with Ponto implants had been performed by January 2012.

1 A skin-friendly design concept The Ponto design concept is based on three principles aimed at preventing skin irritation and infection.

for bacterial growth and migration One size does not fit all The wide range of Ponto abutments offers the flexibility to adapt to different

Soft supporting shoulder Designed to delay skin thickening Perfectly matched interface Full skin support from underlying bone and

9 Adaptable solutions to meet different needs A platform for healthy skin penetration demands a strong implant and abutment design concept, as well as the flexibility to adapt to individual variations in skin thickness and different surgical techniques. Over 3000 implantations with Ponto implants had been performed by January Retrospective clinical data confirms good clinical outcomes with Ponto abutments. 1 A skin-friendly design concept The Ponto design concept is based on three principles aimed at preventing skin irritation and infection. Adaptability to different patient needs and surgical techniques Minimal movement of skin against the abutment Minimum pockets and pathways for bacterial growth and migration One size does not fit all The wide range of Ponto abutments offers the flexibility to adapt to different skin thicknesses, without having to perform additional surgery, by matching the distance between the implant flange and abutment shoulder. Soft supporting shoulder Designed to delay skin thickening Perfectly matched interface Full skin support from underlying bone and periosteum Distance to shoulder 100% tight conical seal Prevents any bacterial migration via the abutment-implant interface Ponto 9 mm abutment Distance to shoulder: 6 mm Suitable for patients with thick skin or constant re-growth of soft tissue. Ponto 6 mm abutment Distance to shoulder: 3 mm 9

A sound processor family preferred by patients In their daily

challenging listening situations from noisy environments to

Ponto s sophisticated sound technology has proven to make many

2, 3, 4, 5, 6 Speech understanding Ponto s unique Split

speech understanding in more situations.

preserve the subtle speech details that make speech easier to

Sound quality and listening comfort Ponto s unique 2-stage

automatic Wind Noise Reduction system reacts as soon as wind

Design and durability Ponto sound processors are designed for

10 A sound processor family preferred by patients In their daily life, users of bone anchored hearing systems face numerous challenging listening situations from noisy environments to outdoor activities. Ponto s sophisticated sound technology has proven to make many of these experiences more manageable. 2, 3, 4, 5, 6 Speech understanding Ponto s unique Split Directionality mode has demonstrated its ability to support speech understanding in more situations. 4 Meanwhile, the Speech Guard amplification strategy aims to preserve the subtle speech details that make speech easier to understand. Sound quality and listening comfort Ponto s unique 2-stage Feedback Management system is programmed to provide comfortable, feedback-free sound. To enhance listening comfort in outdoor situations, Ponto s automatic Wind Noise Reduction system reacts as soon as wind noise is detected. Design and durability Ponto sound processors are designed for ease of use, long-lasting durability and discretion. Over 30 reliability tests confirm their ability to support an active lifestyle. Ponto Pro Power has won the IF product design award 2012, for outstanding quality and design. Ponto Ponto Pro Ponto Pro Power White Silver Chroma Beige Mocca Brown Diamond Black 10

11 Clinical data confirms the benefits Several clinical studies have already confirmed the safety and benefits of the Ponto system. Comparative studies reveal numerous patient benefits related to sound quality, speech understanding and design plus a strong preference for Ponto processors. Clinical follow-up data also confirms high implant and skin penetration success rates. 1. Babu S, Fucci M, McKinnon B, Sockalingam R, Jernby K. The Ponto Bone Anchored Implant System: A Survey of Clinical Outcomes. Oticon Medical White Paper. February Bosman AJ, Snik AFM, Hol MKS, Mylanus EAM, Cremers CWRJ. Evaluation of Cochlear BP-100 and Oticon Ponto Pro Sound Processors. Poster at the 3 rd International Bone Conduction Hearing Craniofacial Osseointegration (Osseo) conference, Sarasota, Florida, US; March Bosman AJ, Snik A, Hol MKS, Mylanus EA. Evaluation of the Oticon Ponto Pro Power A Comparative Study. Poster at the 3 rd International Bone Conduction Hearing Craniofacial Osseointegration (Osseo) conference, Sarasota, Florida, US; March Gladdis B, Hill PR. A Comparison Study of New Bone Anchored Hearing Aid (BAHA) Devices: Preliminary Dataset. Presentation at 3 rd International Bone Conduction Hearing Craniofacial Osseointegration (Osseo) conference, Sarasota, Florida, US; March Ortega C, Draper K, Wycherly B, Wasen JJ. A Comparative Study of the Oticon Ponto Pro Bone Conduction Hearing System and Cochlear BP100 in Patients with Single Sided Deafness (SSD). Presentation at 3 rd International Bone Conduction Hearing Craniofacial Osseointegration (Osseo) conference, Sarasota, Florida, US; March Østergaard Olsen S, Glad H and Holme Nielsen L. Comparison of two bone anchored hearing instruments: BP100 and Ponto Pro. Posted online on September 15, 2011, International Journal of Audiology.

12 Ponto a complete solution A complete family of advanced sound processors Lifelong patient outcomes A skin-friendly abutment family OptiGrip geometry designed for improved stability

13 Tamper-resistant battery door Wear-resistant coupling Easy-to-use push button Water resistant nano coating Directional microphones Volume control 13

14 Ponto stands for Freedom of Choice For surgeons and audiologists, Ponto offers long-awaited freedom to recommend alternatives of the highest caliber. For users, it offers opportunities to experience new dimensions in sound quality as technology develops. In bone anchored hearing care, freedom of choice is a principle worth fighting for both now and in the future! Manufacturer: Oticon Medical AB Datavägen 37B, SE Askim, Sweden Phone: info@oticonmedical.com Office locations Americas: USA Oticon Medical LLC Somerset, NJ Phone: info@oticonmedicalusa.com Brazil Oticon Medical Ltda Botafogo Rio de Janeiro Phone: info@oticonmedical.com.br Canada Oticon Medical / Oticon Canada Ltd. Ontario, L5N 0A6 Phone: info@oticonmedical.ca Colombia CEAN Ltda. A.A Bogotá D.C Phone: info@oticonmedical.co Office locations Europe: Belgium Oticon Medical NL-1180 AP Amstelveen Phone: info@oticonmedical.nl Denmark Oticon Medical DK-2765 Smørum Phone: info@oticonmedical.dk Finland Oticon Medical SF Helsinki Phone: info@oticonmedical.fi France Oticon Medical F Gennevilliers Cedex Phone: info@oticonmedical.fr Germany Oticon Medical / Oticon GmbH D Hamburg Phone: info@oticonmedical.de Italy Oticon Medical / Oticon Italia Srl IT Firenze Phone: info@oticonmedical.it The Netherlands Oticon Medical NL-1180 AP Amstelveen Phone: info@oticonmedical.nl Norway Oticon Medical N-0103 Oslo Phone: info@oticonmedical.no Poland Oticon Polska Sp. z o.o. PL Warszawa Phone: info@oticonmedical.pl Spain GAES E Barcelona Phone: Website: Sweden Oticon Medical S Stockholm Phone: info@oticonmedical.se Switzerland Oticon Medical / Oticon S.A CH-4502 Solothurn Phone info@oticonmedical.ch United Kingdom Oticon Medical Hamilton, ML3 7QE Phone: info@oticonmedical.co.uk Office locations Africa: South Africa Oticon Medical Constantia Kloof 1709, Gauteng Phone: info@oticonmedical.co.za Office locations Middle East: Israel Medton Ltd. Tel-Aviv Phone: info@oticonmedical.co.il M51160US /

Audiological Manual. Ponto TM The Bone Anchored Hearing System

Audiological Manual. Ponto TM The Bone Anchored Hearing System Audiological Manual Ponto TM The Bone Anchored Hearing System Contents Fitting Introduction Introduction... 3 Fitting...4 Checking the abutment site... 5 Practice operating the sound processor... 5 Re-evaluate