Category Archives: Product Information

Presidential Perspective

Joys and Challenge of Overseeing a Business in Growth Mode

As I write this, I am overseeing the largest expansion of Oticon Medical US in our history. As you can imagine, this comes with its shares of joys and challenges as we blaze our way toward an exciting new future.

So, what’s going on? To start with, we are juggling three major overlapping product launches. One I’ve already shared—the premarket approval of cochlear implant sales in the US. The second, which I’m excited to share with you now, is the launch of the first style in our new family of bone anchored hearing systems, the Ponto™ 5 Mini (you’ll have to wait a bit more to hear about the third launch, but I promise you’re going to like it).

Introducing the Ponto 5 family of bone conduction hearing devices

If you haven’t read our press release yet, here is a rundown of what the Ponto 5 Mini has to offer. While it remains the world’s smallest and most discreet processor on the market, it also offers the same state-of-the-art reliability, durability, connectivity, and product quality our customers came to know and expect from Ponto 4. Additionally, Ponto 5 utilizes two of our proven BrainHearing™ technologies, the OpenSound Navigator™ and OpenSound Optimizer™ to provide wearers with greater access to sound than ever before. We confirmed this in a study that shows that these technologies improve speech understanding by 20 percent* and significantly reduce the listening effort needed to make sense of sound.[1] While traditional feedback systems have previously addressed feedback by reducing gain and removing the dynamics of sound, the OpenSound Optimizer analyzes amplified sound 56,000 times per second to detect and actually prevent audible feedback before it occurs.[2] Hearing care professionals no longer need to compromise on sound dynamics to reduce feedback and can fit Ponto 5 Mini wearers with up to 6 decibels (dB) more stable gain.

Raise your level of patient care with RemoteCare

Another unique feature of the Ponto 5 Mini is the introduction of the user-friendly Oticon RemoteCare platform, which allows wearers to have follow-up appointments and adjustments made remotely. Now, I know when audiology professionals see the words “remote care,” you might become worried that it means you will be expected to be on call 24/7. I want to assure you this is not the case at all! You will remain in full control of your schedule and appointments just as you do when arranging appointments with patients face-to-face. RemoteCare simply allows you to reduce the number of office visits for issues that can be easily remedied remotely, such as making tweaks to programs. The RemoteCare option is extremely beneficial for patients who either live far from your office, have busy schedules that make it hard for them to travel, or are too infirm to attend in-office appointments. And with ongoing concerns about Covid-19, it enables you to treat patients who otherwise might not feel comfortable meeting with you directly—and vice-versa depending on your personal health concerns.

I hope you’re enjoying the journey with us as we continue to expand our product and service offerings to you and your patients. For more information anytime, please contact your local Oticon Medical representative. In the meantime, I encourage you to keep an eye on our social media properties and share all the latest news with your own patient base through your Facebook, Twitter, LinkedIn, and other communications outlets. Oticon Medical’s rising tide is intended to lift all boats, so join us and enjoy the ride!

[1] Manuscript in preparation, Data on File - Clinical study BC102

[2] Data on file at Oticon Medical

*Increased speech understanding with OpenSound Navigator ON measured as a percentage relative to the baseline with OpenSound Navigator OFF.

 

Introducing the First Sound Processor in the Ponto 5 Family

The World’s Smallest Sound Processor is still a Ponto.

Oticon Medical is excited to announce the Ponto™ 5 Mini. This sound processor is packed with new technology providing outstanding sound quality to Ponto recipients while preserving the design and functionality that recipients have come to admire and depend upon. The new Ponto 5 Mini sound processor has a revolutionary approach to feedback and gives patients access to hear sounds from all directions. Additionally, Oticon’s RemoteCare for Oticon Medical enables patients to have their Ponto 5 sound processor adjusted remotely from the comfort of their own home while offering professionals greater clinical efficiency.

More sound to the brain

BrainHearing™ has been the foundation of everything we do at Oticon Medical for more than 30 years. It is based on extensive research on how to optimally support the brain’s natural process while listening especially when the environment becomes challenging. This research has guided the development of Oticon Medical’s solutions and continues to do so. New research confirms that this open soundscape gives the brain what it needs to create a better listening experience. It has been proven to give better speech understanding with less listening effort.[1] With BrainHearing technologies such as OpenSound Navigator™ and OpenSound Optimizer™ in Ponto 5 Mini patients now have access to more sound than ever before.

Clinical evidence evaluating the open sound experience of OpenSound Navigator giving users access to 360° of sound has proven that it improves speech understanding by 21%.1 Other, more traditional, sound processors improve speech intelligibility by removing sound using technologies such as directionality and speech prioritization. The open sound experience also significantly reduces the listening effort needed to make sense of sound. Pupillometry tests carried out on the OpenSound Navigator showed overall pupil dilation was reduced by 36%.1

Premium sound without audible feedback

Patients can enjoy the full dynamics of sound without having to worry about any unwanted sound interference because the OpenSound Optimizer technology in Ponto 5 Mini prevents audible feedback before it occurs.2

Historically, traditional feedback systems have only been able to overcome annoying whistling sounds by reducing gain and removing the dynamics of sound. While this certainly decreases feedback, it also reduces other sounds and can result in impaired speech understanding. The new OpenSound Optimizer in Ponto 5 defies conventional technology with a new, unique, and patented approach to feedback management. OpenSound Optimizer can detect and prevent audible feedback from occurring. This means you can fit patients with up to 6dB more gain without the risk of feedback.[2]

What does this mean for patients? Optimal gain throughout the day with no audible feedback, as the feedback is mitigated before it is about to occur. This provides an overall improvement in sound quality due to the increase in headroom, the additional available stable gain, and prevention of whistling.

Oticon RemoteCare

All aspects of Ponto 5 have been designed to make daily life easier for patients—including follow-up fitting. With the easy-to-use Oticon RemoteCare platform, they can now attend follow-up appointments and adjustments remotely. Recipients simply log into the Oticon RemoteCare app and attend an online fitting. Clinicians can adjust the patient’s program, create new programs, turn on features, and provide counseling using this intuitive platform.

Oticon RemoteCare saves travel time for patients, increases flexibility, and provides valuable insight into a patient’s home listening environment—all of which improve patient care.

The Ultimate in Reliability

The design of the Ponto 5 Mini has been extensively tested so you can be sure it meets the most stringent safety and quality standards. With this proven robustness, your users can rely on Ponto 5 Mini to deliver the performance they need, whatever their lifestyle.

To learn more about the revolutionary Ponto 5 Mini sound processor and its many features we are offering a one-hour CEU course through Audiology Online on October 27, 2021 at 12 PM Eastern (please click through link to register). For brochures and a product demonstration contact your regional clinical specialist.

About the Author

Carissa Moeggenberg is an audiologist who has worked with implantable technologies for 29 years. She is presently the Senior Manager of Clinical Training and Technical Services for Oticon Medical.

References

[1] Manuscript in preparation, Data on File - Clinical study BC102

[2] Data on file at Oticon Medical

Presidential Perspective

Why We’re Entering the US Cochlear Implant Market

Our business is poised to begin a new journey here at Oticon Medical in the United States. Last month, we announced that the US Food and Drug Administration (FDA) had granted us premarket approval for our Neuro cochlear implant system to treat individuals 18 years of age and older with bilateral severe-to-profound sensorineural hearing loss who are only able to obtain limited benefit from appropriately fitted hearing aids[1]. It’s important to note that the Neuro System is the first new cochlear implant technology to earn this premarket approval from the FDA in more than 20 years. Pretty impressive, right? As of this writing, we plan to make the Neuro System available to US hospitals and clinics later this year.

“But, John,” you might be asking. “There are already cochlear implant businesses dominating that space, including a certain other company that literally bears the product name. So why elbow your way into that market?”

That’s a fair question, but trust me, this move makes perfect sense when you consider the following:

The rate of cochlear implant utilization/provision in the US remains low at around 6 percent.[2]

The market potential is broader than many realize, meaning there is still plenty of room for entry by new cochlear implant providers to increase options and broaden accessibility. Oticon Medical has the capabilities and resources needed to bring proven expertise in cochlear implantation to thousands of Deaf and hard of hearing people in the United States. We will leverage our global reach and existing network of clinics and users to build long-term relationships critical to the successful delivery of services and support of the highest quality. Our hope is that by entering the market, we will bring additional attention to an underserved portion of the market.

We welcome the opportunities and the challenges.

We are excited to venture into this area of hearing treatment and undaunted by the potential barriers. We eagerly plan to earn our place in this service-intensive market. Remember, while it’s true we will be the proverbial “new kids” on the US cochlear implant market “block,” we have been selling cochlear implant systems in countries around the world for decades. Our Neuro Zti is the result of more than 25 years of experience in cochlear implant development, manufacturing know-how, and material science expertise. And while our competitors might have the benefits of name recognition and firm establishment in the United States, we are confident that the many proven benefits of our offering will quickly draw the attention of hearing care professionals and users alike. When they learn facts about the Neuro Zti like it having achieved an impressive cumulative removal percentage (CRP) of 1.05 percent after five years[3]—making it one of the most reliable implants in the CI industry—we believe that any skeptics will quickly become converts.

We are part of a large and reliable global hearing health company.

Oticon Medical alone might appear smaller than some of our competitors, but we are also a part of Demant, a $2B-plus company focused on hearing health technology and awareness. That positions us as a heavy-hitter in the hearing device manufacturing field when you consider all our divisions are parts of a cohesive and well-established whole. Meanwhile, we are still small and maneuverable enough to provide intimate and direct service to our hearing healthcare customers and consumers in ways that many larger businesses can’t. Our high quality product, top-notch customer service, and long-term trust-based customer and patient relationships combined will form a solid foundation for a unique CI value proposition.

We offer US patients a new, high quality, and reliable CI option.

Neuro Zti is one of the most compact sound processors on the market[4]. It also features a unique screw fixation system that aims at making the implant stable without the need for bone bed milling, which makes it a system that saves precious time in the operating room. Additionally, an independent study confirmed that, thanks to the rigid structure and the screw fixation system, Neuro Zti prevents pain and magnet dislocation during MRI exams using the most common equipment with the magnet in place.[5]

In the end it comes down to this—there is more than enough room in the US for us to enter the cochlear implant market, especially considering all the benefits our company and our Neuro Zti have to offer. So I encourage you to sign up for updates on our official cochlear implant release and join us on what will surely be an exhilarating ride into the future!

[1] Severe-to-profound hearing loss is determined by a pure-tone average (PTA) superior or equal (≥) to 70 dB HL at 500, 1000 and 2000 Hz. Limited benefit from amplification is defined by scores of 50% or less on Hearing in Noise Test (HINT) sentences in quiet or noise, in the best-aided listening condition. Unless already appropriately fitted with hearing aids, it is recommended that candidates undergo a hearing aid trial period of three (3) months.

[2] Sorkin D. L. (2013). Cochlear implantation in the world's largest medical device market: utilization and awareness of cochlear implants in the United States. Cochlear implants international14 Suppl 1(Suppl 1), S4–S12. https://doi.org/10.1179/1467010013z.00000000076

[3] Reliability Report 2020 Reporting to ANSI/AAMI CI86 Standard June 2020. https://wdh01.azureedge.net/us/-/media/medical/main/files/for-professionals/ci/reliability-report/224812us_pbr_reliability-report-2020_version-a_2020-11_low.pdf?la=en&rev=BE13&hash=D18D58BFC1C7D3372A3A389B581270BF

[4] IBID

[5]  Todt, I., Rademacher, G., Grupe G., Stratmann A., Ernst, A., Mutze S., Mittmann P. (2018). Cochlear implants and 1.5 T MRI scans: the effect of diametrically bipolar magnets and screw fixation on pain. Journal of Otolaryngology - Head and Neck Surgery (2018) 47:11

Celebrating 10 Years of Delivering Sound that Matters

Part 2 of 2

Part 2 of our series presents evidence that supports the principles championed by Oticon Medical – BrainHearingTM and Direct Sound Transmission. Read below to learn more about these important principles and how they affect patient outcomes based on 10 years of clinical evidence.

Proven Hearing Excellence

As an audiologist, wouldn’t it make your job easier if the simple act of providing a patient with access to sound through hearing technology always equaled excellent outcomes? However, it is not that simple. The right choice of a hearing system will impact every aspect of a recipient’s life – from a conversation with their friend to learning a new subject in school to enjoying a movie at the local theater. At Oticon Medical, our goal is to help our recipients invest their cognitive resources in understanding, remembering, interacting and enjoying, rather than just hearing. We cannot make all situations noiseless and easy, but our solutions should reward the user with increased performance when more effort is necessary to understand an important situation. Through BrainHearing and Direct Sound Transmission, Oticon Medical offers a unique solution for your patients with clinical evidence to support its advantages .

BrainHearing is the Foundation of Better Hearing

BrainHearingTM is the foundation on which we developed the Ponto™ 3 SuperPower (SP) and the Ponto 4 hearing systems. It is about the basic understanding of how hearing works and how the brain makes sense of sound with less effort. Building on our foundation of BrainHearing, we also offer the advantages of Direct Sound Transmission. Direct Sound Transmission delivers the most efficient transmission of speech and sound via the skull bone directly to the cochlea without skin dampening, providing access to a larger range of everyday sounds with less distortion.

The combination of these two principles [BrainHearing and Direct Sound Transmission] demonstrates a significant decrease in listening effort can be achieved with the Ponto 3 SP, as indicated by reduced pupil dilation (Bianchi, F, et al. 2019). This pupillometry study proves that Ponto 3 SP, with its higher MFO level can significantly reduce the effort needed to listen to speech in noise.

An Open and Balanced Sound Experience with OpenSound Navigator

Ponto 4 features the groundbreaking OpenSound Navigator™, offering speed and precision for constant access to 360° sound. The result is a truly open and balanced sound experience in complex listening situations, bringing significant improvement in speech understanding. In fact, clinical evidence indicates a 30% improvement in speech understanding in noise (Bianchi, F, Weile, J N, et al. 2020). Also noted in this same study was that 80% of recipients preferred wearing the Ponto 4 when in a complex listening environment.

These studies show how improved sound quality does not only mean the ability to hear better, but for the first time, learning, memory, and listening effort were evaluated in bone anchored recipients to assess benefits beyond better hearing. The novel research presented here strengthens the evidence that the choice of the system and sound processor may have implications on everyday life activities for your patients. This is why the advanced technology offered by Oticon Medical makes all the difference!

To summarize, ten years after the first recipient received their Ponto sound processor, we have worked strategically to gain insights from surgeons, recipients and clinicians in the field to develop products that improve patient care and outcomes with the Ponto device. Without this research, bone anchored recipients would not be able to benefit from a minimal, suture-free surgical procedure, simple and easy aftercare, improved quality of life and the significant hearing improvements that characterize the Ponto System. To learn more about the studies outlined in this blog please visit our website [insert address].

References:

Bianchi, F, et al. (2019). Benefit of higher maximum force output on listening effort in bone-anchored hearing system users: A pupillometry study. Ear Hear 40:1220-1232.

Bianchi, F, Weile, J N, et al. (2020). OpenSound Navigator™ for Ponto, Oticon Medical white paper 215170.

About the Author:

Carissa Moeggenberg is an audiologist who has worked in the hearing healthcare field for the past 28 years. She is presently the training manager for Oticon Medical.

Celebrating 10 Years of Delivering Sound that Matters

Part 1 of 2

As a clinical audiologist, I am rarely awestruck by manufacturing claims; however, I encourage all audiologists in the field to take a moment to review Oticon Medical’s 10-Year Evidence Campaign.  I’ve provided a  brief summary of this two-part series below. Following this review, please reach out to your clinical specialist if you would like additional information or have any questions on the evidence  highlighted in these two blogs.

A Small Procedure with Huge Benefits – The Minimally Invasive Ponto Surgery

When we think of a surgical procedure, I believe most of us envision cutting, sutures, pain and recovery. In fact, the implantation of a traditional bone anchored solution involves an incision, sutures, thinning of the soft tissue and a slower healing process. And like traditional bone anchored solutions, Oticon Medical also followed this path 10 years ago, until the introduction of the minimally invasive Ponto surgery (MIPS) procedure. This procedure has revolutionized the industry by offering patients a less-invasive approach to better hearing with a Ponto™ device. The MIPS technique is a suture-free procedure with a unique approach to tissue preservation that is completed in minutes. It is truly minimally invasive because the soft tissue excised exactly matches the shape of the percutaneous abutment. All preparations for the implant installation are done through this circular incision, eliminating the need for sutures and thinning of the soft tissue. Utilizing tailor-made surgical components, 80% of US surgeons have gravitated to this new procedure offering their patients a simple, safe and easy surgery with huge benefits.

The clinical evidence gathered over the past 10 years supports the benefits of the MIPS procedure  Recent studies suggest that 98% of patients report an improvement in their quality of life after Ponto surgery. The reported improvement is greater than for middle ear implants, and almost as significant as for cochlear implants (Hendry et al., 2016). Additional studies highlighting the features and benefits of the surgical aspects of the Ponto System can be accessed through the link.

Designed for Simple, Easy Care

A topic professionals often counsel patients on during the candidacy process is what type of aftercare is necessary following placement of the implant. Many candidates are reluctant to take that next step towards surgery because of aftercare concerns with regard to the abutment.

In an effort to improve tissue preservation, Oticon Medical has refined the model of the Ponto abutment utilizing a unique OptiFit™ design– offering a straight neck and perfect match to the soft tissue. Because of this design, the Ponto abutment family is a proven skin-friendly concept. What’s more, in 95% of follow-up visits, no skin-related aftercare treatment was required based on systematic literature review reporting on ten years of experience with the Ponto System (Lagerkvist et al, 2020). This indicates that six out of seven patients will not need treatment due to a skin reaction. As a professional, you could then expect less than one follow-up visit in 20 would require the need to take action when using Ponto abutments and the modern surgical technique. These outcomes are representative of what any patient choosing to undergo a Ponto surgery can expect.

New for our family of Ponto recipients is the Ponto Care app. This tool, specifically designed during social distancing times, provides your patients with an Aftercare section allowing them to access relevant information about everyday life with the Ponto, including user guides, instructional videos and a diary. More importantly, the Aftercare section allows recipients to monitor their implant site to ensure proper care is taken should an issue with the healing process occur. The app provides recipients with the ability to photograph their implant site documenting any changes that may occur over time. These photos can be shared or discussed with their healthcare provider should an issue arise during their recovery process, thus empowering patients and enabling simple, easy device care.

Stay tuned as next month we will continue with our 10-Year Evidence Campaign by reviewing the studies focused on Proven Hearing Excellence. 

References:
Hendry J, Chin A, Swan IR, Akeroyd MA, Browning GG.  The Glasgow Benefit Inventory: a systematic review of the use and value of an otorhinolaryngological generic patient-recorded outcome measure. Clin Otolaryngol. 2016; 41(3):259-75.
Lagerkvist, H, et al. (2020). Ten years’ experience with the Ponto bone anchored hearing system – a systematic literature review (under review).

About the Author

Carissa Moeggenberg is an audiologist who has worked in the hearing healthcare field for the past 28 years. She is presently the training manager for Oticon Medical.