Tag Archives: audiology

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

Evaluating Benefit and Monitoring Progress in Young Children with a Bone Conduction Hearing Device

Providing early access to sound is critical for children with prelingual hearing loss to develop speech and language skills on par with their typical hearing peers (Sininger, Grimes, and Christensen 2010; Bagatto et al. 2011, 2016; Tomblin et al. 2015). Evidence-based prescriptive formulae, such as DSL v 5.0 and NAL-NL2, are available in hearing aid fitting software and real-ear verification measures when fitting air conduction hearing aids to infants and children who have hearing loss (Scollie et al. 2005; Keidser et al. 2012).

However, strategies for fitting a bone conduction hearing device (BCHD) to a young child is lacking.  Additionally, the use of a consistent protocol within pediatric clinics for children with a BCHD has not been well defined.  In fact, a survey completed by Gordy and Bagatto (2020) found that audiologists are seeking guidance on how to provide optimal amplification to children who use BCHDs, and the aided audiogram is the only consistent measure used to verify BCHD fittings.

Given the limited availability of clinical tools, such as a skull simulator and prescriptive targets, audiologists need to consider other subjective test measures to use when fitting young children that are readily available in most pediatric audiology clinics.  These include, but are not limited to, parent report measures (e.g., The Auditory Skills Checklist, LittleEARs,) the Ling Six Sound Test, closed-set and open-set speech perception test measures, as well as standardized speech and language assessment measures.

As a leading manufacturer of bone anchored hearing solutions, we felt compelled to develop a suggested assessment protocol for monitoring the auditory skills of children ages three-to-five years fit with the Ponto bone anchored hearing system. This blog provides an overview of a straightforward assessment process that clinicians can incorporate into their fitting and management of young children with a BCHD.

Leveraging the Pediatric Minimum Speech Test Battery (PMSTB) developed by Kristin Uhler and colleagues in 2017, we created a streamlined assessment protocol for audiologists to consider when fitting young children with a BCHD.  This protocol is purely based on subjective assessment measures and a way for clinics to establish consistency among audiologists.  Beginning by verifying that a young child can detect the Ling Six Sounds, an audiologist would move to a closed-set speech perception test measure designed to evaluate a child’s pattern perception abilities and word identification skills.  Assuming the child demonstrated consistent word identification we suggest evaluating how the child responds to recorded open-set word and sentence recognition test measures. Finally, we recommend using a parent report measure to end the evaluation.

The protocol consists of a laminated card outlining the straightforward steps to evaluating benefit using a combination of speech perception measures, a parent report measure, and aided soundfield testing. The protocol provides guidance on the test administration, including suggested test level in dBA and calibration of the audiometric equipment.  A suggested test measures flow chart is provided along with a record sheet to document the child’s results. The protocol is recommended for all BCHD indications for a child ages three-to-five years.

Until a standardized objective verification protocol using a skull simulator with prescriptive targets is developed for young children, we would encourage clinicians to consider using this protocol or something similar to monitor a young child’s auditory development with a BCHD.

To learn more about this protocol, we encourage you to reach out to your regional clinical specialist 

About the Author

Carissa Moeggenberg is an audiologist who has worked in the hearing healthcare field for 29 years. She is presently the Training Manager for Oticon Medical.

References

1. Bagatto, M. P., S. T. Moodie, R. C. Seewald, D. J. Bartlett, and S. D. Scollie. 2011. “A Critical Review of Audiological Outcome Measures for Infants and Children.” Trends in Amplification 15 (1): 23–33. doi:10.1177/1084713811412056.

2. Bagatto, M., S. Moodie, A. Malandrino, C. Brown, F. Richert, D. Clench, and S. Scollie. 2016. “Prescribing and Verifying Hearing Aids Applying the American Academy of Audiology Pediatric Amplification Guideline: Protocols and Outcomes from the Ontario Infant Hearing Program.” Journal of the American Academy of Audiology 27 (3): 188–203. doi:10.3766/jaaa.15051.

3. Dave Gordey & Marlene Bagatto (2020): Fitting bone conduction hearing devices to children: audiological practices and challenges, International Journal of Audiology, DOI: 10.1080/14992027.2020.1814970

4. Keidser, G., H. Dillon, L. Carter, and A. O’Brien. 2012. “NAL-NL2 Empirical Adjustments.” Trends in Amplification 16 (4): 211–223. doi:10.1177/1084713812468511.

5. Scollie, S., Seewald, R., Cornelisse, L., Moodie, S., Bagatto, M., Laurnagaray, D., … & Pumford, J. 2005. The desired sensation level multistage input/output algorithm. Trends in Amplification, 9 (4): 159–197.

6. Sininger, Y. S., A. Grimes, and E. Christensen. 2010. “Auditory Development in Early Amplified Children: Factors Influencing Auditory-Based Communication Outcomes in Children with Hearing Loss.” Ear and Hearing 31 (2): 166–185. doi:10.1097/AUD.0b013e3181c8e7b6.

7. Tomblin, J. B., E. A. Walker, R. W. McCreery, R. M. Arenas, M. Harrison, and M. P. Moeller. 2015. “Outcomes of Children with Hearing Loss: Data Collection and Methods.” Ear and Hearing 36 (01): 14S–23S. doi:10.1097/AUD.0000000000000212.

8. Uhler, K., Warner-Czyz, A., Gifford, R. and PMSTB Working Groups. 2017. “Pediatric Minimum Speech Test Battery” J Am Acad Audiol 28:232–247. DOI: 10.3766/jaaa.15123

Welcome to the Presidential Perspective

We are launching a new column from the president of Oticon Medical North America, John Sparacio. Each month, John will share his perspectives on the hearing healthcare industry, insights into the future of implantable hearing devices, and provide guidance on how audiology practices and clinics can thrive. 

Hearing Healthcare in the New Normal

Moving Beyond Surviving to Thriving

The new normal. Bet you’re as sick of seeing that term in every news article, think piece, and social media pontification as I am. Unfortunately for us, it is the reality we are facing. Life, and the hearing healthcare industry as a whole, will simply not go back to what we used to call “normal” anytime soon—if ever.

So, what can we do about it from a business standpoint? I’ve been racking my brain over that for some time now, and while I’d like to say I came up with the answer, I am pretty sure there isn’t one, at least not a one-size-fits-all, capital A answer. However, what I did come up with is a way we can better navigate these uncharted waters—by sharing our experiences, including what has worked, what hasn’t, and what we believe will help our industry not only survive, but thrive. I will be sharing my experience and perspective monthly, and I hope you will stop by and not only give it a read but share your own thoughts and experiences in the comments.

Personally, I’ll admit this past year has been a doozy. I barely had time to settle in as the president of Oticon Medical North America when the challenge of guiding our business through the Covid-19 crisis landed in my lap like a ticking bomb. We had all just returned from a highly successful international sales meeting in Cancun, and our future outlook was as bright and sunny as that beautiful location.

Then… bam! Less than a month later, the coronavirus was identified, and the entire world began shutting down. I told our office staff they would be working at home for a couple of weeks (ha, I know), and then everything just… stopped. Our customers couldn’t open their offices, our sales team couldn’t travel, our events couldn’t be held, product launches were delayed… It was one door after another slamming shut. And with each one that closed, my fears for the future of our company and of our customers’ businesses grew.

So, what has gotten us through the darkest days of this crisis? Adaptation is top of my list. Worldwide, our leadership teams used robust scenario planning exercises to confront the challenges posed by the pandemic head-on. We maximized our communications infrastructure so that we could conduct meetings and events online. We provided our employees with the equipment required to work from home with as much ease and efficiency as possible. We supplied our field staff with the PPE needed to remain safe while still supporting our clinician and surgical customers.

In short, we adapted. And like any organism facing down a threat, our adaptation meant we survived. In fact, I’ll tiptoe out on a limb and go so far as to say we are thriving. Sure, sales could be better—that’s always true regardless of a worldwide pandemic! But in the course of adapting, we discovered smarter, more efficient ways to conduct business. These lessons will not be discarded once whatever passes for normalcy takes hold, but rather be used to make us an even stronger, more efficient leader in hearing device manufacturing. Which in turn will make us an even better partner to our hearing care professional customers reopening their businesses and relaunching their important services to patients, many of whom have had to postpone getting vital hearing care and are now eager for assistance.

So, back to the new normal. What is that going to look like when it comes to bone-anchored hearing devices and other hearing products and services? Well, some of the changes we’ve already seen, such as the increase in telehealth options, will be sticking around. As for whatever other changes and advancements are coming? I can only speak for my corner of the hearing industry, but there are indeed exciting innovations on the horizon in technology, product, and service offerings. I eagerly look forward to sharing them with you as we all move forward—together.

#

Only certain staff members are allowed into our Somerset US headquarters right now—essential workers. Who decides who is essential? Me. I found it weird carrying around a letter from me declaring myself an essential worker, so I simply bought the T-shirt.

 

 

Female audiologist

Reducing the Clinic’s Burden: Online Patient Resources from Oticon Medical

The demand to provide hearing healthcare services remotely has reached new levels this past year due to the COVID-19 pandemic. Remote hearing healthcare is not new—it has been discussed in audiology research circles for more than 20 years, been piloted and launched by Government Services and used by clinicians serving remote geographic locations.

TeleHealth, as defined by the World Health Organization, is “the use of electronic means to deliver information, resources and services related to health”. TeleHealth covers many domains, including electronic health records, mobile health, and health analytics. TeleHealth (also called eHealth) has the potential to provide more services to a wider population in a personalized manner. Prior to 2020, it was primarily intended to supplement in-person appointments, but has taken on a new meaning due to the recent pandemic and need for social distancing.

Reducing the burden on clinics by providing support for patient-related services and offering remote assistance to patients is a priority for us at Oticon Medical, which is why we have either created or further expanded several online support services for our hearing healthcare professionals over the last year. We detail a short summary of these services in this first blog of the New Year.

The Ponto Care™ App was expanded specifically to address the need for social distancing. It now 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 occur during their recovery process, thus empowering patients for simple, easy device care.

Replacement Processor Support is an essential service for you and your patients. Should your patient need a replacement sound processor, we will extract their current program from their non-functioning processor, load the program(s) onto their new sound processor and ship directly to the patient. This removes you from the process so that you can focus your time on clinically billable services.

Oticon Medical Online Support Pages

Patients often have many questions regarding the insurance reimbursement process during their journey to getting a Ponto System or when upgrading their current sound processor. In order to reduce the amount of time you spend counseling on topics related to insurance reimbursement we have expanded our online services to provide additional support for your patients. Our Insurance Support Team has posted online information that includes the list of in-network insurance providers, frequently asked questions, intake forms and direct contact information on how to reach a member of our team.

Additional online programs to assist your patients can be found on our website under Support.  This section of our website offers instructional product videos, online warranty registration and product use guides.

Ongoing guidance and support from other recipients who have been on the BAHS journey to better hearing play a key role in assisting patients who are new to this technology. We encourage you to direct your patients to our Oticon Medical Friends program

for a deeper connection that only another bone anchored recipient can impart, thus easing the amount of time you spend on counseling.

Finally, to provide a place for you to build your expertise about Oticon Medical’s products, we have partnered with Audiology Online to extend opportunities for you to attend live webinars or watch recorded webinars from the comfort of your home or office. These sessions are typically 60 minutes in length and offer continuing education credits. Topics include clinical evidence, product updates, product fittings and advanced clinical management of bone anchored recipients.

We Value Your Feedback

We are committed to continually evaluating the services we provide and developing innovative remote care solutions that present value to those customers who fit and receive our products. Should you have suggestions or ideas on how we can improve our remote service programs please let us know!

We wish you all the best for 2021! Your dedication and skill make a difference every day to those affected by hearing loss.

Strengthening Connections in Challenging Environments with the EduMic

Whether a child’s learning environment is in the classroom or virtually from their home, the ability to control the acoustics is difficult and underscores the need to optimize the overall speech signal.  Providing clear access to speech is critical for them to learn. Research has shown that children need quieter conditions and better signal-to-noise ratios than adults to have good speech understanding (Bradley & Sato, 2008). This is because children with developing language and auditory systems have a smaller vocabulary and are unable to rely on the redundancy of language to fill in missing words (Neuman, Wroblewski, Hajicek, & Rubenstein, 2010). Other studies have shown that an inability to understand the teacher due to poor listening conditions directly impacts the learning of new concepts (Yang & Bradley, 2009; Leibold, Hillock-Dunn, Duncan, Roush, & Bess, 2013). The exertion of mental energy and listening effort are also much higher when poor acoustic conditions exist (Bess, Gustafson, & Hornsby, 2014; McGarrigle, Gustafsson, Hornsby, & Bess, 2019).

The EduMic classroom solution

With the release of the EduMic™, Oticon Medical offers a unique solution for children to optimize listening effort in challenging environments. The EduMic – a remote microphone system (RMS) –features 2.4 GHz wireless technology and integrates with the Ponto 4 sound processor.  Built on the Velox STM platform, the EduMic features advanced signal processing, including Open Sound NavigatorTM technology. The EduMic preserves speech, operating within a wide bandwidth of 150 Hz to 10000 Hz while analyzing, balancing and applying noise removal to the streamed signal.  To improve the signal in outdoor environments, the EduMic also features Wind Noise Management, which employs an added level of “cleaning” to the signal.

While the primary function of the EduMic is in the microphone and transmitter mode, it has additional modes that are useful in and outside the classroom. The EduMic can stream stereo audio from various sources by connecting via a 3 mm jack cable, connecting to Frequency Modulation (FM) and Digital Modulation (DM) devices via a universal receiver, or it can function in telecoil mode. Additional features to help with the management of the device include LED indicators, a retention clip and protective skins.  The EduMic is robust and durable, provides stable transmission of the speech signal and provides the user with approximately 10 hours of use on a single battery charge based on internal device testing (EduMic Technical Data Sheet).   Figure 1 highlights the EduMic design and functionality.

Clinical evidence concerning EduMic supports both device usability and the improvement of speech understanding in complex listening environments. In fact, when the EduMic was subjectively evaluated by a group of educators, 80 percent reported a preference towards the EduMic over a competitive remote microphone system (RMS) and described it as “easy to use and comfortable to wear” (Gordey & Rumley, 2019).  When assessing the effectiveness in a noisy environment using a simulated classroom study design, the EduMic demonstrated improved speech understanding in children with hearing loss in both noise and noise plus reverberation environments when compared to using their hearing aids alone (Gordey & Rumley, 2019).

We encourage the use of the EduMic in all environments, including a child’s home where incidental learning occurs. This powerful solution provides children with an effortless transition into any environment because of its ease of use.  Finally, this product is a great balance of design and usability combined with advanced hearing technology to optimize the learning experiences of children with hearing loss.

To learn more about the EduMic and how it might benefit your patients contact your clinical specialist.

References:

Bess, F. H., Gustafson, S. J., & Hornsby, B. W. (2014). How Hard Can It Be to Listen? Fatigue in School-Age Children with Hearing Loss. Journal of Educational Audiology, 20, 1-14.

Bradley, J. S., & Sato, H. (2008). The intelligibility of speech in elementary school classrooms. The Journal of the Acoustical Society of America, 123(4), 2078-2086.

Gordey, D. and Rumley, J. (2019). Enhanced Learning with the EduMic. White Paper. Oticon, Inc.

Leibold, L. J., Hillock-Dunn, A., Duncan, N., Roush, P. A., and Buss, E. (2013). Influence of hearing loss on children’s identification of spondee words in a speech-shaped noise or a two-talker masker. Ear Hear. 34, 575–584.

McGarrigle, R., Gustafson, S. J., Hornsby, B. W., and Bess, F. H. (2019). Behavioral measures of listening effort in school-age children: examining the effects of signal-to-noise ratio, hearing loss, and amplification. Ear Hear. 40, 381–392.

Yang, W., & Bradley, J. S. (2009). Effects of room acoustics on the intelligibility of speech in classrooms for young children. The Journal of the Acoustical Society of America, 125(2), 922-933.

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 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.