Category Archives: Surgery

A Reconstructive Surgeon Shares His First MIPS Experience

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Dr. Youssef Tahiri performed his first combination of ear reconstructive surgery and minimally invasive Ponto™ surgery (MIPS) in December of 2022. The procedure was conducted on a pediatric microtia/atresia patient, Sean, under general anesthesia (due to the reconstruction) in a surgical center under the guidance of an Oticon Medical representative.

Previously, Sean wore his Ponto processor on a softband, which he received when he was only three months old. At the age of 8[1], it was determined that Sean had reached the right age and bone density to proceed with implantation so he could wear his new Ponto 5 SuperPower on an abutment for improved access to sound.

The following is an interview conducted by Oticon Medical with Dr. Tahiri regarding his experience with the procedure.

Did you encourage Sean’s parents to move forward with implantation

I definitely encouraged them to move forward with MIPS to help with hearing on Sean’s microtia/atresia side. Sean had been using the Ponto already and were loving the product. Importantly, he was very comfortable with the Ponto. So we all agreed to go ahead with a Ponto implant system placement.

How long did Sean’s procedure take?

The MIPS portion took approximately 20 minutes.

How did your Oticon Medical representative assist you in working with Sean and his family?

She was so useful since it was my first time using the Ponto system. She supported me through the different steps of the procedure. She made sure we had everything we needed for a successful procedure.

In this experience, did your patient experience a significant improvement in performance/hearing after implantation vs. wearing the processor on a softband?

Absolutely! His hearing outcome was significantly improved after implantation as compared to the softband.

What would you like other surgeons to know about MIPS who might not have tried it yet?

It is a straightforward and easy procedure. The risks are minimal while the benefits are great. Hearing is so important and thus implantation should not be delayed (once deemed medically safe for the patient), particularly with such a minimal, simple procedure.

Click through the link to watch what Sean and his mother have to say about his Ponto 5 SuperPower and experience undergoing MIPS.

About Dr. Tahiri

Dr. Youssef Tahiri is a Board Certified Plastic and Reconstructive Surgeon with a subspecialty in Craniofacial Surgery. After graduating from McGill Medical School, in Montreal, Canada, he completed his Plastic and Reconstructive Surgery residency at McGill University and a Craniofacial Surgery Fellowship at the University of Pennsylvania and the Children Hospital of Philadelphia. He also pursued a Masters Degree in Experimental Surgery, which he obtained with Honors. He embraces the most innovative, cutting-edge technique available in craniofacial and microtia surgery. He has published a very large number of peer-review articles and presented his work at numerous regional, national and international scientific meetings. His research interests include outcomes evidence based clinical studies and translational research to enhance patients’ care and safety through improved techniques and technology.

[1] MIPS is recommended for: 
- Adult patients with normal bone quality and bone thickness above 3mm, where no complications during surgery are expected
- Children with normal bone quality and a bone thickness above 4mm (typically 12 years or older), and other known factors have been considered and found suitable for single-stage surgery
- Patients, as per above, with a skin thickness of 12mm or less
Refer to Surgical Manual for complete information on MIPS

 

Presidential Perspective

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Why won’t good bone conduction candidates get implanted?

One of the most common challenges our hearing care professionals face is encouraging patients to undergo surgery to implant the Ponto™ implant system. It is understandable that many individuals balk when they hear the word “surgery,” particularly if they are parents of children old enough to be implanted. From my substantial experience in medical device sales, I’ve learned that the best way to overcome user objections is with facts. Fortunately, when it comes to minimally invasive Ponto surgery (MIPS), we have substantial data on the benefits of wearing processors on an abutment.

With that in mind, here are five of the most common objections to having minimally invasive Ponto surgery (MIPS) and our suggested responses.

Objection 1: I don’t want to have general anesthesia.

As any credible medical professional will tell you, there is always some risk associated with general anesthesia. Parents often express this concern with regards to their child undergoing implantation. You can help your patient (or their parent) feel better about undergoing the procedure by explaining that MIPS usually only takes about 15-30 minutes and is often performed using other types of anesthesia. In many cases, the procedure may not even be done in a hospital.

Objection 2: If I don’t need surgery for the Ponto to work, then why should I have it?

While it is true that patients who wear their Ponto processor on a softband still receive hearing benefits, implantation increases these benefits significantly. You can explain that when worn on an abutment your patient can expect better results. The Ponto on an abutment uses Direct Sound Transmission, which prevents sound dampening—a common issue with magnet and softband systems. It also allows Ponto devices to reproduce a greater variety of sounds. The sound waves are mechanical, and the signal is transmitted with minimal loss when the source of the signal and its receiver are directly connected by a conductor like our titanium implant. In comparison, sound transmission from a processor on a softband results in signal loss, as it transmits through skin, fascia, and other tissue on its way to the bone.

You can also show your patient this video to illustrate the differences between hearing through a Ponto on a softband vs. an abutment.

Objection 3:  I don’t want to lose time recovering from surgery.

Nobody wants to take significant time away from work or their home/social life for a long surgical recovery. Fortunately, you can reassure your patient that this is a small, usually outpatient procedure with an expectation of same-day admission and release. This is particularly true when utilizing the MIPS or MONO drill technique, which further simplifies treatment and reduces surgical time and the risks associated with surgery. In most cases, it takes no more than a day or two to recover from the procedure. After surgery, the patient can expect to wear a bandage or other protective covering for a couple of days during which time the biggest inconvenience will be not washing their hair.

Objection 4:  I don’t want to risk any potential side effects or negative outcomes.

Although there is never zero risk of side effects or other issues from any kind of surgery, you can reassure your patient by explaining that this is a minimally invasive technique that eliminates the need for suturing by using a smaller incision. This allows for fast recovery and fewer complications. In 95 percent of follow-up visits, no skin-related aftercare treatment was required. Plus there is a 98 percent implant survival rate with the Ponto implants.[1]

As for cosmetic concerns, MIPS was designed to avoid the need for stitches, which reduces scarring and allows the patient’s hair to grow back as it was before surgery.

Objection 5:  I don’t want the expense of a surgical procedure.

This one can be tricky, as coverage for any surgical procedure will vary depending on the kind of insurance your patient has. You can feel free to contact your Oticon Medical representative for general guidance on insurance coverage or you can direct your patients on a case-by-case basis to contact their insurance company directly or speak to our Insurance Support Team to find out what their insurer will or won’t cover.

Have you run into these objections or others when it comes to bone anchored implantation surgery? Share what you’ve heard and how you’ve managed them in the comments below! And if you need more advice on counseling your patients for PONTO MIPS procedures, please contact your Oticon Medical representative.

[1] Lagerkvist H, et al. Ten years’ experience with the Ponto bone anchored hearing system – a systematic literature review. Clin Otolaryngol 2020 Sep; 45(5): 667–680.

Presidential Perspective

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Successful Hearing Healthcare: It’s All About the Patient Experience

There are so many different pieces of advice, best practices, tips, and tricks for clinicians out in the zeitgeist, you’ve probably heard or read them all. From my perspective, they all boil down to the patient experience. If you provide patients with a superior experience working with you during each stage of their hearing treatment process, success will follow naturally.

When it comes to defining patient experience, I default to the Golden Rule: treat others the way you would want to be treated. In this scenario, begin by putting yourself in your patient’s shoes.  They have lived at least part of their life with little to no hearing and experienced its associated hardships—struggling to keep up with conversations, falling behind in school or at work, and feeling fatigued every night after straining to hear all day. Yet you are leery of treating your hearing loss with a bone anchored hearing system (BAHS) because it involves surgery, you aren’t sure if your insurance will cover it, and all of the other standard objections.

Now ask yourself: how you would want to be treated by your hearing care professional during your journey to better hearing?

Starting down the path to improved hearing

We are fortunate here at Oticon Medical to have an engaged and informative team of patient advocates who have shared their experiences—positive and negative—in detail over the years. What I have learned from them is the following:

  • Patients want their hearing care professional to get to know them as a person with unique experiences related to their hearing loss, not just as the next appointment on someone’s schedule
  • They want you to provide as much information about each treatment option as possible, not just be handed a list of potential solutions and expected to do their own research
  • They want to know they can depend on you and the manufacturer of their selected device for continued support, not only immediately after implantation and activation, but for as long as they have their BAHS
  • They want to know they can afford the surgery, the device, and their visits to you pre- and-post implantation. Willingness to work with them to arrange financing and being able to help them understand their insurance coverage options will help you stand out from your competition
  • They want you to be clear, realistic, and honest about the pros and cons of bone anchored hearing with regards to the surgical procedure, the device, and post-implant expectations

A common goal makes Oticon Medical your partner of choice

When you and your patient select a Ponto BAHS, you get more than a highly effective product that requires only minimally invasive surgery. You get a partner in helping you provide the excellent customer service your patient expects and deserves. We also believe in getting to know our Ponto users making them feel like part of an extended Oticon Medical family by offering our advocacy program, online support groups, put them in touch with current wearers, and much more. We provide clear and detailed information about our products and services on our website and in brochures and guides so that your patients can quickly and easily get their questions answered about life with a Ponto.

Our Customer Service Team is available from 8 am to 8pm Eastern Time daily to support patients for as long as they have their Ponto device, and additional support can be requested through email 24/7 or through social media by sending direct messages to us via Facebook, or as members of Oticon Medical Friends.

We also have an Insurance Support Team that can help users find out what their insurer covers, either private or Medicare/Medicaid, and assist them with filling in all the paperwork required to get their surgery and Ponto device.

Now introducing an even better patient surgical experience: MONO

As for the surgical procedure itself, we have introduced the world’s first one-step drilling procedure for BAHS: the MONO treatment for adults 18 years of age and older. Our unique drill allows you to create a complete osteotomy in a single step. This groundbreaking new procedure offers your patients excellent aesthetic outcomes and fast recovery times.1,2 MONO can also help improve your procedural efficiency by reducing the number of instruments and implant components needed in the procedure. With the tailor-made MONO Surgery Kit, your staff will find it easy to prepare for and handle implant installation. And clinics that already use the minimally invasive MIPS technique have reported reduced surgical time, staffing, and running costs.3

You can book a demonstration of the MONO drill and find out how it can benefit you and your procedural efficiency today!

References

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1. Caspers CJI, et al. A clinical evaluation of minimally invasive Ponto surgery with a modified drill system for inserting bone anchored hearing implants. Accepted in Otol Neurotol 2020.
2. Holmes S, et al. Tissue preservation techniques for bone anchored hearing aid surgery. Otol Neurotol. 2021; Publish Ahead of Print.
3. Sardiwalla Y, et al. Direct cost comparison of minimally invasive punch technique versus traditional approaches for percutaneous bone anchored hearing devices. J. Otolaryngol Head Neck Surg. 2017;46(1):46.

Counseling Patients through the Ponto Trial Journey

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Benefits of Direct Sound Transmission

Patients considering a bone anchored solution for their hearing loss have many options.  As clinicians begin the process of discussing patient choices there are many factors patients often consider, including sound processor style, surgical features, wearing comfort, and cosmetic appeal. However, the candidate often overlooks or undervalues intangible benefits. These benefits relate to the importance of a solution that provides clarity of the signal without distortion or feedback, ample amount of power output to overcome the hearing loss and a broad frequency response to capture all of the acoustic elements important for the understanding of speech.

Bone anchored hearing devices can be placed into two broad categories: either they deliver sound via Skin Transmission, where the vibrating unit is placed on top of the skin and the sound vibrations have to pass through the skin and are attenuated before they reach the bone or via Direct Sound Transmission, with sound vibrations going directly to the bone and then on to the inner ear. Skin Transmission solutions are non-surgical options (e.g., a softband) versus Direct Sound Transmission percutaneous solutions, where the processor sends sound information through the skin to an implanted vibrating unit in direct contact with the bone.

Is there a difference between these two solutions?

Clinical evidence comparing patient outcomes between a skin transmission device and a direct transmission device indicates there is a significant difference. It has been shown that hearing thresholds obtained with Direct Sound Transmission solutions are about 5-20 dB lower (better) between 600 and 6000 Hz and speech reception thresholds are also 4-7 dB lower (better) than with conventional devices (Håkansson et al., 1984; Verstraeten et al., 2009). Beyond this fact, research shows that by choosing Direct Sound Transmission, such as a Ponto percutaneous solution, recipients can learn faster and remember more Pittman (2019) and Lunner et al. (2016) found that using Direct Sound Transmission can increase the learning speed in children by 2.5 times and improve recall abilities by 13 percent in adults.

It is widely established that children with a hearing loss have a reduced vocabulary compared to normal-hearing children (Blamey et al., 2001; Pittman et al., 2005). Hearing solutions for children with a hearing loss should help to close this gap. This is why the results seen by the Andrea Pittman (2019) study are so significant. The Pittman study is the first to show the influence of different sound transmission pathways on the essential domain of auditory learning with the effects of Direct Sound Transmission clear – children learn new words faster.

It has been shown that adults with hearing loss use many additional cognitive resources to recognize, listen to and process sounds. One of these cognitive resources is our working memory. Working memory can be used for both processing and storing information. Thus if more resources are used for processing, fewer resources are left for storage. In fact the ability to remember information can be used as an estimate of how many resources are left for storage, and how effortful it was to process that signal. Lunner and colleagues (2016) compared the ability to remember information using Ponto connected to either a softband (Skin Transmission) or an abutment (Direct Sound Transmission). Their results showed that the Ponto users’ recall ability was significantly higher with the sound processor connected to the abutment (52%) as compared to the Softband solution (46%). These findings suggest that transmitting the sound via Direct Sound Transmission to the temporal bone without skin dampening yields better signal quality and less effortful processing.

 

To summarize, the Ponto System uses Direct Sound Transmission, allowing for the most efficient transmission of speech and sounds via the skull bone directly to the cochlea without skin dampening. With the most powerful abutment-level sound processors available on the market, we can provide access to a larger range of everyday sounds with less distortion.

We believe that counseling on the benefits of a system beyond what is concrete to the patient will impact their future hearing outcomes and contribute to their overall quality of life. So, moving patients from softband to an abutment should include discussion of the advantages of Direct Sound Transmission.

To learn more about the benefits of direct sound transmission, we encourage you to register for our upcoming training on March 24, 2021 or reach out to your regional clinical specialist.

 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.

References:

Blamey, P. J., Sarant, J. Z., Paatsch, L. E., Barry, J. G., Bow, C. P., Wales, R. J., Wright, M., Psarros, C., Rattigan, K., Tooher, R. (2001). Relationships among speech perception, production, language, hearing loss, and age in children with impaired hearing. Journal of Speech, Language, and Hearing Research 44: 264–285.
Håkansson, B., Tjellstrom, A., Rosenhall, U. (1984) Hearing thresholds with direct bone conduction versus conventional bone conduction. Scand Audiol 13: 3-13.
Lunner, T., Rudner, M., Rosenbom, T., Ågren, J., and Ng, E.H.N. (2016) Using Speech Recall in Hearing Aid Fitting and Outcome Evaluation Under Ecological Test Conditions. Ear Hear 37 Suppl 1: 145S-154S.
Pittman, A. L., Lewis, D.E., Hoover, B.M., and Stelmachowicz, P. G. (2005). Rapid word-learning in normal-hearing and hearing-impaired children: Effects of age, receptive vocabulary, and high-frequency amplification. Ear Hear 26: 619–629. Plack, C. J. (2005). The sense of hearing.
Pittman, A. L. (2019) Bone conduction amplification in children: Stimulation via a percutaneous abutment vs. a transcutaneous softband. Ear Hear.
Verstraeten, N., Zarowski, A. J., Somers, T., Riff, D. and Offeciers, E. F. (2009). Comparison of the audiologic results obtained with the bone anchored hearing aid attached to the headband, the testband, and to the “snap” abutment Otol. Neurotol 30: 70-75.

Celebrating 10 Years of Delivering Sound that Matters

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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

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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.