Monthly Archives: July 2021

Presidential Perspective

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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 international, 14 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

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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