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. 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.
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—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. 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.
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!
 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.  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  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  IBID  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