OTICON-MEDICAL
12.7.2024 14:17:26 CEST | Business Wire | Press release
Oticon Medical announced today the U.S. Food and Drug Administration (FDA) clearance of its first active transcutaneous bone conduction hearing system, the Sentio System. Sentio System delivers the proven benefits of the Ponto™ System – and more – in a transcutaneous option.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240712765107/en/
The Sentio System includes an external Sentio 1 Mini sound processor and a Sentio Ti Implant placed under the skin. (Photo: Business Wire)
The system includes Sentio 1 Mini, an external sound processor, and Sentio Ti Implant, placed under the skin. It is the smallest transcutaneous system available to date1.
While Ponto and other percutaneous bone-anchored hearing systems use skin-protruding abutments, the Sentio System provides an alternative keeping the skin intact. The Sentio System offers an additional solution for patients and supports our commitment to "freedom of choice."
“With the launch of Sentio System, we provide best-in-class and the smallest active transcutaneous system. More importantly, Oticon Medical now offers a complete portfolio of bone-anchored hearing systems. This portfolio meets the needs of patients and customers, and fits diverse clinical settings and global reimbursement schemes for the treatment. We strongly believe that offering a broad portfolio is the path to achieving our mission to "Help more people" and give more potential users the quality of life improvements these systems offer”, says René Govaerts, President & General Manager, Oticon Medical.
The Sentio 1 Mini is designed with a focus on user comfort and ease of use. The device's design and slim profile make it 26% lighter than an alternative1. It gives access to a 360-degree sound experience and offers the widest bandwidth of 9.5kHz.
Sentio Ti is a SuperPowerful implant developed to support patient’s progressive hearing loss, without the need for additional surgeries. Sentio Ti is designed and verified for a higher maximum force output, so that patients can rely on its ability to handle more powerful sound processors2. From a surgeon’s perspective, the implant is designed for surgical flexibility, ensuring a straightforward procedure.
Sentio System is indicated for candidates aged 12 and older who have been diagnosed with conductive hearing loss, mixed hearing loss, or single-sided deafness.
This launch marks a significant milestone for Oticon Medical, as it continues to deliver the innovative hearing solutions that help people live life to the fullest.
For more information visit www.oticonmedical.com.
Not all products are available in all markets. Product availability and indications are subject to regulatory approval and may vary depending on the market.
About Oticon Medical
Oticon Medical is a global company in implantable hearing solutions, dedicated to bringing the power of sound to people at every stage of life. For more than a decade, we have made bone anchored hearing systems more accessible by simplifying the treatment for physicians, audiologists, and patients alike.
We believe that patients and hearing care professionals should be able to choose the best possible solution at any time along the patient journey. We call it “Freedom of Choice” and it has always been paramount to Oticon Medical. This is the reason why our solutions are designed to be compatible whenever possible. As a result, an implant from Oticon Medical stands as a true testament to our unwavering lifelong support.
We work collaboratively with professionals to ensure that every solution we create is designed with our users’ needs in mind. We have a strong passion to provide innovative solutions and support that enhance quality of life and help people live life to the fullest – now and in the future.
Because we know how much sound matters.
References
1 Sentio implant and sound processor physical features and comparison to other devices (Doc-00123204)
2 275144en Product Information Sentio 1 Mini
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240712765107/en/
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
FDA Issues Modified Risk Tobacco Product Orders for 20 ZYN Nicotine Pouch Products30.6.2026 18:19:00 CEST | Press release
FDA’s decision makes ZYN the first nicotine pouch product to receive MRTP orders authorizing reduced-risk claims versus cigarettes Philip Morris International Inc. (PMI) (NYSE: PM) today announced that the U.S. Food and Drug Administration (FDA) issued Modified Risk Tobacco Product (MRTP) orders for 20 variants of ZYN nicotine pouch products. These are the first MRTP orders granted for nicotine pouches, allowing PMI U.S. to market the following claim for the authorized ZYN products: “Using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.” “FDA’s decision is an important moment for the more than 45 million legal-age nicotine consumers in America,” saidStacey Kennedy, PMI U.S. CEO. “Today’s news ensures these adultshave access to accurate, science-based information, including FDA-authorized evidence that switching from cigarettes to ZYN reduces the risk of smoking-related diseases like heart disease
Caidya Announces Strategic Combination with Simbec-Orion Bridging Early Scientific Insight and Global Clinical Execution30.6.2026 17:00:00 CEST | Press release
Caidya today announced a strategic combination with Simbec-Orion designed to close the divide between early scientific insight and global clinical execution. The combination of Caidya and Simbec-Orion creates a differentiated specialty clinical CRO platform that enables programs to scale, maintaining focus, speed, and accountability. The strategic combination brings together complementary strengths to create a more complete development partner for innovative biopharma companies. With established operations across Europe, the Americas, APAC, and China, the combined organization provides meaningful expertise and execution capabilities in the regions that matter most. Simbec-Orion brings early-phase clinical pharmacology capabilities alongside deep therapeutic expertise for later stage complex oncology and rare disease trials, helping sponsors shape critical decisions early in the development lifecycle. Together, the organizations strengthen their ability to support complex, cross-border
Archer® Proves Purpose-Built AI Beats General-Purpose LLMs on Regulatory Change Management: 95% Verified Accuracy, 80x Faster, 92% Lower Cost30.6.2026 16:13:00 CEST | Press release
In a head-to-head benchmark, a leading general-purpose LLM was confidently wrong 35% of the time on regulatory dates. Archer Evolv™ shipped zero errors. For enterprises deploying AI in compliance, a wrong date is a missed deadline. The more dangerous failure is a wrong answer the model returns with high confidence, one that flows silently into a compliance calendar and is only discovered after the window has passed. Archer® today released results showing purpose-built AI beats a general-purpose large language model (LLM) on regulatory work, and it’s not close. This head-to-head test compared Archer’s purpose-built, vertical-specific AI and proprietary data sets against a leading general-purpose LLM, on a core compliance task: determining the publication, effective and comment-close dates of regulatory documents across six jurisdictions. General-purpose models are a genuine breakthrough, and this is no referendum on their quality. The question Archer set out to answer is narrower and mo
Altasciences Supports Key Development Milestone for Steel Therapeutics’ Lead Therapeutic Candidate, Fizurex™30.6.2026 16:08:00 CEST | Press release
Altasciences, a leading drug development organization, today announced a significant milestone in the development of Steel Therapeutics, Inc.’s pivotal toxicology study for its lead product candidate, Fizurex™, for the treatment of anal fissures. The successful completion of the study plays a significant role in the advancement of Fizurex™ toward first-in-human trials. The GLP-compliant study demonstrated a favorable safety profile, which has advanced Steel Therapeutics' plans to submit an Investigational New Drug (IND) application for Fizurex™ to the FDA in Q3 2026. Fizurex™, a patent-pending, single-use topical wipe, was designed to provide a standardized, accessible treatment option for a painful and often undertreated medical condition. The product builds on years of use through compounding pharmacy prescriptions and is now advancing toward clinical development and regulatory review. "We are proud to have supported Steel Therapeutics with the generation of the high-quality safety d
Interactive Brokers Expands Access to Korean Equities with Launch of Nextrade ATS30.6.2026 16:00:00 CEST | Press release
IB SmartRouting℠ Routes Orders to the Best Available Price Between KRX and Nextrade Interactive Brokers (Nasdaq: IBKR), an automated global broker, today announced the launch of select Korean equities through Nextrade, South Korea's first Alternative Trading System (ATS). The addition of Nextrade builds on Interactive Brokers' earlier launch of the Korea Exchange (KRX), through which it became the first major US-based broker to provide global investors with direct access to Korean equities. Clients trading on Nextrade benefit from significantly extended trading hours and access to additional liquidity. Interactive Brokers has enabled IB SmartRouting℠ across both the Korea Exchange (KRX) and Nextrade, automatically routing orders to the venue offering the best price. This helps clients achieve best execution while providing greater flexibility and more opportunities to participate in one of Asia's most dynamic equity markets. Korea's equity market ranks among the top global exchanges by
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom