Oticon Medical AB

ASKIM, Sweden--(BUSINESS WIRE)-- 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: 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 pro 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 . 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

Cochlear’s planned acquisition of Oticon Medical was announced at the end of April, when Cochlear offered a total of 850 million kroner, or about $120 million, to purchase Oticon from parent company Demant. The U.K.’s Competition and Markets Authority is escalating its investigation into Cochlear’s planned acquisition of Demant subsidiary Oticon Medical, based on concerns that the merger could stanch competition in some areas of the hearing device market. The agency announced its decision Tuesday, following a short grace period during which it had given Cochlear and Oticon the chance to “offer acceptable undertakings” that would assuage the anticompetition concerns. Suitable offerings never arrived, prompting the agency to recommend an “in-depth investigation” into the merger. "These steps in the transaction process are in line with what we expected in this complex case, and it does not change our expectations of the final result or the timing of the divestment. We believe we can meet and respond to the concerns, and we will continue to address the matters raised," Demant said in a statement sent to Fierce Medtech. "It is still our strategic decision to discontinue our hearing implants business area, as we believe it is in the best interest of both patients and customers, and we stand by our agreement to negotiate with Cochlear, the global leader in implantable solutions for hearing loss," the company added. A spokesperson for Cochlear didn't offer a statement on the upgraded investigation, but pointed toward the company's Dec. 7 notice (PDF) on the results of the initial inquiry, in which CEO Dig Howitt said, "Driven by our mission to innovate and help more people to hear, Cochlear remains committed to the proposed acquisition so that Oticon Medical’s recipients will have access to our innovative technologies and ongoing support for a lifetime of hearing outcomes." The acquisition was announced at the end of April. Under the terms of the deal, Australia-based Cochlear would acquire hearing implant maker Oticon from its parent company, the Danish device developer Demant. Cochlear offered 700 million Danish kroner in upfront cash and another 150 million kroner to be paid out within 18 months of the deal’s close for a total purchase price of 850 million kroner, or about $120 million. At the time, Cochlear and Demant suggested the deal would close sometime in the second half of this year, pending the necessary regulatory approvals. But that timeline is likely dashed now that the U.K.’s competition agency is taking a closer look at the merger. It first launched an inquiry into the deal—in what’s termed a phase 1 investigation—in October, when it gave “any interested party” two weeks to submit comments on whether the acquisition posed a threat to competition among hearing implant makers. In mid-November, the agency served Demant an initial enforcement order (PDF), asking it to continue running Oticon as usual and keep Oticon’s business separate from Cochlear while the agency conducted its inquiry into the proposed combination. By the beginning of this month, the antitrust authority had concluded that the merger could indeed threaten competition in at least one area of the hearing device market. A Dec. 6 press release detailed the findings of the inquiry, including an analysis showing that combining the companies would give them a “90-100% share of the bone conduction solutions market in the U.K.” The agency noted its concerns that the loss of competition could not only slow the pace of innovation in bone conduction technology, it could also lead to a reduction in the quality of the companies’ devices and a jump in prices for patients that would go unchecked without any viable competitors. However, since Oticon holds only a “very small position” in the cochlear implant segment, the agency concluded that the merger wouldn’t box out other competitors in that specific realm. With Cochlear and Oticon declining to offer up any ameliorating concessions during the ensuing five-day response period, the agency issued its decision (PDF) Tuesday to ramp up the probe into a phase 2 investigation. In the in-depth inquiry—which will stretch until June 5 of next year—the agency will first look more closely at whether the merger falls under its trust-busting jurisdiction and, if so, move forward in determining whether the deal would create a competition-killing monopoly in the U.K. If it comes to the same conclusion as it did in the phase 1 investigation, it could force the companies to take certain remedial actions before completing the acquisition or attempt to block the deal from going through at all. Editor's note: This story was updated on Dec. 21 to add responses from Cochlear and Demant.

The Neuro System will help treat individuals 18 years or older with bilateral severe-to-profound sensorineural hearing loss The advanced cochlear implant system is already available in 51 countries. (Credit: Oticon Medical) Oticon Medical has secured premarket approval (PMA) from the US Food and Drug Administration (FDA) for its Neuro cochlear implant system. The Neuro System is claimed to be the first new cochlear implant technology to secure FDA premarket approval in over 20 years. It is indicated for the treatment of individuals 18 years or older with bilateral severe-to-profound sensorineural hearing loss. The advanced cochlear implant system, which is already available in 51 countries, enables to provide enhanced sound quality. Oticon Medical plans to make the Neuro System available to US hospitals and clinics this year. Oticon Medical North America president John Sparacio said: “We are committed to ongoing innovation in hearing implant technology and support now and in the future for cochlear implant candidates, users and professionals. The Neuro System is an outstanding example of that commitment.” The Neuro Zti offers a future-proof electronic platform to enable patients to hear a variety of sound in everyday life. Oticon has optimised the design of the Neuro Zti implant to facilitate a minimally invasive surgical procedure and minimise complications associated with healing. According to the company, the Neuro 2 sound processor is the smallest behind-the-ear processor on the market. The sound processing technology is based on an Oticon Hearing Aid platform, which incorporates advanced hearing aid technology. Oticon Medical president Jes Olsen said: “Earning FDA premarket approval for the Neuro System is a significant achievement and one that will enable us to bring new implant hearing technology with exceptional sound quality, enhanced aesthetics, user friendliness and reliability to more patients than ever before.” Oticon Medical is part of the Demant group, a global player in hearing healthcare with more than 16,500 people in more than 30 countries. The company is engaged in providing bone anchored implant solutions to patients with conductive and mixed hearing loss and single-sided deafness in the US.