HEALTH

iHEAR Medical, Atlazo pair on hearables product development

BY Michael Johnsen

iHEAR Medical, a provider of direct-to-consumer and OTC hearing solutions, on Tuesday partnered with Atlazo to develop an advanced digital hardware platform to power iHEAR’s next generation of hearing aids and hearables. The ultra-low power System on Chip platform will offer machine learning, analytics, connectivity and integrated power management capabilities enabling unprecedented energy efficiency, size reduction and cost savings.

The digital hardware platform is designed to power a new Hearing of Things standard offering real-time health tracking, voice commands and seamless connectivity to other smart devices, including mobile phones and home appliances.

“iHEAR’s technology and IP will expand the hearing aid market and lead the emerging hearables market,” John Luna, COO of San Leandro, Calif.-based iHEAR. “The collaboration with Atlazo and the HoT standard will accelerate the growth of hearables devices market expected to reach $23 billion by 2023.”

The Hearing of Things operating system intends to shift personal computing and devices from reliance on traditional visual displays to the auditory domain, offering direct communications into the ear with complete privacy and reduced distraction. Consumers will be able to selectively listen to and send communications to their social media and text messages using hearing devices instead of their cell phone or computer, eliminating the need to be tethered to traditional computing devices for sending and receiving information.

“Consumers will not only benefit from improved hearing in challenging listening situations, but also from more natural interactions with smart devices compared to traditional methods of visual and touch-based user interfaces,” Adnan Shennib, CEO of iHEAR Medical, said.

The new HoT standard will offer bi-directional wireless connectivity to everyday devices, from mobile phones to home appliances. Hearing devices powered by HoT OS will streamline the user experience for mobile phone functionality, including phone calling and control of home appliances, with a voice user interface. In addition, HoT devices will monitor and relay personal and health information into the ear privately and discreetly. iHEAR Medical and Atlazo have 19 pending and issued patents for the HoT standard, targeting smart hearing devices.

Atlazo will design and manufacture the highly integrated single-chip hardware. “We are pleased to join forces with iHEAR Medical to develop intelligent ultra-lower power SoC solutions for hearing aids and hearables, leveraging iHEAR’s extensive domain experience in hearing health,” Karim Arabi, CEO Atlazo, said. “We see our collaboration with iHEAR as a first step towards entering the broader market of consumer health and fitness to enable connected digital health.”

The World Health Organization estimates 5% of the world’s population, or approximately 360 million people, suffer from a disabling level of hearing loss. While 95% of those with hearing loss can be readily treated with a hearing aid, less than 10% of them use one. Hearing loss has become increasingly prevalent in the U.S., and is now the third most common health problem after heart disease and arthritis. With the average cost of hearing aids reaching $5,000 for a pair, only 14% of Americans with hearing loss currently own a hearing aid due to excessive cost and limited access to hearing care.

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SPINS bolsters insight leadership through three new presidents

BY Michael Johnsen

SPINS, a Chicago-based source in health and wellness retail intelligence, last week made a number of executive announcements, including the hiring of a new president retail applications, a new president of product library solutions and the promotion of a long-time SPINS veteran to president client growth solutions.

Timothy Alvis is joining SPINS as president of retail applications, where his chief focus will be to help retailers build and strengthen relationships with both their vendor partners and their shoppers through GroceryPress, a consumer engagement platform built for today’s health and wellness marketplace, and other digital applications. Prior to joining SPINS, Alvis spent 18 years leading successful initiatives and driving products to market with Amazon and Microsoft.

“Timothy Alvis understands the new digital marketplace and the types of products and solutions that are necessary for retailers to compete,” Tony Olson, SPINS CEO, said. “SPINS is excited to bring the wealth of knowledge Tim gained at Microsoft and Amazon to SPINS’ retail and brand partners in order to grow a consumer base aligned with our mission to increase access to health and wellness products and to help them to live more vibrant lives.”

Meanwhile, Irina Mazur joins SPINS as president product library solutions, where she will connect SPINS clients and partners to deeper insights unlocked by the company’s proprietary market segmentation and product attribution. Her previous experience spans traditional retail, e-commerce, digital media, software development, product management and technical program management. Over 20 years, she has elevated solutions experiences with companies such as ShopperTrak Retail Traffic and Behavior Analytics, Tyco Retail and Mall Solutions, and Label Insight, where she was most recently chief product officer.

And Anubhav Goel has been elevated to president of client growth solutions, SPINS. In his prior executive vice president role, Goel led and grew SPINS’ Brand Growth Solutions, Consumer Insight Solutions and Financial Partners Group.

Brand Growth Solutions is a leading strategy consulting boutique for the Natural Products Industry, working with more than 100 of SPINS’ brand clients on sales and marketing growth strategies. Consumer Insight Solutions enables insights into the natural and organic consumer using the National Consumer Panel, concept testing and primary research solutions. And Goel’s newest division, SPINS’ Financial Partners Group, offers unique solutions to help investors find, analyze and invest in winning health and wellness brands.

Goel’s promotion empowers him to more nimbly drive transformative solutions and applications for SPINS’ clients and partners, with full authority over engineering, product development and commercialization in this area of SPINS’ business.

“Anu launched the Client Growth Solutions business three years ago with the mission to bring the best of SPINS to our clients and to help them grow in brand new ways,” Olson said. “Under his leadership, this team has worked with many of our clients – brands, investors, and retailers – who have all derived unique value from our exciting strategy consulting, consumer insights, and investment solutions. SPINS is proud to continue investing in customized solutions for our clients and partners through Anu’s promotion to president and more best-in-class capabilities from our Client Growth Solutions team.”

 

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Congress seeks to update OTC monograph system

BY Michael Johnsen

Rep. Bob Latta, R-Ohio, on Monday introduced bipartisan legislation along with members of the Energy and Commerce Committee to reform the outdated over-the-counter monograph system. The legislation, the Over-the-Counter Monograph Safety, Innovation, and Reform Act, modernizes the monograph framework and allows new, safe products to come to market more quickly while addressing safety issues and expanding consumer choice.

“While the OTC Monograph system is a smart, balanced framework for regulating OTC medicines containing ingredients with a proven history of safe use and efficacy, it relies on notice and comment rulemaking which has become an increasingly slow and unresponsive administrative process,” Scott Melville, president and CEO for the Consumer Healthfare Products Association, said. “As a result, the Monograph system has become cumbersome and, essentially, has ground to a halt. Today, it can take several years or more to update product labels with new safety information, approve new ingredients or make other important changes for consumers. Moreover, the current system does not provide a mechanism for innovation.”

“Nearly every American uses over-the-counter products in some way,” Latta said. “It’s time to create a pathway for industry to enhance over-the-counter medicines and develop new, innovative products that will be a welcome addition to the current products so many Americans depend on today. By modernizing the decades-old monograph system and improving the way OTC drugs are approved, this bill will provide more certainty for manufacturers, ensure consumer confidence and foster innovation.”

The new bill would allow the Food and Drug Administration to make scientific determinations for OTC ingredients through an administrative order process, which is much more efficient than the current rulemaking system. The current system has not had a significant update since 1972.

“With more than 300,000 over-the-counter products on the market, that is far too long to wait,” Rep. Michael Burgess, R-Texas, said. “The bill introduced today will ensure that American development remains at the helm of over-the-counter drug innovation. I am grateful to Congressman Latta for his leadership on this issue, and I look forward to bringing our over-the-counter monograph system into the 21st century.”

Introducing the legislation with Latta and Burgess are Reps. Gene Green, D-Texas, Diana DeGette, D-Colo., Brett Guthrie, R-Ky., and Debbie Dingell, D-Mich.

“Over-the-counter drugs provide an affordable way for Americans to seek medical treatment,” Guthrie said. “Unfortunately, the current FDA approval process for over-the-counter products is too slow, delaying important innovations that can help patients more quickly.”

The OTC monograph system was established in 1972 by FDA to review the safety and efficacy of the OTC medicine ingredients then on the market, including doses, formulations and labeling. Any OTC that conforms to a monograph may be manufactured and sold without an individual product approval. In the 45 years since the system was created, the process has not been completed and movement on unfinished items has been slow. The system has become a hindrance that does not allow for advances in science and new information concerning the safety of an ingredient.

The draft legislation updates the monograph process by specifically adding a new section to the Food, Drug, and Cosmetic Act to:

  • Move away from the cumbersome current monograph finalization process to an administrative order procedure. Additional processes will be in place to ensure recourse should issues arise;
  • Create new pathways to innovation for monograph products benefiting consumers, where none currently exits;
  • Ensure the new drug approval pathway and other nonprescription drugs otherwise lawfully marketed are not affected; and
  • Include by reference existing OTC Review Final Monographs and deem final Tentative Final Monographs by statute.

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