CARPINTERIA, Calif.– InHealth Technologies, maker of Blom-Singer® voice restoration and ENT products and a business unit of Freudenberg Medical, announces the commercial launch of Blom-Singer® SpeakFree™ HME Hands Free Valve created for people who have undergone a total laryngectomy. A total laryngectomy is a surgical procedure in which the larynx or voice box is removed resulting in loss of speech. SpeakFree™ HME is the first single-use heat and moisture exchange (HME) cartridge with an adjustable valve that does not require manual closure in order to speak. A daily disposable HME, SpeakFree™ enables hands-free speech for individuals with a tracheoesophageal puncture and voice prosthesis. The product is adjustable to match an individual’s activity and offers flexibility to choose between hands free or digital occlusion.
“This product is a game changer and demonstrates InHealth’s commitment to ongoing innovation and laryngectomy care,” said Bethany Anke, Vice President and General Manager of InHealth Technologies. “As a licensed Speech Pathologist, I witnessed firsthand the market need for a more accessible single-use disposable device at an affordable price point. We’re thrilled with the glowing feedback we have received from customers in product trials.”
Hands free speech greatly enhances quality of life for laryngectomy customers worldwide, who now have the opportunity to speak without manual activation of a speaking device. InHealth’s latest product innovation allows post laryngectomy patients to speak while both hands are engaged.
Driven by a passion for innovation, the engineering teams at InHealth and Freudenberg Medical partnered on every aspect – from product design and prototyping to mold design, serial manufacturing, and assembly. Computer simulation and finite element analysis were used to model the performance of the device and guide the design of critical components. 3D printing and design for manufacturing were employed to accelerate design iterations and cycle into production. The high-volume production of the device involves advanced injection molding with in-process visual inspection, unique robotic part handling, and automated assembly processes with tight tolerance precision.
“The SpeakFree™ HME is a radical innovation for patients and a groundbreaking technical achievement,” said Max Gisbert Kley, CEO, Freudenberg Medical. “By combining InHealth’s world-class product development expertise with the advanced processing capabilities of Freudenberg Medical, we aim to set a new standard for accelerating medical device innovation in the laryngectomy field.”
