InHealth Technologies, manufacturer of Blom-Singer voice restoration and ENT products and a business unit of Freudenberg Medical, has launched the Blom-Singer SpeakFree HME hands-free valve created for people who have had total laryngectomy.
A total laryngectomy is surgery 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 to speak. Daily disposable HME, SpeakFree enables hands-free speech for people with a tracheoesophageal puncture and voice prosthesis. The product is adjustable to suit an individual’s activity and offers the option of choosing between hands-free or digital occlusion.
Bethany Anke, Vice President and General Manager of InHealth Technologies, said, âThis product is game-changing and demonstrates InHealth’s commitment to continuous innovation and laryngectomy care. As a licensed speech-language pathologist, I have witnessed the market‘s need for a more accessible and affordable single-use disposable device. We are delighted with the positive feedback we have received from customers during product testing.
Hands-free speaking dramatically improves the quality of life for laryngectomy clients worldwide, who can now speak without manually activating a talking device. InHealth’s latest product innovation allows laryngectomy patients to speak while both hands are engaged.
The engineering teams of InHealth and Freudenberg Medical worked together on all aspects – from product design and prototyping to mold design, mass production and assembly. Computer simulation and finite element analysis were used to model device performance and guide the design of critical components. 3D printing and design for manufacturing have been used to speed up design iterations and the production cycle. High volume production of the device involves advanced injection molding with in-process visual inspection, unique robotic part manipulation, and automated assembly processes with tight tolerance precision.
Max Gisbert Kley, CEO of Freudenberg Medical, said: âThe SpeakFree HME is a radical innovation for patients and a breakthrough technical achievement. By combining InHealth’s world-class product development expertise with the advanced treatment capabilities of Freudenberg Medical, we aim to set a new standard for accelerating medical device innovation in the laryngectomy field.