Freudenberg Medical today announced the commercial launch of its Blom-Singer SpeakFree heat and moisture exchange (HME) hands free valve.

The device is designed for people who have undergone a total laryngectomy, or the removal of a person’s larynx or voice box, resulting in loss of speech.

Carpinteria, California-based Freudenberg Medical’s InHealth Technologies unit said its SpeakFree HME is the first single-use HME cartridge with an adjustable valve that does not require manual closure to speak, enabling hands-free speech for individuals with a tracheoesophageal puncture and voice prosthesis. The daily disposable product is adjustable for an individual’s activity and offers flexibility of hands-free and 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, in a news release. “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.”

InHealth and Freudenberg Medical said their engineering teams partnered on product design, prototyping, mold design, serial manufacturing, and assembly. They used computer simulation and finite element analysis to model the performance of the device and guide the design of critical components, and used 3D printing and design for manufacturing 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, according to the news release.

Freudenberg Medical CEO Max Gisbert Kley called the SpeakFree HME “a radical innovation for patients and a groundbreaking technical achievement.”

“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,” he said in the news release.