Tracheoesophageal speech valve, indwelling, non-sterile

A tracheoesophageal speech valve, indwelling, non-sterile is a medical device designed to restore voice after total laryngectomy by being placed into a surgically created tracheoesophageal fistula. It allows air from the lungs to pass into the esophagus during speech, producing sound for communication, while its one-way valve prevents aspiration during swallowing by closing under negative pressure and opening under positive airflow.

This category of device is intended for single use and is supplied in a non-sterile condition, requiring cleaning by the user in situ with optional assistive tools like brushes. It is inserted and replaced by a healthcare professional as needed, and its dual-flange design ensures secure placement within the fistula tract. Regulation of such devices focuses on their mechanical function and biocompatibility, with classification based on their intended use and risk profile as defined by relevant authorities.