Improving hands-free speech rehabilitation in laryngectomized patients – proof-of-concept of a novel intratracheal fixation device

Permanent hands-free speech with the use of an automatic speaking valve (ASV) is regarded as the optimal voice rehabilitation after total laryngectomy. Due to fixation problems, regular ASV use in patients with a laryngectomy is limited. We have developed an intratracheal fixation device (ITFD) composed of an intratracheal button augmented by hydrophilic foam around its shaft. This study evaluates the short-term effectiveness and experienced comfort of this ITFD during hands-free speech in 7 participants with a laryngectomy. We found that 4 of 7 participants had secure ASV fixation inside the tracheostoma during hands-free speech for at least 30 minutes with the ITFD. The ITFD’s comfort was perceived positively overall. The insertion was perceived as being mildly uncomfortable but not painful. This proof-of-concept study demonstrates the feasibility of the ITFD that might improve stomal attachment of ASVs, and it provides the basis for further development toward a prototype suitable for long-term daily use.