Abstract
Evaluation of short- and long-term clinical feasibility and exploration of limitations and advantages of a new automatic speaking valve (ASV) for laryngectomized patients with integrated HME, the Provox FreeHands FlexiVoice (FlexiVoice). This ASV not only enables automatic, but also manual closure of the valve. A multicenter, prospective clinical study in 40 laryngectomized patients was conducted. Participants were asked to use the FlexiVoice for 26 weeks. The primary outcome measure was long-term compliance. Secondary outcome measures were: patient preference, hours of FlexiVoice use, device life of adhesive, voice and speech quality, and quality of life. After 26 weeks, 15 patients (37.5 %) were using the FlexiVoice on a daily basis, for a mean of 12.64 h/day (SD ± 5.03). Ten patients (25 %) were using the device on a non-daily basis, for a mean of 3.76 h/day (SD ± 2.07). The remaining 15 patients (37.5 %) discontinued using the FlexiVoice. Sixty percent of the 25 long-term users applied both automatic and manual closure of the valve. Unpredictable fixation of the adhesive was the main reason for discontinuing or not using the FlexiVoice on a daily basis. Overall, 18 patients (45 %) preferred the FlexiVoice, 16 patients (40 %) their usual HME, 3 patients (7.5 %) their usual ASV, 1 patient (2.5 %) preferred no device at all, and in 2 patients preference was not recorded. The minor technical issues identified could be corrected. The Provox FreeHands FlexiVoice appears to be a useful ASV, which allows for hands-free speech in a larger proportion of laryngectomized patients in the present cohort. The additional manual closure option of the device is beneficial for maintaining the adhesive seal longer.
Highlights
The daily use of hands-free speech in this cohort increased from 20 % (8/40) at baseline to 37.5 % (15/40) at 26 weeks follow-up, with 10 of the original 13 FreeHands users switching to the new FlexiVoice
Besides the original five non-daily FreeHands users, there were five additional non-daily users for a total of ten patients (12.5 % at baseline compared to 25 % at 26 weeks), who used/converted to the new FlexiVoice device
For almost two-thirds of the patients, the FlexiVoice is a valuable option, whereas one-third of the patients remain fully dependent on finger occlusion
Summary
Airtight stoma occlusion has become easier after the development of specialized HMEs, which improve maximum phonation time and dynamic loudness range and compliance rate [6] With these HMEs, it is still necessary to use a finger to occlude the stoma for speech production. To further improve patient friendliness and compliance of automatic speech, a new automatic speaking valve was developed, the Provox FreeHands FlexiVoice (further called FlexiVoice; Atos Medical AB, Horby, Sweden). This new ASV contains a renewed mechanism to lock and unlock the speaking membrane. The objective of this prospective clinical study is to evaluate the short- and long-term feasibility of the FlexiVoice, in combination with the currently available attachments, and to explore its limitations and advantages
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