A prospective multicenter clinical feasibility study of a new automatic speaking valve for postlaryngectomy voice rehabilitation.

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.
Competing Interests: Compliance with ethical standardsConflict of interestThe Netherlands Cancer Institute received a research grant from Atos Medical, Hörby, Sweden, which contributed to the existing infrastructure for health-related quality of life research of the Department of Head and Neck Oncology and Surgery. The University Medical Center Groningen also receives a research grant from Atos Medical, Hörby, Sweden. The manufacturer provided the FlexiVoice devices to the patients at no charge.Research involving human participants and/or animalsThe study was performed according to the protocol approved by the institutional review boards (Protocol M14VOX).Informed consentSigned informed consent was obtained from all participants.