title: A prospective multicenter clinical feasibility study of a new automatic speaking valve for postlaryngectomy voice rehabilitation.
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.
authors.affiliation: Department of Head and Neck Oncology and Surgery, Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands.
authors.forename: L
authors.initials: L
authors.lastname: Lansaat
authors.affiliation: Department of Otorhinolaryngology-Head and Neck Surgery, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
authors.forename: B J
authors.initials: BJ
authors.lastname: de Kleijn
authors.affiliation: Department of Head and Neck Oncology and Surgery, Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands. f.hilgers@nki.nl.|Department of Maxillofacial Surgery, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands. f.hilgers@nki.nl.
authors.forename: F J M
authors.initials: FJ
authors.lastname: Hilgers
authors.affiliation: Department of Otorhinolaryngology-Head and Neck Surgery, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
authors.forename: B F A M
authors.initials: BF
authors.lastname: van der Laan
authors.affiliation: Department of Head and Neck Oncology and Surgery, Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands.|Institute of Phonetic Sciences (ACLC), University of Amsterdam, Amsterdam, The Netherlands.|Department of Maxillofacial Surgery, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
authors.forename: M W M
authors.initials: MW
authors.lastname: van den Brekel
mesh_terms: D005240:Feasibility Studies; D005260:Female; D006801:Humans; D007825:Laryngectomy / Q000534:rehabilitation*; D007831:Larynx, Artificial; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D011446:Prospective Studies; D011474:Prosthesis Design; D011788:Quality of Life; D013060:Speech / Q000502:physiology*; D013071:Speech, Alaryngeal / Q000379:methods*
keywords: Automatic speaking valve; Compliance; Heat and moisture exchanger; Total laryngectomy; Voice