Acceptance of a New Voice Prosthesis | 207 8 concept of a fluoroplastic valve flap and valve seat was expected to prevent biofilm formation and therefore a longer device lifetime. The main reason for leakage however seems to be food residue on the valve or valve seat. However this needs further study as this is not investigated before in other VPs. This study indirectly confirms that the magnet in the ActiValves are probably the key component in their longer device lifetime13. Our cohort included two patients that displaced their PVHP due to brushing. Despite the fact that brushing and lubricant are widely used in VPs such as the ActiValve13, 14, the percentage of such displacements in our clinic, and also in the literature is unknown. One of the two participants has a relatively wide and fragile tracheo-oesophageal fistula, which could potentially be the underlying cause of displacement. For the other participant the cause of the brush-out remains unclear. Investigating and developing new voice prostheses is quite challenging due to the small number of laryngectomized patients and multifactorial issues determining device lifetime. In vitro research of VPs has shown to be useful for investigating the composition and prevention of biofilm formation24, 25. But this leaves out all other factors, such as cleaning of the VP, diet, reflux, pressure in neopharynx and stoma problems. To investigate the quality and device lifetime of a VP, a large cohort of patient is needed to give a valid overview of the device lifetime in vivo. The search for a new voice prosthesis with a longer device lifetime is needed to improve patient acceptance and increase quality of life for these patients, but this remains a great challenge. Limitations This is a feasibility study, investigating acceptance of a new voice prosthesis, and only the rating of the voice recordings was blinded. It was not powered in finding differences between VPs. Due to the limited sample size it is hard to draw definitive conclusions on voice quality and device lifetime. Acceptance of a voice prosthesis is a complex outcome measure associated with many other factors such as stickiness of the valve flap and device lifetime.
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