Acceptance of a New Voice Prosthesis | 193 8 Introduction After total laryngectomy (TL), restoration of voice is an essential goal of rehabilitation. Due to a more intelligible speech and better voice quality, trachea-esophageal speech (TES) using voice prostheses (VP) has become the gold standard in the Western World1, 2. VPs have a limited device lifetime and need to be replaced regularly, on average between two to six months, depending on the VP type3, 4. The most common reason for replacement is leakage through the VP due to malfunction of the valve, called transprosthetic leakage5-8. A major problem is that the device lifetime is unpredictable and varies enormously9. This leads to patients often experiencing issues with voice prostheses for which they need to visit a hospital, which demands a lot of healthcare workers10. Most patients use VPs such as the Provox Vega (Atos Medical AB, Hörby, Sweden) or the Blom-Singer Classic (InHealth Technologies, Carpinteria, CA). There are also problem-solving VPs available which can be used for problems such as underpressure, early leakage or fistula widening, causing periprosthetic leakage11. An example is the Provox ActiValve which has a valve made of fluoroplastic with a built-in magnet for optimal closure, and has proven to have a longer device lifetime (median > eleven months)9, 11. However, the ActiValve is costly in comparison to other VPs, and therefore not available for most patients due to reimbursement issues. A more affordable VP with a predictable and prolonged device lifetime would be of added value to the current market. Therefore, Atos Medical AB developed the Provox Vega High Performance (PVHP). The PVHP is made of silicon rubber with a fluoroplastic valve flap and valve seat, a material that resists biofilm destruction similar as in ActiValve12, but without the use of a valve magnet. Fluoroplastic is a sticky material, for which the use of a lubricant is needed to prevent blockage of speech13, 14. The aim of this study was to investigate patient acceptance of the PVHP. Secondary outcomes were experienced stickiness of the valve, effort to speak, subjective and objective voice quality and device lifetime.
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