Clinical evaluation of a membrane-based voice-producing element for laryngectomized women.

BACKGROUND A newly developed artificial voice source was clinically evaluated in laryngectomized women for voice quality improvements. The prosthesis was placed in a commercially available, tracheoesophageal shunt valve. METHODS In 17 subjects, voice-producing element (VPE) prototypes were compared with the subject's regular tracheo-esophageal shunt voice in a randomized cross-over trial. The evaluation was based on aeroacoustic measurements and perceptual analysis. RESULTS Considerably higher fundamental frequencies were attained with the use of the VPE. The sound pressure level also increased for most subjects. The required driving pressures of the lung and air flow rates were altered, allowing significantly longer phonation times in 1 breath. Accumulation of mucus did not interfere with the proper functioning of the device during these tests. CONCLUSION A VPE with sound-generating membranes is suitable for providing a substitute voice source for laryngectomized patients, especially patients suggestive of a severely hypotonic or atonic pharyngoesophageal segment who can benefit from a more melodious and louder voice.