ORIGINAL ARTICLE CLINICAL EVALUATION OF A MEMBRANE-BASED VOICE- PRODUCING ELEMENT FOR LARYNGECTOMIZED WOMEN Johannes W. Tack, PhD, 1 Qingjun Qiu, PhD, 1 Harm K. Schutte, PhD, 1 Piet G. C. Kooijman, PhD, 2 Cees A. Meeuwis, MD, 3 Eduard B. van der Houwen, MSc, 1 Hans F. Mahieu, PhD, 4 Gijsbertus J. Verkerke, PhD 1,5 1 Department of BioMedical Engineering, University Medical Center Groningen, University of Groningen, 9713 AV Groningen, The Netherlands. E-mail: g.j.verkerke@med.umcg.nl 2 Department of ENT, University Medical Centre St. Radboud, Nijmegen, The Netherlands 3 Department of Oto-Rhino-Laryngology, Head and Neck Surgery, Erasmus Medical Centre, Rotterdam, The Netherlands 4 Department of Otorhinolaryngology, VU Medical Centre, Amsterdam, The Netherlands 5 Department of Biomechanical Engineering, University of Twente, Enschede, The Netherlands Accepted 17 January 2008 Published online 18 July 2008 in Wiley InterScience (www.interscience.wiley.com). DOI: 10.1002/hed.20853 Abstract: 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 laryngectom- ized patients, especially patients suggestive of a severely hypo- tonic or atonic pharyngoesophageal segment who can benefit from a more melodious and louder voice. V V C 2008 Wiley Period- icals, Inc. Head Neck 30: 1156–1166, 2008 Keywords: laryngectomy; voice rehabilitation; artificial larynx; voice prosthesis; perceptual voice analysis An established technique for voice rehabilitation after total laryngectomy is the insertion of a 1- way valve in a surgically created tracheoesopha- geal (TE) shunt, enabling the production of a TE voice. 1–3 The TE voice is produced by vibrations of the pharyngoesophageal segment, initiated by a flow of air diverted from the lungs to the esopha- gus. Problems arise, especially for female patients, because of the usually low pitch of the substitute voice. 4–6 Furthermore, for some laryng- ectomized patients, the tonicity of the pharyngo- esophageal segment is too low or even absent, which leads to a breathy TE voice of poor quality. 7,8 Recent studies focused on the development of an artificial voice source that can be placed in com- Correspondence to: G. J. Verkerke Contract grant sponsor: Eureka project Newvoice 2614; Contract grant number: TSIN 1015. V V C 2008 Wiley Periodicals, Inc. 1156 Clinical Evaluation of a Voice-Producing Element HEAD & NECK—DOI 10.1002/hed September 2008