In order to improve voice quality in female laryngectomees and/or laryngectomees with a hypotonic pharyngo-oesophageal segment, a sound-producing voice prosthesis was designed. The new source of voice consists of either one or two bent silicone lips which perform an oscillatory movement driven by the expired pulmonary air that flows along the outward-striking lips through the tracheo-oesophageal shunt valve. Four different prototypes of this pneumatic sound source were evaluated in vitro and in two female laryngectomees, testing the feasibility and characteristics of this new mechanism for alternative alaryngeal voice production. In vivo evaluation included acoustic analyses of both sustained vowels and read-aloud prose, videofluoroscopy, speech rate, and registration of tracheal phonatory pressure and vocal intensity. The mechanism proved feasible and did not result in unacceptable airflow resistance. The average pitch of voice increased and clarity improved in female laryngectomees. Pitch regulation of this prosthetic voice is possible with sufficient modulation to avoid monotony. The quality of voice attained through the sound-producing voice prostheses depends on a patient's ability to let pulmonary air flow easily through the pharyngo-oesophageal segment without evoking the low-frequency mucosal vibrations that form the regular tracheo-oesophageal shunt voice. These initial experimental and clinical results provide directions for the future development of sound-producing voice prostheses. A single relatively long lip in a container with a rectangular lumen that hardly protrudes from the voice prosthesis may have the most promising characteristics.