Safety and Efficacy of the Swallow Expansion Device (SED) for Improvement of Swallowing in Patients

Inclusion Criteria: * Profound oropharyngeal feeding tube dependent dysphagia of greater than 12 months duration, as documented by the prevalence of aspiration on fluoroscopic swallow study. * Must be receiving 100% of nutritional requirements by enterogastric tube. * 18 years of age and older, acceptable forms of documentation for verification of age include birth certificate, passport, and/or driver's license. * Diminished upper esophageal sphincter opening defined as less than .55 cm for individuals under 65 years of age and less than .40 cm for individuals over 65 years of age on fluoroscopic swallow study. * Failure of \> 3 months of dysphagia therapy within 3 months of study enrollment. * No documented history of noncompliance with feeding recommendations. * Cognition that is within normal limits, as evidenced by an Abbreviated Mental Test Score (AMTS) score greater than 6. * Manual dexterity that is within normal limits for age, sex, and hand, as evaluated by a Block and Box Test (BBT). * Physical strength to pull the SED forward, as evidenced by the ability to lift a 5 lb weight off of a table and keep it elevated for 10 seconds. * Ability to understand the informed consent and comply with follow-up, as evidenced by appropriate questions, responses, and comments during the initial evaluations and a normal Abbreviated Mental Test Score. * Bilateral vocal fold mobility or unilateral vocal fold immobility in which the individual is able to attain complete glottic closur…