Performance of the SPIRION Laryngeal Pacemaker in BVFP Patients Without Glottal Enlargement

General information The following patient categories can be recruited into this clinical investigation if they comply with all the selection criteria: * Patients recruited in the previous first-in-human (FIH) clinical investigation 2011CIP001 * Patients with an open tracheostoma at the time of enrolment Inclusion Criteria: * Between 18 and 75 years old at the time of enrolment (i.e., informed consent form (ICF) signed) * Diagnosed with BVFP for a minimum of 6 months * With sufficient autonomous respiratory capacity to maintain their vital functions independently of the SPIRION Laryngeal Pacemaker. Before a permanent closure of the tracheostomy is carried out during this clinical investigation, the Principal Investigator shall confirm that at least at rest, the failure of the SPIRION Laryngeal Pacemaker would not put the patient in a life-threatening condition because of insufficient respiratory patency * At least one PCA responds to electrical stimulation (clear abduction of the respective VF in response to electrical stimulation) within an Endoscopic Cap Electrode (ECE50) test * Fluent in German. Exclusion Criteria: * Lack of compliance with any inclusion criteria * Pregnant or breast-feeding women * Patients suffering from an ongoing or chronic laryngeal inflammation at the time of enrolment * Vocal fold immobility caused by arytenoid joint dysfunctions (e.g., arthritis, scarring, etc.), malignancies, central nervous system (CNS) pathologies, and/or systemic diseases …