APrevent-VOIS-Implant-002 - a Two-Part, Open-Label, Non-Randomized Multicenter Study

Inclusion Criteria:

• Male and female patients between 18 and 80 years

• Diagnosed with permanent UVFP and insufficient glottal closure

• A significant voice disorder as measured by perceptual rating (Grade ≥2 GRBAS Scale)and Voice Handicap Index (VHI-30 score >33)

• Ability to comprehend the full nature and purpose of the study, including possiblerisks and side effects

• Ability to co-operate with the Investigator and to comply with the requirements ofthe entire study

• Availability to volunteer for the entire study duration, willing to adhere to allprotocol requirements and willing and able to give informed consent forparticipation

Exclusion Criteria:

• Any other significant disease or disorder which, in the opinion of the investigator,may either put the participant at risk because of participation in the clinicalinvestigation may influence the result of the clinical investigation, or theparticipant's ability to participate in the clinical investigation

• Scheduled elective surgery or other procedures requiring general anaesthesia duringclinical investigation

• Bilateral vocal fold paralysis

• Had injection medialization laryngoplasty with the injectable still being within thedouble length of the maximum resorption time frame as stated in their approval or assupported by literature.

• Presence of structural vocal fold lesions such as polyp or nodules

• Presence of oropharyngeal or laryngeal tumors

• Patients with diagnosed severe obstructive sleep apnea (OSA)

• Status post total cordectomy

• Previous laryngeal framework surgery (any type of thyroplasty, arytenoid adduction)

• Status post tracheostomy

• Presence of acute systemic infection at time of screening or shortly before surgery

• Significant non-laryngeal speech abnormality (severe dysarthria determined by apanel of trained speech therapists)

• Severe coagulopathy

• Females who are pregnant, lactating or planning pregnancy are excluded from theinvestigation

• Patients with bil. Gr. III-IV hypertrophic tonsils

• Diabetes mellitus with poor control and poor wound healing history