{"entity":{"id":"voice-prostheses","kind":"technology","name":"Voice prostheses after laryngectomy (Provox, Blom-Singer)","aka":["Voice prosthesis","Tracheoesophageal voice prosthesis","Speaking valve","Provox Vega","Provox ActiValve","Blom-Singer"],"tldr":"A small one-way valve fitted between the windpipe and the gullet after the voice box is removed. Covering the breathing hole in the neck sends air through the valve, and the throat vibrates to make a voice.","summary":"The FDA classes voice prostheses as laryngeal prostheses (product code EWL, 21 CFR 874.3730). Atos Medical's clearances include Provox Vega (K090455, 5 June 2009), Provox ActiValve (K092593, 14 October 2010) and the Provox FreeHands FlexiVoice (K141380, 26 September 2014). Helix Medical (InHealth) holds clearances for the Blom-Singer Indwelling 2000 (K991587, 25 June 1999) and Blom-Singer dual valve indwelling prosthesis (K082206, 4 September 2008). The record on voice after laryngectomy covers how the prosthesis is used, why it is changed and why people stop using it.","status":"standard-of-care","asOf":"2026-11-04","links":[{"label":"FDA product code EWL: laryngeal prosthesis","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=EWL"},{"label":"FDA 510(k) K090455: Provox Vega (5 June 2009)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K090455"},{"label":"FDA 510(k) K092593: Provox ActiValve (14 October 2010)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K092593"},{"label":"FDA 510(k) K141380: Provox FreeHands FlexiVoice (26 September 2014)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K141380"},{"label":"FDA 510(k) K991587: Blom-Singer Indwelling 2000 (25 June 1999)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K991587"},{"label":"FDA 510(k) K082206: Blom-Singer dual valve indwelling (4 September 2008)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K082206"}],"tags":["devices-gaps-2026-11"],"related":[],"cancers":["laryngeal-cancer","hypopharyngeal-cancer","head-and-neck"],"sections":["surgery","supportive-care","devices"],"technologies":["rejuv-recon-voice-after-laryngectomy","laryngectomy-stoma-care-devices","rejuv-rehab-assistive-devices"],"targets":[],"drugs":[],"companies":["atos-medical"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo device gap fill (openFDA, accessdata.fda.gov, NICE, NHS Drug Tariff Part IX, FDA, maker and society pages)","editedOn":"2026-11-04"},"principle":"A silicone one-way valve sits in a surgical puncture between the posterior tracheal wall and the oesophagus; occluding the stoma diverts exhaled air through it into the pharynx, whose tissue vibrates to produce voice, while the valve closes to stop food and drink entering the airway.","strengths":["Fluent speech for most people fitted","Indwelling models changed in clinic"],"limitations":["Leakage through or around the valve, often from Candida biofilm","Needs regular replacement by a specialist team"],"since":1999},"route":"/technologies/voice-prostheses/","neighbours":{"cancer":[{"id":"head-and-neck","kind":"cancer","name":"Head and neck squamous cell carcinoma","route":"/cancers/head-and-neck/"},{"id":"hypopharyngeal-cancer","kind":"cancer","name":"Hypopharyngeal cancer","route":"/cancers/hypopharyngeal-cancer/"},{"id":"laryngeal-cancer","kind":"cancer","name":"Laryngeal and hypopharyngeal cancer","route":"/cancers/laryngeal-cancer/"}],"section":[{"id":"devices","kind":"section","name":"Devices & Physical Therapies","route":"/fronts/devices/"},{"id":"supportive-care","kind":"section","name":"Supportive Care & Survivorship","route":"/fronts/supportive-care/"},{"id":"surgery","kind":"section","name":"Surgery & Interventional","route":"/fronts/surgery/"}],"technology":[{"id":"laryngectomy-stoma-care-devices","kind":"technology","name":"Heat and moisture exchangers, laryngectomy tubes and stoma protectors","route":"/technologies/laryngectomy-stoma-care-devices/"},{"id":"rejuv-rehab-assistive-devices","kind":"technology","name":"The devices that do the restoring, and who pays for them","route":"/technologies/rejuv-rehab-assistive-devices/"},{"id":"rejuv-recon-voice-after-laryngectomy","kind":"technology","name":"Voice after the larynx is removed","route":"/technologies/rejuv-recon-voice-after-laryngectomy/"}],"company":[{"id":"atos-medical","kind":"company","name":"Atos Medical","route":"/companies/atos-medical/"}]}}