FDA.reportPublic FDA data

Transcervical artificial larynx

Definition
A battery-powered, speech-assistive device designed to be used by a person who has had their larynx removed (laryngectomy) to assist them in the reproduction of sounds similar to those produced by the vocal cords in normal speech. It is an externally-applied electromechanical device (also known as a neck-type artificial larynx) with a plastic or metal probe that generates a sound (i.e., tone); when the probe is held against the tissues of the neck (or cheek) the tone is transmitted to the mouth through the oropharynx. The appropriate movement of the lips, tongue, teeth, and jaw converts the tone into meaningful speech (i.e., modulates the tone).
GUDID devices
62
Last updated
2026-06-18 06:05:16

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00860012896806Parlez ElectrolarynxElogio Speech Technologies LLCParlez2026-06-09
00860012896875Parlez ElectrolarynxElogio Speech Technologies LLCParlez XL2026-06-09
00813124010738TruTone Plus® ElectrolarynxGRIFFIN LABORATORIESK1202020-08-24
00813124010974TruTone Plus® ElectrolarynxGRIFFIN LABORATORIESKD1202020-08-24
10850057368014Blom-SingerEnt Solutions LLCEL 10012023-12-18
10850057368021Blom-SingerEnt Solutions LLCEL 10022023-12-18
10850057368038Blom-SingerEnt Solutions LLCEL 10042023-12-18
00860013939038AVA Voice 90 Day KitLARONIX PTY LTD2.02025-11-11
00860013939045AVA Voice Trial KitLARONIX PTY LTD2.02025-11-11
00860013939007AVA Voice 90 Day KitLARONIX PTY LTD1.02025-05-15
00860013939014AVA Voice Trial KitLARONIX PTY LTD1.02025-05-15
00860013939021AVA Voice Membrane PackLARONIX PTY LTD1.02025-05-15
10850057368007Blom-SingerEnt Solutions LLCEL 10002023-12-18
20850057368011Blom-SingerEnt Solutions LLCEL 10012023-12-18
20850057368028Blom-SingerEnt Solutions LLCEL 10022023-12-18
20850057368035Blom-SingerEnt Solutions LLCEL 10042023-12-18
07331791015571Provox TruTone PlusAtos Medical AB74442022-07-08
07331791015823Provox SolaTone PlusAtos Medical AB74382022-07-08
07331791015830Provox TruTone EmoteAtos Medical AB74392022-07-08
04040823006502SERVOX digital XLServona GmbH375752021-02-18
00813124010981TruTone Plus® ElectrolarynxGRIFFIN LABORATORIES74442021-02-05
00813124010011TruTone® ElectrolarynxGRIFFIN LABORATORIESK1012019-07-23
00813124010356TruTone® ElectrolarynxGRIFFIN LABORATORIESK1362019-07-23
00813124010868TeliTalk™ ElectrolarynxGRIFFIN LABORATORIESK5200BT-FTRI2020-03-17
00813124010875TeliTalk™ ElectrolarynxGRIFFIN LABORATORIESK5200LL-FTRI2020-03-17
00813124010004TruTone® ElectrolarynxGRIFFIN LABORATORIESK1522019-10-23
00813124010035SolaTone® ElectrolarynxGRIFFIN LABORATORIESK2062019-10-23
00813124010097TruTone® ElectrolarynxGRIFFIN LABORATORIESKD1362019-10-23
00813124010103SolaTone Plus™ ElectrolarynxGRIFFIN LABORATORIESKD3552019-10-23
00813124010110SolaTone Lite® ElectrolarynxGRIFFIN LABORATORIESK3502019-10-23
00813124010127SolaTone Plus™ ElectrolarynxGRIFFIN LABORATORIESK3552019-10-23
00813124010134TruTone Plus® ElectrolarynxGRIFFIN LABORATORIESK1202019-10-23
00813124010141TruTone EMOTE® ElectrolarynxGRIFFIN LABORATORIESK10002019-10-23
00813124010158TruTone EMOTE® ElectrolarynxGRIFFIN LABORATORIES74392019-10-23
00813124010165SolaTone Plus™ ElectrolarynxGRIFFIN LABORATORIESK220-BRAZIL2019-10-23
00813124010172SolaTone Plus™ ElectrolarynxGRIFFIN LABORATORIES74382019-10-23
00813124010189TruTone EMOTE® ElectrolarynxGRIFFIN LABORATORIESK1000-CAN2019-10-23
00813124010196TruTone EMOTE® ElectrolarynxGRIFFIN LABORATORIESK13002019-10-23
00813124010202TruTone Plus® ElectrolarynxGRIFFIN LABORATORIESK360-22019-10-23
00813124010219TruTone Plus® ElectrolarynxGRIFFIN LABORATORIESKD1202019-10-23
00813124010226TruTone® ElectrolarynxGRIFFIN LABORATORIESK1502019-10-23
00813124010233TruTone® ElectrolarynxGRIFFIN LABORATORIESK1512019-10-23
00813124010240SolaTone® ElectrolarynxGRIFFIN LABORATORIESK2502019-10-23
00813124010257SolaTone® ElectrolarynxGRIFFIN LABORATORIESK2512019-10-23
00813124010264SolaTone® ElectrolarynxGRIFFIN LABORATORIESK2762019-10-23
00813124010271SolaTone® ElectrolarynxGRIFFIN LABORATORIESK2802019-10-23
00813124010288SolaTone® ElectrolarynxGRIFFIN LABORATORIESKD2262019-10-23
00813124010295SolaTone Plus™ ElectrolarynxGRIFFIN LABORATORIESK355-12019-10-23
00813124010301SolaTone Plus™ ElectrolarynxGRIFFIN LABORATORIESK355-CAN2019-10-23
00813124010318Liberty® ElectrolarynxGRIFFIN LABORATORIESK3062019-10-23
00813124010325TruTone EMOTE® ElectrolarynxGRIFFIN LABORATORIESK10522019-10-23
00813124010332TeliTalk™ ElectrolarynxGRIFFIN LABORATORIESK5200BT2019-10-23
00813124010349TeliTalk™ ElectrolarynxGRIFFIN LABORATORIESK5200LL2019-10-23
00813124010363TruTone Plus® ElectrolarynxGRIFFIN LABORATORIESK1212019-10-23
00813124010370SolaTone Lite® ElectrolarynxGRIFFIN LABORATORIESK3022019-10-23
00813124010387TruTone EMOTE® ElectrolarynxGRIFFIN LABORATORIESKD10002019-10-23
00817126020979Atos Medical Inc.ATOS MEDICAL INC.2010-0722019-09-25
00848253003436InHealth Technologies; Blom-SingerFreudenberg Medical, LLCPK 21042019-06-07
00817126020542Atos Medical ATOS MEDICAL INC.12/552017-11-11
00817126020573Atos MedicalATOS MEDICAL INC.2010-41E62017-11-28
00817126020597Atos MedicalATOS MEDICAL INC.2010-0552017-12-12
00817126020603Atos MedicalATOS MEDICAL INC.9/362017-12-12