FDA.reportPublic FDA data

Voice amplification system

Definition
An assembly of battery-powered, personal-worn, devices designed to amplify the loudness of the voice of a person with reduced vocal capacity (e.g., due to impairment of throat or chest muscles, partial paralysis of vocal cords, diminished lung capacity). It typically includes a dedicated microphone, an electronic amplifier, and a loudspeaker. Assemblies with special adaptors that are intended for use with an artificial larynx, a transoesophageal puncture tube, and/or other prostheses or implants are available. Some amplifiers are available as an integral part of an artificial larynx.
GUDID devices
26
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
B792FGN002SPEAX PatchATAIA INC.FGN-0022020-03-09
00860009460508RometFountain Head Marketing Inc.R1202023-11-15
00860009460515RometFountain Head Marketing Inc.R2102023-11-15
00860009460522RometFountain Head Marketing Inc.R3102023-11-15
00860009460539RometFountain Head Marketing Inc.R7002023-11-15
00860009460546RometFountain Head Marketing Inc.R6002023-11-15
00860009460591Blom-SingerFountain Head Marketing Inc.EL 20002023-11-15
04961333254309MULTI-SPEECHPENTAX OF AMERICA, INC.3706-12023-08-25
B792FGN010SPEAX Patch for Home UseATAIA INC.FGN-0102022-01-26
B792FGN011SPEAX Digital Communication System for Home UseATAIA INC.FGN-0112022-01-26
B792FGN009SPEAX Digital Communicator Subscription PackageATAIA INC.FGN-0092022-01-20
B792FGN008SPEAX Digital Communicator Trial PackageATAIA INC.FGN-0082021-10-08
B792FGN007SPEAX Digital CommunicatorATAIA INC.FGN-0072021-07-05
B792FGN001SPEAX CommunicatorATAIA INC.FGN-0012020-03-09
B792FGN003SPEAX PatchATAIA INC.FGN-0022020-03-09
B792FGN004SPEAX Starter PackageATAIA INC.FGN-0042020-03-09
B792FGN006SPEAX Trial PackageATAIA INC.FGN-0062020-03-09
04961333229666N/APENTAX OF AMERICA, INC.43022017-04-05
04961333229710N/APENTAX OF AMERICA, INC.43452017-04-05
04961333230006MULTI-SPEECHPENTAX OF AMERICA, INC.37062017-04-06
04961333230013MULTI-SPEECHPENTAX OF AMERICA, INC.37092017-04-06
04961333230471n/aPENTAX OF AMERICA, INC.7182-45002017-04-05
04961333231133SHUREPENTAX OF AMERICA, INC.0260-00182017-04-07
04961333231522PHONATORY AERODYNAMIC SYSTEMPENTAX OF AMERICA, INC.7188-98002017-04-05
04961333242009N/APENTAX OF AMERICA, INC.7175-60002018-03-06
04961333245192N/APENTAX OF AMERICA, INC.7190-53002018-04-03