FDA.reportPublic FDA data

Audiometric/hearing device software

Definition
A software program intended to assist with the evaluation of a patient’s hearing capability and/or evaluate and adjust the settings of a hearing assistive device. It may be used by healthcare professionals in a healthcare facility or by the patient in the home, and intended to be used on a non-medical computerized device (e.g., smartphone, tablet).
GUDID devices
335
Last updated
2026-07-17 22:00:51

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
05714880297492hear.comWs Audiology Usa, Inc.Venture2026-06-26
05714880189308SonyWs Audiology Usa, Inc.Sony | Hearing Control2023-01-20
05714880199420SonyWs Audiology Usa, Inc.Sony | Hearing Control WA2023-08-31
07613389836325DVD Phonak Target 12.0Sonova AG12.0 DVD2026-06-01
07613389836332USB Phonak Target 12.0 USBSonova AG12.0 USB2026-06-01
07613389836349Phonak Target 12.0Sonova AG12.02026-06-01
00858177007069hi Health InnovationsINTRICON CORPORATIONRemote2017-10-25
00858177007113Hearing Help ExpressINTRICON CORPORATIONHHE Hearing2019-02-25
00858177007144hiHealth InnovationsINTRICON CORPORATIONhiHearing2018-08-21
00858177007335Hearing Help ExpressINTRICON CORPORATIONHHE Hearing2020-09-01
00858177007458hearXINTRICON CORPORATIONLexie2020-07-28
00858177007465hearXINTRICON CORPORATIONLexie2020-07-28
00840094448117SoundWave™ Professional Suite SoftwareAdvanced Bionics, LLCCI-6055-0102023-01-13
00840094448131SoundWave™ Professional Suite SoftwareAdvanced Bionics, LLCCI-6055-0112023-01-13
00840094455276Target CIAdvanced Bionics, LLCCI-6057-0012023-01-13
00840094491014Target CIAdvanced Bionics, LLCCI-60572023-11-30
05708296434459GN HearingGn Hearing A/S239357002026-04-28
05708296434473GN HearingGn Hearing A/S239359002026-04-28
05708296434541GN HearingGn Hearing A/S239366002026-04-28
05708296434565GN HearingGn Hearing A/S239368002026-04-28
05708296435913GN HearingGn Hearing A/S240701002026-04-28
05708296435944GN HearingGn Hearing A/S240704002026-04-28
05708296435951GN HearingGn Hearing A/S240705002026-04-28
05708296435999GN HearingGn Hearing A/S240709002026-04-28
05708296436019GN HearingGn Hearing A/S240711002026-04-28
05708296436026GN HearingGn Hearing A/S240712002026-04-28
05708296436040GN HearingGn Hearing A/S240714002026-04-28
05708296436088GN HearingGn Hearing A/S240718002026-04-28
05708296436101GN HearingGn Hearing A/S240720002026-04-28
05708296436125GN HearingGn Hearing A/S240722002026-04-28
05714464167685BernafonSbo Hearing A/S2850302025-10-27
05714464167692BernafonSbo Hearing A/S2850312025-10-27
05714464167708PhilipsSbo Hearing A/S2850322025-10-27
05714464167715PhilipsSbo Hearing A/S2850332025-10-27
05714464167722OticonSbo Hearing A/S2850342025-10-27
05714464167746OticonSbo Hearing A/S2850362025-10-27
05714464167784AGXOSbo Hearing A/S2850402025-10-27
05714880283624ConnexxWs Audiology Usa, Inc.Connexx 9.142025-11-10
07613389847451DVD Phonak Target 11Sonova AG11.2 DVD2025-10-22
07613389847468USB Phonak Target 11Sonova AG11.2 USB2025-10-22
07613389847475Phonak Target 11Sonova AG11.22025-10-22
07613389860528myPhonak 7Sonova AG 7.32025-10-22
07613389860535Easy Line Remote 7Sonova AG7.32025-10-22
07613389860542myPhonak 7Sonova AG7.42025-10-22
07613389860559Easy Line Remote 7Sonova AG7.42025-10-22
07630016826382SoundWave™ Professional Suite Software 3.0Advanced Bionics AGCI-6055-0102016-09-23
07630016842177SoundWave™ Professional Suite SoftwareAdvanced Bionics AGCI-6055-0092015-10-30
07630016850578SoundWave™ Professional Suite SoftwareAdvanced Bionics AGCI-6055-0112017-05-24
07630016854262SoundWave™ Professional Suite SoftwareAdvanced Bionics AGCI-6055-0112017-07-21
07613389879841myPhonak 7Sonova AG7.52026-03-16
07613389879858Easy Line Remote 7Sonova AG7.52026-03-16
07613389879865myPhonak 7Sonova AG7.62026-03-16
07613389879872Easy Line Remote 7Sonova AG7.62026-03-16
05708296390243GN HearingGn Hearing A/S237709002026-03-05
05708296390328GN HearingGn Hearing A/S237717002026-03-05
05708296390410GN HearingGn Hearing A/S237726002026-03-05
05714464175406NeutralSbo Hearing A/S2860652026-01-07
05714464175413BernafonSbo Hearing A/S2860662026-01-07
05714464175420PhilipsSbo Hearing A/S2860672026-01-07
05714464175437PhilipsSbo Hearing A/S2860682026-01-07
05714464175444OticonSbo Hearing A/S2860692026-01-07
05714464175468OticonSbo Hearing A/S2860712026-01-07
05714464175505AGXOSbo Hearing A/S2860752026-01-07
07613389837810TrueFit 5.9 USBSonova AGn/a2025-12-30
07613389837827Unitron TrueFit 5.9Sonova AGn/a2025-12-30
07613389837841Aura:fit AudioNova 5.9Sonova AGn/a2025-12-30
07613389837858Aura:fit Relate 5.9Sonova AGn/a2025-12-30
05708296418404GN HearingGn Hearing A/S238475002025-12-01
05708296418459GN HearingGn Hearing A/S238480002025-12-01
05708296418473GN HearingGn Hearing A/S238482002025-12-01
05708296418480GN HearingGn Hearing A/S238483002025-12-01
05708296418503GN HearingGn Hearing A/S238485002025-12-01
05708296418541GN HearingGn Hearing A/S238489002025-12-01
05708296418565GN HearingGn Hearing A/S238491002025-12-01
05708296418589GN HearingGn Hearing A/S238493002025-12-01
05708296399796GN HearingGn Hearing A/S238376002025-09-19
05708296399826GN HearingGn Hearing A/S238379002025-09-21
05708296399833GN HearingGn Hearing A/S238380002025-09-21
05708296399871GN HearingGn Hearing A/S238384002025-09-21
05708296399895GN HearingGn Hearing A/S238386002025-09-21