FDA.reportPublic FDA data

In-the-ear air-conduction hearing aid

Definition
A battery-powered acoustic device intended to compensate for impaired hearing by transmitting amplified sound waves to the eardrum through air. It typically consists of a miniature microphone, amplifier, and speaker (receiver) contained in a case that fits completely inside the outer ear (concha) [in-the-ear (ITE)]. The microphone receives sound waves and converts them into electrical signals which are increased by the amplifier and sent as sound waves, by the speaker, to the eardrum. The device is used for mild to severe hearing loss; most types are programmable to enable computerized adjustments for a patient's hearing loss and related factors.
GUDID devices
4,431
Last updated
2020-08-17 07:15:50

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
05708296199501GN HearingGn Hearing A/SADV562-ITE-DW-HP2020-08-07
05708296199518GN HearingGn Hearing A/SADV562-ITE-DW-MP2020-08-07
05708296199525GN HearingGn Hearing A/SADV562-ITE-DW-UP2020-08-07
05708296199617GN HearingGn Hearing A/SADV662-ITE-DW-HP2020-08-07
05708296199624GN HearingGn Hearing A/SADV662-ITE-DW-MP2020-08-07
05708296199631GN HearingGn Hearing A/SADV662-ITE-DW-UP2020-08-07
05708296199723GN HearingGn Hearing A/SADV862-ITE-DW-HP2020-08-07
05708296199730GN HearingGn Hearing A/SADV862-ITE-DW-MP2020-08-07
05708296199747GN HearingGn Hearing A/SADV862-ITE-DW-UP2020-08-07
07613389362459Phonak BrandSonova AG063-0506-012020-07-22
07613389393095Phonak BrandSonova AG050-0769-00902020-07-22
00888151014097Walker's®HEARING LAB TECHNOLOGY, LLCIIC2018-09-21
00888151014103Walker's®HEARING LAB TECHNOLOGY, LLCITCD2018-09-21
10818323023012ViveVIVE HEALTH LLCLVA1087IS2019-03-20
10818323023029ViveVIVE HEALTH LLCLVA1087IP2019-03-20
00812944027230Lucid®HEARING LAB TECHNOLOGY, LLCFS2019-11-25
00812944027247Lucid®HEARING LAB TECHNOLOGY, LLCHS2019-11-25
00812944027254Lucid®HEARING LAB TECHNOLOGY, LLCCA2019-11-25
00812944027261Lucid®HEARING LAB TECHNOLOGY, LLCMC2019-11-25
00812944027278Lucid®HEARING LAB TECHNOLOGY, LLCCIC2019-11-25
07613389332896UnitronUnitron Hearing Division063-6197-012020-03-28
07613389332926UnitronUnitron Hearing Division063-6200-012020-03-28
07613389341157UnitronUnitron Hearing Division063-6203-012020-03-28
00842318180049AUDIOSYNCStarkey Laboratories, Inc.AUDIOSYNC VIA EDGE AI 2400 ITE R2020-03-11
00842318180056AUDIGYStarkey Laboratories, Inc.AUDIGY AGXSLIV EDGE AI 2400 ITE R2020-03-11
00842318180070MICROTECHStarkey Laboratories, Inc.MICROTECH ESENTIA EDGE AI 2400 ITE R2020-03-11
00842318180100AUDIBELStarkey Laboratories, Inc.AUDIBEL VIA AI 2400 ITE R2020-03-11
00842318180117AUDIOSYNCStarkey Laboratories, Inc.AUDIOSYNC VIA AI 2400 ITE R2020-03-11
00842318180124AUDIGYStarkey Laboratories, Inc.AUDIGY AGXSLIV AI 2400 ITE R2020-03-11
00842318180131MICROTECHStarkey Laboratories, Inc.MICROTECH ESENTIA AI 2400 ITE R2020-03-11
00842318180155STARKEYStarkey Laboratories, Inc.STARKEY LIVIO AI 2400 ITE R2020-03-11
00842318180162AUDIBELStarkey Laboratories, Inc.AUDIBEL VIA AI 2000 ITE R2020-03-11
00842318180209MICROTECHStarkey Laboratories, Inc.MICROTECH ESENTIA AI 2000 ITE R2020-03-11
00842318180216NUEARStarkey Laboratories, Inc.NUEAR CIRCA AI 2000 ITE R2020-03-11
00842318180230AUDIBELStarkey Laboratories, Inc.AUDIBEL VIA AI 1600 ITE R2020-03-11
00842318180292STARKEYStarkey Laboratories, Inc.STARKEY LIVIO AI 1600 ITE R2020-03-11
00842318180315AUDIOSYNCStarkey Laboratories, Inc.AUDIOSYNC VIA AI 1200 ITE R2020-03-11
00842318180322AUDIGYStarkey Laboratories, Inc.AUDIGY AGXSLIV AI 1200 ITE R2020-03-11
00842318180377AUDIBELStarkey Laboratories, Inc.AUDIBEL VIA AI 1000 ITE R2020-03-11
00842318180384AUDIOSYNCStarkey Laboratories, Inc.AUDIOSYNC VIA AI 1000 ITE R2020-03-11
00842318180391AUDIGYStarkey Laboratories, Inc.AUDIGY AGXSLIV AI 1000 ITE R2020-03-11
00842318180414MICROTECHStarkey Laboratories, Inc.MICROTECH ESENTIA AI 1000 ITE R2020-03-11
00842318180421NUEARStarkey Laboratories, Inc.NUEAR CIRCA AI 1000 ITE R2020-03-11
00842318180445AUDIBELStarkey Laboratories, Inc.AUDIBEL VIA 2400 ITE R2020-03-11
00842318180483MICROTECHStarkey Laboratories, Inc.MICROTECH ESENTIA 2400 ITE R2020-03-11
00842318180490NUEARStarkey Laboratories, Inc.NUEAR CIRCA 2400 ITE R2020-03-11
00842318180513AUDIBELStarkey Laboratories, Inc.AUDIBEL VIA 2000 ITE R2020-03-11
00842318180537AUDIGYStarkey Laboratories, Inc.AUDIGY AGXSLIV 2000 ITE R2020-03-11
00842318180568NUEARStarkey Laboratories, Inc.NUEAR CIRCA 2000 ITE R2020-03-11
00842318180575STARKEYStarkey Laboratories, Inc.STARKEY LIVIO 2000 ITE R2020-03-11
00842318180599AUDIOSYNCStarkey Laboratories, Inc.AUDIOSYNC VIA 1600 ITE R2020-03-11
00842318180629MICROTECHStarkey Laboratories, Inc.MICROTECH ESENTIA 1600 ITE R2020-03-11
00842318180711STARKEYStarkey Laboratories, Inc.STARKEY LIVIO 1200 ITE R2020-03-11
00842318180728AUDIBELStarkey Laboratories, Inc.AUDIBEL VIA 1000 ITE R2020-03-11
07613389276503PhonakSonova AG063-0488-012020-02-16
07613389276510PhonakSonova AG063-0489-012020-02-16
07613389276527PhonakSonova AG063-0490-012020-02-16
07613389276534PhonakSonova AG063-0491-012020-02-16
07613389276541PhonakSonova AG063-0492-012020-02-16
07613389276558PhonakSonova AG063-0493-012020-02-16
07613389276565PhonakSonova AG063-0494-012020-02-16
07613389276572PhonakSonova AG063-0495-012020-02-16
07613389276589PhonakSonova AG063-0496-012020-02-16
07613389276596PhonakSonova AG063-0497-012020-02-16
07613389276602PhonakSonova AG063-0498-012020-02-16
07613389276619PhonakSonova AG063-0499-012020-02-16
07613389276626PhonakSonova AG063-0500-012020-02-16
07613389276633PhonakSonova AG063-0501-012020-02-16
00812944023980America Hears®HEARING LAB TECHNOLOGY, LLC62492020-02-07
00812944026899CapsureHEARING LAB TECHNOLOGY, LLC92492020-02-07
00812944026905CapsureHEARING LAB TECHNOLOGY, LLC92492020-02-07
00812944027186Liberty®HEARING LAB TECHNOLOGY, LLC92492020-02-07
05706069886719WidexWidex A/SM-XP2020-02-01
05706069886726WidexWidex A/SM-XP2020-02-01
05706069886733WidexWidex A/SM-XP2020-02-01
05706069886832WidexWidex A/SM-XP2020-02-01
05706069886849WidexWidex A/SM-XP2020-02-01
05706069886856WidexWidex A/SM-XP2020-02-01
05706069886863WidexWidex A/SM-XP2020-02-01
05706069886870WidexWidex A/SM-XP2020-02-01