FDA.reportPublic FDA data

Air-conduction hearing aid, in-the-ear

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
2,591
Last updated
2026-10-06 03:50:01

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
05714880291278TRUHEARINGWs Audiology Usa, Inc.TH Premium 7 CIC LI2026-01-20
05714880291285TRUHEARINGWs Audiology Usa, Inc.TH Advanced 7 CIC LI2026-01-20
05714880291292TRUHEARINGWs Audiology Usa, Inc.TH Standard 7 CIC LI2026-01-20
06943786093726AUDIENAustar Hearing Science & Technology (Xiamen) Co., Ltd men) Co., Ltd.ATOM ONE2026-09-20
06943786094792AUDIENAustar Hearing Science & Technology (Xiamen) Co., Ltd men) Co., Ltd.ATOM Air2026-09-20
06945936700218NeosonicXiamen New Sound Technology Co., Ltd.Neosonic Qt2020-12-31
06945936700263EarplugXiamen New Sound Technology Co., Ltd.New TI 1002020-12-31
06945936700331EarCentricXiamen New Sound Technology Co., Ltd.ER81N2020-12-31
06945936700454SOUNDWEARXiamen New Sound Technology Co., Ltd.SOUNDWEAR ULITE2000 L White2020-12-31
06945936700461SOUNDWEARXiamen New Sound Technology Co., Ltd.SOUNDWEAR ULITE2000 R White2020-12-31
06945936700591EarupXiamen New Sound Technology Co., Ltd.POCO X4012020-12-31
06945936700690EarupXiamen New Sound Technology Co., Ltd.POCO R101 L2020-12-31
06945936700713EarupXiamen New Sound Technology Co., Ltd.POCO R101 R2020-12-31
06945936701758LUXATOXiamen New Sound Technology Co., Ltd.LUX 102020-12-31
06945936701765LUXATOXiamen New Sound Technology Co., Ltd.LUX 12 L2020-12-31
06945936701772LUXATOXiamen New Sound Technology Co., Ltd.LUX 12 R2020-12-31
06945936701857MicrotechXiamen New Sound Technology Co., Ltd.IRIS10S2020-12-31
06945936703288NewsoundXiamen New Sound Technology Co., Ltd.POCO ZA4012022-09-05
06945936703349NewSoundXiamen New Sound Technology Co., Ltd.Poco XA6012022-09-08
06945936703363WENKEYXiamen New Sound Technology Co., Ltd.WE-6012022-09-08
06945936703448NeosonicXiamen New Sound Technology Co., Ltd.Neosonic BT-Omni2022-09-09
06945936703721NewsoundXiamen New Sound Technology Co., Ltd.TactEar 8012023-11-17
06945936704063NanoXiamen New Sound Technology Co., Ltd.First Ear Plus ITE2024-05-21
06945936799106NewsoundXiamen New Sound Technology Co., Ltd.HearIQ ITC2021-07-31
06974608620523PHONELUMShenzhen Eartech Co., Ltd.Sara 102026-08-27
00850080488577flysoundShenzhen Flysounds Medical Technology Co.,Ltd.B012026-08-25
00850080488584flysoundShenzhen Flysounds Medical Technology Co.,Ltd.B01 Pro2026-08-25
06971094538844N/AHuizhou Jinghao Medical Technology Co., LtdJH-A2602026-08-23
00850065321967CeretoneAudicon CorporationSynvix2026-08-14
06943786094846AUSTARAustar Hearing Science & Technology (Xiamen) Co., Ltd men) Co., Ltd.ATOM X Connect2026-08-14
00850010429540Eargo 8Eargo, Inc.99-0181-0012025-05-13
00850010429779Eargo SEEargo, Inc.99-0198-0012025-10-22
00850010429786Eargo 8Eargo, Inc.99-0179-001-U2026-04-20
00850010429793Eargo 8Eargo, Inc.99-0193-0012025-05-13
00850010429847Eargo SEEargo, Inc.99-0201-0012026-04-20
06971094538806Modern HearingHuizhou Jinghao Medical Technology Co., LtdJH-A26A2026-08-01
05714880182743SonyWs Audiology Usa, Inc.CRE-C102022-09-12
05714880182781SonyWs Audiology Usa, Inc.CRE-E102023-05-30
05714880215144SonyWs Audiology Usa, Inc.CRE-C202024-07-01
05714880215151SonyWs Audiology Usa, Inc.CRE-C202024-07-01
05714880227154SonyWs Audiology Usa, Inc.CRE-C202024-07-18
05714878800291MIRACLE EARWs Audiology Usa, Inc.MEMINI I 4 5W CIC-R2026-07-29
05714878800307MIRACLE EARWs Audiology Usa, Inc.MEMINI I 5 5W CIC-R2026-07-29
05714878800314MIRACLE EARWs Audiology Usa, Inc.MEMINI I 3 5W CIC-R2026-07-29
05714878800352MIRACLE EARWs Audiology Usa, Inc.MEMINI I 2 5W CIC-R2026-07-29
06980305290013CEARVOLSHENZHEN CANNICE TECHNOLOGY CO.,LTDWave Lite2026-07-25
06980305290020CEARVOLSHENZHEN CANNICE TECHNOLOGY CO.,LTDNano2026-07-25
06980305290037CEARVOLSHENZHEN CANNICE TECHNOLOGY CO.,LTDNano 22026-07-25
06980305290044CEARVOLSHENZHEN CANNICE TECHNOLOGY CO.,LTDLiberte2026-07-25
06980305290068CEARVOLSHENZHEN CANNICE TECHNOLOGY CO.,LTDDiamond X12026-07-25
06980305290082CEARVOLSHENZHEN CANNICE TECHNOLOGY CO.,LTDNano2026-07-25
06980305290099CEARVOLSHENZHEN CANNICE TECHNOLOGY CO.,LTDWave Lite2026-07-25
06980305290105CEARVOLSHENZHEN CANNICE TECHNOLOGY CO.,LTDNano 22026-07-25
06980305290112CEARVOLSHENZHEN CANNICE TECHNOLOGY CO.,LTDLiberte2026-07-25
06980305290129CEARVOLSHENZHEN CANNICE TECHNOLOGY CO.,LTDDiamond X12026-07-25
05714880296440SIGNIAWs Audiology Usa, Inc.KIT Silk C&G 7IX RB2026-07-22
05714880296464SIGNIAWs Audiology Usa, Inc.KIT Silk C&G 7IX RB2026-07-22
05714880296488SIGNIAWs Audiology Usa, Inc.KIT Silk C&G 5IX RB2026-07-22
05714880296501SIGNIAWs Audiology Usa, Inc.KIT Silk C&G 5IX RB2026-07-22
05714880296525SIGNIAWs Audiology Usa, Inc.KIT Silk C&G 3IX RB2026-07-22
05714880296549SIGNIAWs Audiology Usa, Inc.KIT Silk C&G 3IX RB2026-07-22
05714880296563SIGNIAWs Audiology Usa, Inc.KIT Silk C&G 2IX RB2026-07-22
05714880296587SIGNIAWs Audiology Usa, Inc.KIT Silk C&G 2IX RB2026-07-22
05714880296600SIGNIAWs Audiology Usa, Inc.KIT Silk C&G 1IX RB2026-07-22
05714880296624SIGNIAWs Audiology Usa, Inc.KIT Silk C&G 1IX RB2026-07-22
05714880296648SIGNIAWs Audiology Usa, Inc.KIT Silk C&G sDemo DIX RB2026-07-22
00850065321714CeretoneAudicon CorporationLuma2026-06-25
06971094538783Smart HearingHuizhou Jinghao Medical Technology Co., LtdJH-A26A2026-06-22
06971094538790SOUNDFITHuizhou Jinghao Medical Technology Co., LtdJH-A26A2026-07-03
06945936705701QuietlyBoldXiamen New Sound Technology Co., Ltd.Flow2026-06-09
06977171530022TECHMITechmi (HongKong) Co., LimitedMatch-Pearl White2026-06-03
06977171530039TECHMITechmi (HongKong) Co., LimitedMatch-Black2026-06-03
05714880219425Audio ServiceWs Audiology Usa, Inc.IF CIC Li 8.162026-05-28
05714880219432Audio ServiceWs Audiology Usa, Inc.IF CIC Li 8.162026-05-28
05714880219449Audio ServiceWs Audiology Usa, Inc.IF CIC Li 8.162026-05-28
05714880219456Audio ServiceWs Audiology Usa, Inc.IF CIC Li 8.162026-05-28
05714880219463Audio ServiceWs Audiology Usa, Inc.IF CIC Li 8.162026-05-28
05714880219470Audio ServiceWs Audiology Usa, Inc.IF CIC Li 8.162026-05-28
05714880219869Audio ServiceWs Audiology Usa, Inc.IF CIC Li 8.82026-05-28
05714880219876Audio ServiceWs Audiology Usa, Inc.IF CIC Li 8.82026-05-28