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510(k) Predicate Database
Product code ESDClass 1

Hearing Aid, Air-Conduction, Prescription 510(k) Clearances

Product code ESD is the FDA classification for Hearing Aid, Air-Conduction, Prescription, a Class 1 device regulated under 21 CFR 874.3300, reviewed by the FDA Ear, Nose, Throat panel. FDA has cleared 1,367 510(k) submissions under this product code.

An air-conduction hearing aid is a wearable sound amplifying device intended to compensate for impaired hearing that conducts sound to the ear through the air. This is a prescription hearing aid.

Devices under product code ESDshare an FDA classification category, but product-code overlap does not establish the same intended use, technological characteristics, or legal predicate eligibility. Treat this list as a screening cohort and review each device's indications, labeling, substantial-equivalence summary, and current legal-marketing status.

Cleared devices
1,367
Device class
Class 1
Regulation
874.3300
Latest clearance

Cleared devices under product code ESD

Showing the 50 most recent of 1,367 cleared devices. Clearances from 1997-07-23 to 2024-04-11.

FDA-cleared devices under product code ESD
510(k)DeviceApplicantDecision date
K232999Lyric4 Hearing AidSonova AG
K130790LYRIC2Phonak, LLC
K081136LYRIC HEARING AIDInsound Medical, Inc.
K021867INSOUND XT SERIES HEARING AIDInsound Medical, Inc.
K003558TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)Siemens Hearing Instruments, Inc.
K984518SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH SOFT SHELLSonic Innovations, Inc.
K974751TRANQUIL TRI-OE, TRANQUIL TRI-COE, TRANQUIL TRI-CICGeneral Hearing Instruments, Inc.
K974242ARGOSY PROGRAMMABLE ONQUEArgosy Electronics
K973880SONIX HEARING AID FITTING AND PROGRAMMING SYSTEMSonix Technologies, Inc.
K974069OPUS 2 - CANAL SERIES (ITC)Bernafon-Maico, Inc.
K974152OPUS 2 - COMPLETELY-IN-CANAL SERIES (CIC)Bernafon-Maico, Inc.
K974211OPUS 2 - FULL CONCHA SERIES - ITEBernafon-Maico, Inc.
K974081RESOUND STEALTH CICResound Corp.
K974129HI-69E, HI-69N, HI-69PRockwin Corp.
K974257RESOUND DIGITAL 2000-BT W/DIGITAL 2000-DF (DIGITAL PROGRAMMER)Resound Corp.
K974338UNITRON MODEL F/X PROGRAMMABLE (MINI BTE)Unitron Industries, Inc.
K974339UNITRON MODEL SOUND F/XD PROGRAMMABLEUnitron Industries, Inc.
K974340UNITRON MODEL SOUND F/XP PROGRAMMABLE MINI BTEUnitron Industries, Inc.
K973927HYUNJAE CORPORATION - NUSIL EARMOLD IMPRESSION MATERIALHyunjae Corp.
K973861FUTURA 67M, 68M, MEGAPOWERMP97, INTEGRA 70,71,72,73, SUPRA 51,52, SUPRA 56,57,58,59, SUPREMA 45, 46, 47,48Magnatone Hearing Aid Corp.
K973665MAGNATONE / STERLING/ ST; MAGNATONE/DB; MAGNATONE/ LIBERTY/ LB; MAGNATONE/ PEARL/PH C.I.C., S.P.I., ONE TOUCH, DESIGNERMagnatone Hearing Aid Corp.
K973885OTICON DIGISOUND ITEOticon, Inc.
K973886OTICON DIGISOUND COMPACTOticon, Inc.
K973972PERFECT EAR/ MINI-CANAL/ PE-M, PE-ML, PE-MD), PERFECT EAR/ C.I.C./ (PEC, PE-CD) (WITH OR WITHOUT RID-WAX BARRIER)Perfect Ear
K973846AIR CONDUCTION HEARING AIDBaron Trading, Inc.
K973579AM SERIES HEARING AIDA & M Hearing, Ltd.
K973948DUALINE 100 BTEBernafon-Maico, Inc.
K973043MODEL C-1 HEARING AIDBetter Hearing, Inc.
K972818D72 DIGITALPhilips Hearing Instruments Co.
K973376LORI/LORI, LORI-S (LORI STOCK AID)Lori Medical Laboratories, Inc.
K973266Z DEQ-IIElectone, Inc.
K972776DRY & STOREEar Technology Corp.
K972998PRISMASiemens Hearing Instruments, Inc.
K972039NEW SOUND HIDDEN AID COMPLETELY IN CANAL (CIC)Nu-Sound
K971845HEARTLAND TECHNOLOGIES, ITE, ITC, CICSound Hearing Instruments, Inc.
K971852AIR CONDUCTION HAEARING AIDSBeltone Electronics Corp.
K972058LORIPRO, LORIPRO IILori Medical Laboratories, Inc.
K972106PHONAK NOVO FORTE E3Phonak, Inc.
K971807IN THE EAR, IN THE CANAL, COMPLETELY IN THE CANALHear-Right, Inc.
K972755V-12 LONG LIFE 675 HEARING AIDVista Labs
K972105PHONAK EPICAPhonak, Inc.
K972550AUDIFON H24 AGC/AUDIFON H25 AGC/AUDIFON H30 AGCTrutone
K972097PHONAK MICROZOOM P 2Phonak, Inc.
K972552AUDIFON H20 PC/AUDIFON H32 PPTrutone
K972373OVATION HDPOrsonique, Inc.
K971298BETTER HEARING, INC. MODEL L-1 HEARING AIDBetter Hearing, Inc.
K972344MIRACLE-EAR DIGITAL BTEMiracle-Ear, Inc.
K972345DAHLBERG/MIRACLE-EARMiracle-Ear, Inc.
K972346MIRACLE-EAR ITE DIGITALMiracle-Ear, Inc.
K972431MERIDIAN DSPMicro-Ear Technology, Inc.

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