Atlas FDA

ESD

1,367 FDA 510(k) clearances · Product code

42 daysmedian time to decision
104 days90th percentile
1,367clearances measured

FDA profile

Official device name
Hearing Aid, Air-Conduction, Prescription
Device class
Class I (low risk)
Regulation
21 CFR 874.3300
Medical specialty
Ear, Nose, Throat
FDA definition
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.
Adverse events (MAUDE)
2012: 6 · 2013: 37 · 2018: 12 · 2024: 16 · 2025: 53 · 2026: 22
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Lyric4 Hearing Aid (K232999)Sonova AG2024-04-11
LYRIC2 (K130790)Phonak, LLC2013-06-27
LYRIC HEARING AID (K081136)Insound Medical, Inc.2008-05-08
INSOUND XT SERIES HEARING AID (K021867)Insound Medical, Inc.2002-11-19
TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION) (K003558)Siemens Hearing Instruments, Inc.2001-04-24
SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH SOFT SHELL (K984518)Sonic Innovations, Inc.1999-03-12
TRANQUIL TRI-OE, TRANQUIL TRI-COE, TRANQUIL TRI-CIC (K974751)General Hearing Instruments, Inc.1998-03-06
ARGOSY PROGRAMMABLE ONQUE (K974242)Argosy Electronics1998-01-20
SONIX HEARING AID FITTING AND PROGRAMMING SYSTEM (K973880)Sonix Technologies, Inc.1998-01-12
OPUS 2 - CANAL SERIES (ITC) (K974069)Bernafon-Maico, Inc.1997-12-15
OPUS 2 - COMPLETELY-IN-CANAL SERIES (CIC) (K974152)Bernafon-Maico, Inc.1997-12-15
OPUS 2 - FULL CONCHA SERIES - ITE (K974211)Bernafon-Maico, Inc.1997-12-15
RESOUND STEALTH CIC (K974081)Resound Corp.1997-12-12
UNITRON MODEL SOUND F/XP PROGRAMMABLE MINI BTE (K974340)Unitron Industries, Inc.1997-12-12
UNITRON MODEL SOUND F/XD PROGRAMMABLE (K974339)Unitron Industries, Inc.1997-12-12
UNITRON MODEL F/X PROGRAMMABLE (MINI BTE) (K974338)Unitron Industries, Inc.1997-12-12
HI-69E, HI-69N, HI-69P (K974129)Rockwin Corp.1997-12-12
RESOUND DIGITAL 2000-BT W/DIGITAL 2000-DF (DIGITAL PROGRAMMER) (K974257)Resound Corp.1997-12-12
HYUNJAE CORPORATION - NUSIL EARMOLD IMPRESSION MATERIAL (K973927)Hyunjae Corp.1997-12-11
FUTURA 67M, 68M, MEGAPOWERMP97, INTEGRA 70,71,72,73, SUPRA 51,52, SUPRA 56,57,58,59, SUPREMA 45, 46, 47,48 (K973861)Magnatone Hearing Aid Corp.1997-11-19
PERFECT EAR/ MINI-CANAL/ PE-M, PE-ML, PE-MD), PERFECT EAR/ C.I.C./ (PEC, PE-CD) (WITH OR WITHOUT RID-WAX BARRIER) (K973972)Perfect Ear1997-11-04
MAGNATONE / STERLING/ ST; MAGNATONE/DB; MAGNATONE/ LIBERTY/ LB; MAGNATONE/ PEARL/PH C.I.C., S.P.I., ONE TOUCH, DESIGNER (K973665)Magnatone Hearing Aid Corp.1997-11-04
OTICON DIGISOUND COMPACT (K973886)Oticon, Inc.1997-11-04
OTICON DIGISOUND ITE (K973885)Oticon, Inc.1997-11-04
AIR CONDUCTION HEARING AID (K973846)Baron Trading, Inc.1997-10-29
DUALINE 100 BTE (K973948)Bernafon-Maico, Inc.1997-10-28
AM SERIES HEARING AID (K973579)A & M Hearing, Ltd.1997-10-28
MODEL C-1 HEARING AID (K973043)Better Hearing, Inc.1997-10-27
D72 DIGITAL (K972818)Philips Hearing Instruments Co.1997-10-17
LORI/LORI, LORI-S (LORI STOCK AID) (K973376)Lori Medical Laboratories, Inc.1997-10-14
Z DEQ-II (K973266)Electone, Inc.1997-09-23
DRY & STORE (K972776)Ear Technology Corp.1997-09-08
PRISMA (K972998)Siemens Hearing Instruments, Inc.1997-09-05
NEW SOUND HIDDEN AID COMPLETELY IN CANAL (CIC) (K972039)Nu-Sound1997-08-25
HEARTLAND TECHNOLOGIES, ITE, ITC, CIC (K971845)Sound Hearing Instruments, Inc.1997-08-15
AIR CONDUCTION HAEARING AIDS (K971852)Beltone Electronics Corp.1997-08-15
LORIPRO, LORIPRO II (K972058)Lori Medical Laboratories, Inc.1997-08-15
PHONAK NOVO FORTE E3 (K972106)Phonak, Inc.1997-08-15
IN THE EAR, IN THE CANAL, COMPLETELY IN THE CANAL (K971807)Hear-Right, Inc.1997-08-07
V-12 LONG LIFE 675 HEARING AID (K972755)Vista Labs1997-08-05
PHONAK EPICA (K972105)Phonak, Inc.1997-08-01
AUDIFON H24 AGC/AUDIFON H25 AGC/AUDIFON H30 AGC (K972550)Trutone1997-07-31
PHONAK MICROZOOM P 2 (K972097)Phonak, Inc.1997-07-30
AUDIFON H20 PC/AUDIFON H32 PP (K972552)Trutone1997-07-30
OVATION HDP (K972373)Orsonique, Inc.1997-07-29
MIRACLE-EAR DIGITAL BTE (K972344)Miracle-Ear, Inc.1997-07-23
BETTER HEARING, INC. MODEL L-1 HEARING AID (K971298)Better Hearing, Inc.1997-07-23
MIRACLE-EAR ITE DIGITAL (K972346)Miracle-Ear, Inc.1997-07-23
JAZZ PP AGC-O, JAZZ PP (K972542)Trutone1997-07-23
TWIST PPAGC-1, TWIST PP (K972543)Trutone1997-07-23
DAHLBERG/MIRACLE-EAR (K972345)Miracle-Ear, Inc.1997-07-23
MERIDIAN DSP (K972431)Micro-Ear Technology, Inc.1997-07-23
ARGOSY DYNAMEQ (K971699)Argosy Electronics1997-07-03
RESOUND ED4 PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION (K971605)Resound Corp.1997-07-03
TONDI, MODELS U-03, U-2M1, U-2M4, KA-01, KA-02, KA-03, KA-03A, KA-04, KA-04A, KA-05 (K971296)National Hearing Aid Dist., Inc.1997-06-20
DANAVOX MODELS 163/162 BTE (K971032)Gn Danavox, Inc.1997-06-17
AUDALLION III HEARING SYSTEM (K971031)Gn Danavox, Inc.1997-06-17
DUALINE 400 CIC (K971158)Bernafon-Maico, Inc.1997-06-13
AURIS AE, AURIS TL, AURIS HS, AURIS AC, AURIS MM, AURIS COE, AURIS CIC (K971399)General Hearing Instruments, Inc.1997-06-13
PHILIPS S1694, S1695 (K971804)Philips Hearing Instruments Co.1997-06-06
WIDEX SENSO DIGITAL (MINI CANAL) (K971535)Widex Hearing Aid Co., Inc.1997-06-06
RIONET HB-79P (K971693)Authorized Hearing Systems, Inc.1997-06-06
VISTA V-38 CIC (K970939)Vista Labs1997-06-06
POWER D, TRU 5, PERSONA, PERSONA CHOICE, MERIDIAN (K970880)Micro-Ear Technology, Inc.1997-06-06
SCIENTIFIC PLASTICS MODEL SP (K971299)Scientific Plastics, Inc.1997-06-06
UHS MICRONET PROGRAMMABLE HEARING AIDS MODELS 901,902,903,906,909/PROGRAMMER (K970828)United Hearing Systems, Inc.1997-05-28
UNITRON MODEL SOUND F/X CIC (K970692)Unitron Industries, Inc.1997-05-08
PRECISE IMPRESSION KIT (K970952)Starkey Laboratories, Inc.1997-05-02
UNITRON MODEL SOUND F/X PROGRAMMABLE ITE (SF/X PROGRAMMABLE) (K970519)Unitron Industries, Inc.1997-04-24
IN THE EAR HEARING AID (K964898)Keytone Hearing Laboratory1997-04-21
MULTI-CHANNEL COMPRESSION BTE (SD) (K970262)Miracle-Ear, Inc.1997-03-31
AUDALLION II HEARING SYSTEM (K970215)Resound Corp.1997-03-31
REXTON MODEL 48 AND 49PP (K970537)Rexton, Inc.1997-03-28
WIDEX SENSO DIGITAL (CIC) (K970904)Widex Hearing Aid Co., Inc.1997-03-26
WIDEX MODEL SENSO DIGITAL (C9) (K965254)Widex Hearing Aid Co., Inc.1997-03-12
ADAPTIVE COMPRESSION - CLASS D/ CLASS D AGCI (K970430)Midwest City Hearing Aid Center1997-03-11
AHS OMEGA SP (K970057)Authorized Hearing Systems, Inc.1997-02-26
SUPER K-AMP, EZ-COMPRESSION, TRIM-PRO, HF-PRO, ENVIRO-PRO, COMPRESSION-PRO, COMPRESSION 3000, HF 3000, OCTIVA, REFLEX HF (K964657)Micro-Ear Technology, Inc.1997-02-11
MIRACLE - EAR (ITE/ITC/CIC) (K964419)Miracle-Ear, Inc.1997-02-04
PRECISE, TYNMPANETTE, AND XACTO IMPRESSION KITS (K964245)Starkey Laboratories, Inc.1997-02-04
AUDIOTONE (A-552) (K965063)Miracle-Ear, Inc.1997-01-27
AUDIOTONE (A554H) (K965057)Miracle-Ear, Inc.1997-01-27
DAHLBERG (A-554) (K965049)Miracle-Ear, Inc.1997-01-27
M11 SERIES: M11, M11M (K965088)Philips Hearing Instruments Co.1997-01-24
COMFORTAID HEARING AID (K964680)Ethical Hearing Instruments1997-01-24
SENSO DIGITAL (C18) (K965218)Widex Hearing Aid Co., Inc.1997-01-24
TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION-II (K964639)Telex Communications, Inc.1997-01-21
AUDINA 153 BEHIND THE EAR AND AUDINA 158 BEHIND THE EAR (K964816)Audina Hearing Instrument1997-01-17
MIRACLE-EAR OR AUDIOTONE (K964669)Miracle-Ear, Inc.1996-12-26
DAHLBERG K-AMP BTE (K964794)Miracle-Ear, Inc.1996-12-23
DIGIFOCUS ITE (K964683)Oticon, Inc.1996-12-12
AHS OMEGA HF (K963878)Authorized Hearing Systems, Inc.1996-12-06
AHS OMEGA CONCEPT (K963877)Authorized Hearing Systems, Inc.1996-12-06
ARTICULAR HEARING AIDS (K964603)Decibel Instruments, Inc.1996-12-06
IMPRESS, PERFECTA, ACU-FORM, AND ACUFIT (K963958)Beltone Electronics Corp.1996-12-05
PHONAK MICROLINK, PERSONAL FM RECEIVER (K964035)Phonak, Inc.1996-12-04
UNITRON MODEL ICON AOHP +4 (ICON AOHP +4) (K964508)Unitron Industries, Inc.1996-11-27
RESOUND BT4 PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION (K964557)Resound Corp.1996-11-27
AHS OMEGA K-AMP (K963875)Authorized Hearing Systems, Inc.1996-11-27
DAHLBERG HEARING AID WITH MULTI-CHANNEL COMPRESSION CIRCUIT (K964530)Miracle-Ear, Inc.1996-11-27
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