Hearing Aid, Air-Conduction, Prescription
FDA product code ESD · 1367 cleared devices
Class 1
Ear, Nose, Throat
- Regulation
- 21 CFR 874.3300
- Review panel
- EN
- Implant
- No
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 1976-07-21 – 2024-04-11
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.
ESD
2024-04-11
ESD
2013-06-27
LYRIC2
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ESD
2008-05-08
LYRIC HEARING AID
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ESD
2002-11-19
INSOUND XT SERIES HEARING AID
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ESD
2001-04-24
TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)
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ESD
1999-03-12
SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH SOFT SHELL
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ESD
1998-03-06
TRANQUIL TRI-OE, TRANQUIL TRI-COE, TRANQUIL TRI-CIC
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ESD
1998-01-20
ARGOSY PROGRAMMABLE ONQUE
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ESD
1998-01-12
SONIX HEARING AID FITTING AND PROGRAMMING SYSTEM
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ESD
1997-12-15
OPUS 2 - FULL CONCHA SERIES - ITE
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ESD
1997-12-15
OPUS 2 - COMPLETELY-IN-CANAL SERIES (CIC)
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ESD
1997-12-15
OPUS 2 - CANAL SERIES (ITC)
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ESD
1997-12-12
UNITRON MODEL SOUND F/XP PROGRAMMABLE MINI BTE
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ESD
1997-12-12
UNITRON MODEL SOUND F/XD PROGRAMMABLE
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ESD
1997-12-12
UNITRON MODEL F/X PROGRAMMABLE (MINI BTE)
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ESD
1997-12-12
RESOUND DIGITAL 2000-BT W/DIGITAL 2000-DF (DIGITAL PROGRAMMER)
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ESD
1997-12-12
HI-69E, HI-69N, HI-69P
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ESD
1997-12-12
RESOUND STEALTH CIC
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ESD
1997-12-11
HYUNJAE CORPORATION - NUSIL EARMOLD IMPRESSION MATERIAL
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ESD
1997-11-19
FUTURA 67M, 68M, MEGAPOWERMP97, INTEGRA 70,71,72,73, SUPRA 51,52, SUPRA 56,57,58,59, SUPREMA 45, 46, 47,48
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ESD
1997-11-04
PERFECT EAR/ MINI-CANAL/ PE-M, PE-ML, PE-MD), PERFECT EAR/ C.I.C./ (PEC, PE-CD) (WITH OR WITHOUT RID-WAX BARRIER)
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ESD
1997-11-04
OTICON DIGISOUND COMPACT
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ESD
1997-11-04
OTICON DIGISOUND ITE
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ESD
1997-11-04
MAGNATONE / STERLING/ ST; MAGNATONE/DB; MAGNATONE/ LIBERTY/ LB; MAGNATONE/ PEARL/PH C.I.C., S.P.I., ONE TOUCH, DESIGNER
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ESD
1997-10-29
AIR CONDUCTION HEARING AID
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ESD
1997-10-28
DUALINE 100 BTE
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ESD
1997-10-28
AM SERIES HEARING AID
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ESD
1997-10-27
MODEL C-1 HEARING AID
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ESD
1997-10-17
D72 DIGITAL
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ESD
1997-10-14
LORI/LORI, LORI-S (LORI STOCK AID)
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ESD
1997-09-23
Z DEQ-II
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ESD
1997-09-08
DRY & STORE
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ESD
1997-09-05
PRISMA
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ESD
1997-08-25
NEW SOUND HIDDEN AID COMPLETELY IN CANAL (CIC)
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ESD
1997-08-15
PHONAK NOVO FORTE E3
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ESD
1997-08-15
LORIPRO, LORIPRO II
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ESD
1997-08-15
AIR CONDUCTION HAEARING AIDS
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ESD
1997-08-15
HEARTLAND TECHNOLOGIES, ITE, ITC, CIC
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ESD
1997-08-07
IN THE EAR, IN THE CANAL, COMPLETELY IN THE CANAL
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ESD
1997-08-05
V-12 LONG LIFE 675 HEARING AID
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ESD
1997-08-01
PHONAK EPICA
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ESD
1997-07-31
AUDIFON H24 AGC/AUDIFON H25 AGC/AUDIFON H30 AGC
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ESD
1997-07-30
AUDIFON H20 PC/AUDIFON H32 PP
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ESD
1997-07-30
PHONAK MICROZOOM P 2
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ESD
1997-07-29
OVATION HDP
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ESD
1997-07-23
TWIST PPAGC-1, TWIST PP
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ESD
1997-07-23
JAZZ PP AGC-O, JAZZ PP
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ESD
1997-07-23
MERIDIAN DSP
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ESD
1997-07-23
MIRACLE-EAR ITE DIGITAL
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ESD
1997-07-23
DAHLBERG/MIRACLE-EAR
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ESD
1997-07-23
MIRACLE-EAR DIGITAL BTE
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ESD
1997-07-23
BETTER HEARING, INC. MODEL L-1 HEARING AID
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ESD
1997-07-03
ARGOSY DYNAMEQ
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ESD
1997-07-03
RESOUND ED4 PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION
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ESD
1997-06-20
TONDI, MODELS U-03, U-2M1, U-2M4, KA-01, KA-02, KA-03, KA-03A, KA-04, KA-04A, KA-05
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ESD
1997-06-17
DANAVOX MODELS 163/162 BTE
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ESD
1997-06-17
AUDALLION III HEARING SYSTEM
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ESD
1997-06-13
AURIS AE, AURIS TL, AURIS HS, AURIS AC, AURIS MM, AURIS COE, AURIS CIC
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ESD
1997-06-13
DUALINE 400 CIC
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ESD
1997-06-06
PHILIPS S1694, S1695
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ESD
1997-06-06
RIONET HB-79P
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ESD
1997-06-06
WIDEX SENSO DIGITAL (MINI CANAL)
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ESD
1997-06-06
SCIENTIFIC PLASTICS MODEL SP
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ESD
1997-06-06
VISTA V-38 CIC
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ESD
1997-06-06
POWER D, TRU 5, PERSONA, PERSONA CHOICE, MERIDIAN
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ESD
1997-05-28
UHS MICRONET PROGRAMMABLE HEARING AIDS MODELS 901,902,903,906,909/PROGRAMMER
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ESD
1997-05-08
UNITRON MODEL SOUND F/X CIC
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ESD
1997-05-02
PRECISE IMPRESSION KIT
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ESD
1997-04-24
UNITRON MODEL SOUND F/X PROGRAMMABLE ITE (SF/X PROGRAMMABLE)
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ESD
1997-04-21
IN THE EAR HEARING AID
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ESD
1997-03-31
MULTI-CHANNEL COMPRESSION BTE (SD)
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ESD
1997-03-31
AUDALLION II HEARING SYSTEM
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ESD
1997-03-28
REXTON MODEL 48 AND 49PP
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ESD
1997-03-26
WIDEX SENSO DIGITAL (CIC)
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ESD
1997-03-12
WIDEX MODEL SENSO DIGITAL (C9)
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ESD
1997-03-11
ADAPTIVE COMPRESSION - CLASS D/ CLASS D AGCI
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ESD
1997-02-26
AHS OMEGA SP
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ESD
1997-02-11
SUPER K-AMP, EZ-COMPRESSION, TRIM-PRO, HF-PRO, ENVIRO-PRO, COMPRESSION-PRO, COMPRESSION 3000, HF 3000, OCTIVA, REFLEX HF
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ESD
1997-02-04
MIRACLE - EAR (ITE/ITC/CIC)
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ESD
1997-02-04
PRECISE, TYNMPANETTE, AND XACTO IMPRESSION KITS
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ESD
1997-01-27
AUDIOTONE (A-552)
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ESD
1997-01-27
AUDIOTONE (A554H)
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ESD
1997-01-27
DAHLBERG (A-554)
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ESD
1997-01-24
SENSO DIGITAL (C18)
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ESD
1997-01-24
M11 SERIES: M11, M11M
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ESD
1997-01-24
COMFORTAID HEARING AID
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ESD
1997-01-21
TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION-II
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ESD
1997-01-17
AUDINA 153 BEHIND THE EAR AND AUDINA 158 BEHIND THE EAR
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ESD
1996-12-26
MIRACLE-EAR OR AUDIOTONE
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ESD
1996-12-23
DAHLBERG K-AMP BTE
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ESD
1996-12-12
DIGIFOCUS ITE
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ESD
1996-12-06
ARTICULAR HEARING AIDS
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ESD
1996-12-06
AHS OMEGA HF
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ESD
1996-12-06
AHS OMEGA CONCEPT
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ESD
1996-12-05
IMPRESS, PERFECTA, ACU-FORM, AND ACUFIT
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ESD
1996-12-04
PHONAK MICROLINK, PERSONAL FM RECEIVER
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ESD
1996-11-27
RESOUND BT4 PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION
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ESD
1996-11-27
DAHLBERG HEARING AID WITH MULTI-CHANNEL COMPRESSION CIRCUIT
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ESD
1996-11-27
UNITRON MODEL SOUND F/XD +4 (SOUND F/XD +4)
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ESD
1996-11-27
UNITRON MODEL ICON AOHPD +4 (ICON AOHPD +4)
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