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
1994-11-14
ESD
1994-10-21
PROGRAM 3-CH SER HEAR AIDS W/PROGRAM FIT SYST/PRO FIT
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ESD
1994-10-20
WIDEX MODEL LX-ITE
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ESD
1994-10-20
BELTONE CONCERTO S
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ESD
1994-10-20
UV CURED METHYL METHACRYLATE HEARING AID SHELL MATERIALS
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ESD
1994-10-20
FEDELITY F495, VIENNATONE ALPP II
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ESD
1994-10-12
PROGRAM 3-CH SERIES HEAR AIDS W/DT-1 DESKTOP PROGRAM
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ESD
1994-09-23
MIRACLE-EAR MIRAGE
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ESD
1994-09-23
MIRACLE-EAR IMPRESSION MATERIAL KIT
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ESD
1994-09-21
MIRACLE EAR CONFIDANTE
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ESD
1994-09-21
RESOUND PERSONAL HEARING SYSTEM
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ESD
1994-09-16
ALL-IN-THE-EAR
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ESD
1994-09-07
INFINITY 252
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ESD
1994-09-07
SIEMENS MODEL 584 P-2
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ESD
1994-08-22
AUDILENS LLK
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ESD
1994-08-22
SIEMENS BTE HEARING AIDS
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ESD
1994-08-18
MO6 SERIES
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ESD
1994-08-17
SM-VEGA, SM-PC, SM-AGC, SM-AGC-H
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ESD
1994-08-17
MIRACLE EAR MODEL PGM
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ESD
1994-08-17
MIRACLE-EAR MODEL PGC
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ESD
1994-08-17
MIRACLE-EAR MODEL PGF + REMOTE
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ESD
1994-08-09
PHILIPS M38 SERIES
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ESD
1994-08-09
CRYSTAL EAR
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ESD
1994-08-09
THE CANAL (C.I.C.) AKA/HIDDEN EAR
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ESD
1994-08-09
STARKEY CE-8 TML, STARKEY CE-8 TMC AIR CONDUCTION HEARING AID
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ESD
1994-08-04
EARCRAFT HEARING AID
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ESD
1994-07-25
MIRACLE-EAR EAR IMPRESSION MATERIAL
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ESD
1994-07-20
AURIS CIC
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ESD
1994-07-20
HAE 2
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ESD
1994-07-20
HAE 3
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ESD
1994-07-20
HAE 1
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ESD
1994-07-18
HI-PRO/NOAH UNIVERSAL HEARING INSTRUMENT
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ESD
1994-07-05
STAR 42 PP SP STAR 42 DIGITALLY PROGRAMMABLE HEARING AID
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ESD
1994-06-29
SUPER-SIL
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ESD
1994-06-24
EUROSTAR SUPER, EUROSTAR VFC
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ESD
1994-06-24
HEARING TECH
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ESD
1994-06-17
OPTIMA WITH DELTA AMP
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ESD
1994-06-17
PHILIPS 61 SERIES
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ESD
1994-06-17
SHARP II HELIX HEARING AID
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ESD
1994-06-15
BELTONE INVISA
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ESD
1994-05-13
PHONAK SONO-FORTE 331X BTE HEARING INSTRUMENTS
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ESD
1994-05-13
PRO-CONNECT
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ESD
1994-05-12
SHARP II LOW PROFILE HEARING AID
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ESD
1994-05-12
SHARP II SEMI CONTOUR HEARING AID
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ESD
1994-05-12
SHARP II FULL CONTOUR
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ESD
1994-05-12
770-ATC
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ESD
1994-05-12
AUDIOTONE MODEL A-54SR
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ESD
1994-05-12
AUDIOTONE MODEL A-54
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ESD
1994-05-12
WAX GUARD OPTION
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ESD
1994-05-04
MINI PAK
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ESD
1994-05-04
INTRA S, INTRA SH
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ESD
1994-05-04
WIDEX S-21
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ESD
1994-05-04
BELTON MERIT (HEARING AID)
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ESD
1994-05-04
RIONET HEARING AID HB-37T
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ESD
1994-05-04
RIONET HEARING AID HB-54
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ESD
1994-05-04
STARKEY EUROLINE A SERIES
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ESD
1994-05-04
155 PP AGC-I
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ESD
1994-05-04
MIRACLE-EAR WITH POWER CIRCUIT OPTION
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ESD
1994-05-03
COMPLETELY IN THE CANAL
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ESD
1994-04-04
BEHIND THE EAR HEARING AID
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ESD
1994-04-01
OTOSONIC CF-2, CF-2 IC, CF-2 ANF, CF-2 WITH IMPROVED CLASS D (DELTA AMP)
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ESD
1994-04-01
BELTONE ODE AND BELTONE ODE VX; ODE CLEARVOICE IC AND BELTONE ODE VX CLEARVOICE IC; BELTONE ODE CLEARVOICE ANF AND
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ESD
1994-04-01
BELTONE OPERA/OPERA MHP/OPERA MAX
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ESD
1994-04-01
OTOSONIC ACS II D WITH SRR
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ESD
1994-04-01
PROFILE IC; PROFILE CLEARVOICE; PROFILE
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ESD
1994-04-01
OTOSONIC (OSI) LPS D; LPS D IC; LPS D ASP
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ESD
1994-03-25
LORI-CIC HEARING AID
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ESD
1994-03-24
OTOSONIC MINI PAS
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ESD
1994-03-22
AIR CONDUCTION HEARING AID, UNITRON IKON K & KD
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ESD
1994-03-21
MIRACLE-EAR CONFIDANTE
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ESD
1994-03-21
RIONET HEARING AID HB-53CI
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ESD
1994-03-21
AIR CONDUCTION HEARING AID: IKON PP
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ESD
1994-03-17
WIDEX R.C. 2 (REMOTE CONTROL)
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ESD
1994-03-07
MIRACLE-EAR ENTRE
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ESD
1994-03-04
PRIZM HEARING SYSTEM, MODEL POWER BTE
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ESD
1994-01-27
HEARING AIDS HB-36M, HB-36MS, HB-36MT, HI-67P, EXCEL-1000
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ESD
1994-01-26
PHONAK PICONET 232X-AZ BTE HEARING INSTRUMENT
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ESD
1994-01-21
NU.EAR SS-10 IN THE CANAL (ITC) HEARING AID
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ESD
1994-01-21
NU.EAR SD-1 IN THE EAR (ITE) HEARING AID
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ESD
1994-01-21
NU.EAR SS-1 IN THE EAR (ITE) HEARING AID
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ESD
1994-01-21
NU.EAR AE-1 IN THE EAR (ITE) HEARING AID
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ESD
1994-01-21
NU.EAR SD-3 IN THE CANAL (ITC) HEARING AID
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ESD
1994-01-21
NU.EAR SS-3 IN THE CANAL (ITC) HEARING AID
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ESD
1994-01-21
NU.EAR AE-2 IN THE CANAL (ITC) HEARING AID
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ESD
1994-01-21
NU.EAR SS-2 IN THE CANAL (ITC) HEARING AID
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ESD
1994-01-21
NU.EAR SD-2 IN-THE-CANAL (ITC) HEARING AID
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ESD
1994-01-21
NU-EAR SD-10 IN THE CANAL HEARING AID
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ESD
1994-01-13
BINAURAL HEARING AID
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ESD
1994-01-05
AUDIPHON, MODEL H-11
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ESD
1993-12-27
MICRO-TECH TRU CANAL
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ESD
1993-12-22
PRO FIT-CYBER II OPTION
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ESD
1993-12-15
SOUNDRIGHT, SHP
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ESD
1993-12-15
MIRACLE EAR MODEL SHARP II MICRO CANAL HEARING AID
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ESD
1993-12-15
MIRACLE EAR MODEL SHARP II CANAL
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ESD
1993-12-15
8260 SERIES 3M PROGRAMMABLE HEARING INSTRUMENTS
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ESD
1993-12-15
PAL (PERSONAL AMPLIFIER FOR LISTENING)
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ESD
1993-11-29
UNITRON MODEL IKON AGCO/ AOD
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ESD
1993-11-29
OMNI 2000 SERIES ITC HEARING AID
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ESD
1993-11-29
OMNI 2000 SERIES ITE HEARING AID
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ESD
1993-11-19
OTOSONIC ADVANCED FULL SHIELD (AFS)
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