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
1995-08-22
ESD
1995-08-15
AM 260 OHM
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ESD
1995-08-15
AM 260 PP
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ESD
1995-08-15
AM 260 K-AMP
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1995-08-15
Z35
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1995-08-15
Z24
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1995-08-15
Z22
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ESD
1995-08-07
SPI-SECRET PERSONAL INSTRUMENT CIC
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ESD
1995-07-28
HEARING AID
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ESD
1995-07-26
RESOUND PERSONAL HEARING SYSTEM BT250 MZ W/REMOTE CONTROL OPTION
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ESD
1995-07-26
PERSONAL PROGRAMMER 2000
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ESD
1995-07-21
DYNAMIC EQ/CLASS D
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ESD
1995-07-21
DB PUSH-PULL HEARING AID
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ESD
1995-07-21
MWCHAC 95 FS 12345
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ESD
1995-07-21
MWCHAC 95 C 12345
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ESD
1995-07-20
CUSTOM CANAL & FULL CONCHA INSTR (CLASS D CIR OPT)
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ESD
1995-07-11
GOLD CD ULTRA MINI CANAL - MODULE
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ESD
1995-07-06
OUTPUT COMPRESSION LIMITER WITH ACTIVE TONE CONTROL
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ESD
1995-07-06
CLASS D LINEAR WITH ACTIVE TONE CONTROL
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ESD
1995-07-06
WIDE DYNAMIC RANGE COMPRESSION WITH ACTIVE TONE CONTROL
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ESD
1995-07-03
LORI-A
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ESD
1995-06-30
FULL DYNAMIC RANGE COMPRESSION BEHIND THE EAR HEARING INSTRUMENT
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ESD
1995-06-30
BELTONE PETITE PLUS BELTONE PETITE PLUS CLEARVIOCE K
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ESD
1995-06-30
ACURA-EX
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ESD
1995-06-28
OTOSONIC (OSI) CF 10-K, 10-D
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ESD
1995-06-28
BELTONE COMPOSER 2000
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ESD
1995-06-21
IMPROVED MANHATTAN II
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ESD
1995-06-21
EXPANDER WITH ACTIVE TONE CONTROL
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ESD
1995-06-21
INPUT COMPRSSION LIMITER WITH ACTIVE TONE CONTROL
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ESD
1995-06-19
WIDEX MODEL LOGO 32 (L32)
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ESD
1995-06-05
PROGRAMMABLE TWO MEMORY, SINGLE BAND BEHIND THE EAR HEARING INSTRUMENT
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ESD
1995-06-05
SONAR CIC COMPLETELY IN-THE-CANAL HEARING DEVICE
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ESD
1995-06-02
RIONET HEARING AID HM-02
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ESD
1995-05-30
INTELIVENIENCE PROGRAMMABLE FULL DYNAMIC RANGE COMPRESSION BEHIND THE EAR HEARING INSTRUMENT
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ESD
1995-05-25
AUDIOTECH MODEL SPI
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ESD
1995-05-24
RIONET HM-02
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ESD
1995-05-15
THE MODEL ACAPPELLA IN THE EAR HEARING AID
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ESD
1995-05-12
RESOUND ED4-M MINI-CANAL PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION (RESOUND PHS ED4-M)
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ESD
1995-05-12
RESOUND ED4-C CANAL PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION (RESOUND PHS ED4-C)
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ESD
1995-04-27
RESOUND PERSONAL HEARING SYSTEM MODELS ED3A & ED3A/S W/REMONTE CONTROL OPTION
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ESD
1995-04-27
RESOUND PERSONAL HEARING SYSTEM MODELS BTP2 & BTP2/S W/REMOTE CONTROL OPTION
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ESD
1995-04-14
RESOUND PERSONAL HEARING SYSTEM BTP/S-A W/REMOTE CONTROL OPTION
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ESD
1995-04-14
RESOUND PERSONAL HEARING SYSTEM BT2/S SERIES W/REMOTE CONTROL OPTION
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ESD
1995-04-14
RESOUND PERSONAL HEARING SYSTEM ED3/S-E
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ESD
1995-04-14
RESOUND PERSONAL HEARING SYSTEM BT2/S-E
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ESD
1995-04-13
BELTONE COMPARAFIT
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ESD
1995-03-31
UNITRON MODEL ESTEEM
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ESD
1995-03-31
MIRACLE-EAR MODEL PM1/PM2 PROGRAMMABLE HEARING AID
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ESD
1995-03-31
MIRACLE-EAR MODEL PBS PROGRAMMABLE HEARING AID
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ESD
1995-03-31
MIRACLE-EAR MODEL PBM PROGRAMMABLE HEARING AID
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ESD
1995-03-31
SILVER ULTRA MINI CANAL
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ESD
1995-03-24
GOLD CD ULTRA MINI CANAL
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ESD
1995-03-24
GOLD K AMP ULTRA MINI CANAL
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ESD
1995-03-21
MEGA-SIL A-B
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ESD
1995-03-21
DYNA 231X
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ESD
1995-03-21
MAICO IN-THE-EAR MODEL RD-312 CIC
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ESD
1995-03-21
M-29 PP-PC, M-29 PP-O/PC
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ESD
1995-03-07
RESOUND(R) RESOURCE(TM)
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ESD
1995-02-27
OTICON/LOGIC
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ESD
1995-02-24
MATRICS IMPRESSION MATERIAL , SYSTEM
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ESD
1995-02-22
MICRO MINI PRIMO AGC, MICRO-MINI PRIMO S-AGC
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ESD
1995-02-08
RESOUND(R) PERSONAL HEARING SYSTEM ED-3 ENCORE
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ESD
1995-02-08
VIP
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ESD
1995-02-08
MAGIC EAR, ELAIN
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ESD
1995-01-30
UNITRON MODEL VISTA 1000 SIGMA, AIR CONDUCTION HEARING AID
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ESD
1995-01-30
MAICO IN-THE-EAR MODEL RD 201
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ESD
1995-01-30
LX-ITC
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ESD
1995-01-30
OTICON
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ESD
1995-01-27
3M(TM) EAR IMPRESSION MATERIAL
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ESD
1995-01-26
PHONAK SONO-FORTE 332X-AZ
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ESD
1995-01-26
UNITRON MODEL SOUNG F/S
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ESD
1995-01-24
3M MODEL 8233 HEARING INSTRUMENT
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ESD
1995-01-20
HORMANN HEARING INSTRUMENTS
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ESD
1995-01-19
RESOUND PERSONAL HEARING SYSTEMS MODIFICATION
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ESD
1995-01-18
SOUND SELECTOR ITE (SSI), BTE (SSB), MINI BTE( SSM)
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ESD
1995-01-05
SIEMENS 10A FACEPLATE WITH CIC INSTRUMENTS
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ESD
1994-12-30
EMSEE LABS MODEL C
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ESD
1994-12-30
EMSEE LABS MODE M
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ESD
1994-12-30
EMSEE LABS MODEL S
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ESD
1994-12-30
ORION PPM, PP, PP-D
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ESD
1994-12-29
EXPRESSION RX-12, ENHANCEMENT RX-34, ELITE RX-12
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ESD
1994-12-27
SIEMENS FRONTIER SERICE, MODELS S-1,S-2 AND S-3 MULTIPLE SITUATION, SINGLE CHANNEL PROGRAMMABLE INSTRUMENTS
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ESD
1994-12-27
AIR CONDUCTION HEARING AID
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ESD
1994-12-27
WIDEX MODEL LOGO 8S
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ESD
1994-12-27
MO4 SERIES
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ESD
1994-12-27
LIFESOUND MULTIPLE SITUATION, SINGLE CHANNEL PROGRAMMABLE INSTRUMENTS
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ESD
1994-12-23
IN-THE-EAR HEARING AID
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ESD
1994-12-23
WIDEX MODEL LOGO - L9
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ESD
1994-12-23
BTP-A HEARING SYSTEM
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ESD
1994-12-23
BEHIND THE EAR HEARING AID
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ESD
1994-12-21
FINETONE DISCEET CANAL
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ESD
1994-12-21
ACTIVE MODEL CIC
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ESD
1994-12-21
IMAGE
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ESD
1994-12-21
DEEP CANAL HEARING INSTRUMENT
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ESD
1994-12-14
ADOBE C.I.C
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ESD
1994-11-29
MICROSIL
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ESD
1994-11-22
HEARING AID (ACCESSORY)
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ESD
1994-11-16
MAGNATONE MODEL M PREWIRED FACEPLATE HEARING AID
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ESD
1994-11-15
COMPASS SOFTWARE MODULE
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ESD
1994-11-15
DANAVOX MODEL CIC
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