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
1993-11-19
ESD
1993-11-19
PROGRAMMABLE AIR CONDUCTION BEHIND THE EAR HEARING AID
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ESD
1993-11-19
RIONET HEARING AID HA-73
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ESD
1993-11-19
RIONET HEARING AID HA-72
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ESD
1993-11-03
RESOUND PORTABLE PRESCRIPTIVE PROGRAMMING SYSTEM
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ESD
1993-11-02
V-SIL
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ESD
1993-10-13
HI BAND
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ESD
1993-10-08
MANHATTAN II
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ESD
1993-10-08
3-CHANNEL CLOCK
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ESD
1993-10-08
MANHATTAN 3-CHANNEL
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ESD
1993-10-08
3-CHANNEL K-AMP
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ESD
1993-10-08
POWER 3-CHANNEL-CLOCK
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ESD
1993-10-08
LINEAR PLUS-POWER
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ESD
1993-10-08
POWER MANHATTAN II
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ESD
1993-10-08
K-AMP
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ESD
1993-10-08
2:1 INPUT COMPRESSION
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ESD
1993-10-08
LINEAR PLUS
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ESD
1993-10-07
RESOLUTION ITC HEARING AID
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ESD
1993-10-07
BOSCH EUROSTAR
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ESD
1993-10-07
STARKEY TYMPANETTE HEARING AID
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ESD
1993-09-18
AS-90
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ESD
1993-09-07
PHILIPS 45 SERIES
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ESD
1993-08-23
WIDEX MODEL LOGO 8 (L8)
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ESD
1993-08-23
WIDEX MODEL LOGO 6 (L6)
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ESD
1993-08-23
WIDEX MODEL LOGO 12 (L12)
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ESD
1993-08-23
MEMOREX ARTISAN SYSTEM/ARTISAN PROGRAMMER AND CUSTOM HEARING AID
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ESD
1993-08-23
MULTIFOCUS COMPACT BTE HEARING AID
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ESD
1993-08-23
MAICO BTE MODEL RD-111 AND ITE MODEL RD-312 HEARING AID
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ESD
1993-08-19
BELTONE PRIMA 2000
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ESD
1993-08-09
PRIZM HEARING SYSTEM
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ESD
1993-08-05
OTICON MF
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ESD
1993-08-02
SILVER COMPRESSION MODULE, ITE
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ESD
1993-08-02
GOLD ASP MODULE, ITE
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ESD
1993-07-27
STARKEY TRILOGY II PROGRAMMABLE HEARING AID
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ESD
1993-07-27
PHONAK PICO-FORTE SC-D-2
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ESD
1993-07-27
PHONAK PICO-FORTE SC-2
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ESD
1993-07-26
351-AGCO BEHIND-THE-EAR HEARING AID
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ESD
1993-07-20
RESOUND PERSONAL HEARING SYSTEM BT-P W/PHS BT-P
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ESD
1993-07-14
BELTONE OPERA/OPERA MHP/OPERA MAX
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ESD
1993-07-14
VINYL ADDITION SILICONE SYSTEM
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ESD
1993-07-08
PHONAK LEXA 231X ITE SERIES HEARING SINSTRUMENT
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ESD
1993-07-02
BELTONE OPTIMA 2000 ITE HEARING AID
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ESD
1993-07-02
IN THE CANAL AID OTOSONIC ACS II WITH SRR
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ESD
1993-06-24
M32 IN THE EAR HEARING AID
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ESD
1993-06-24
M30 IN THE EAR HEARING AID
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ESD
1993-06-22
AUDIOTECH MODEL DP
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ESD
1993-06-14
IN-THE-EAR HEARING AID
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ESD
1993-06-14
HEARING AIDS
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ESD
1993-06-08
PERFECT EAR/PE
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ESD
1993-06-01
SERIES STAR 22 - BEHIND THE EAR HEARING AID
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ESD
1993-06-01
SERIES STAR 66 BEKHIND THE EAR HEARING AID
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ESD
1993-06-01
STAR 42 PP-SP, STAR 42 PP-SL (T100)
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ESD
1993-06-01
MT 80 SP
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ESD
1993-06-01
MODELS 33PP, 33PP ANR, & 33PP SUPER HEARING AID
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ESD
1993-05-19
ITC MODEL ADOBE 100 CANAL
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ESD
1993-05-19
ITE MODEL ADOBE 100 FULL CUSTOM
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ESD
1993-05-05
RIONET HEARING AID HB-53W
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ESD
1993-05-05
IN-THE-EAR HEARING AID
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ESD
1993-04-14
MEMOREX MODEL 361-AGCO HEARING AID
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ESD
1993-04-14
BEHIND-THE-EAR HEARING AID, TELEX MODEL 380-PP
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ESD
1993-04-14
BEHIND-THE-EAR HEARING AID, TELEX MODEL 361-PP
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ESD
1993-04-12
SIEMENS MODEL 584-P-AI-D
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ESD
1993-04-12
SIEMENS MODEL 584-P-AI
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ESD
1993-04-12
SIEMENS MODEL 584-P-GC
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ESD
1993-04-07
RIONET HEARING AID HB-53S
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ESD
1993-04-07
HEARING AID (ALL-IN-THE-EAR)
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ESD
1993-03-18
INTRA V AND SECRET EAR III
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ESD
1993-03-18
CE-9 IN-THE-EAR HEARING AID
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ESD
1993-03-18
WIDEX MODEL DX HEARING AID
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ESD
1993-03-18
OTOSONIC FSD, IN-THE-EAR HEARING AID
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ESD
1993-03-18
BEHIND-THE-EAR HEARING AID
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ESD
1993-03-03
VOICEMODE, ITE, AIR-CONDUCTION HEARING AID
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ESD
1993-03-01
BELTONE OPERA LOR, ITC
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ESD
1993-03-01
BELTONE OPTIMA 2000 CLEARVOICE SERIES, IN-THE-EAR
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ESD
1993-02-12
MIRACLE-EAR MODEL HL
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ESD
1993-02-12
AUDIOTONE MODEL A-98
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ESD
1993-02-08
VISTA 4000 SIGMA
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ESD
1993-02-02
SOUNDCHOICE WITH VARIABLE SLOPE
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ESD
1993-02-02
WIDEX MODEL D16
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ESD
1993-02-01
PHONAK PICONET 231-X
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ESD
1993-01-27
WIDEX MODEL D8 (HEARING AID)
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ESD
1992-11-24
P54 HEARING AID
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ESD
1992-11-24
P54-0 BEHIND THE EAR HEARING AID
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ESD
1992-11-16
HEARING AID (ALL-IN-THE-EAR)
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ESD
1992-11-06
AAHS HEARING AID
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ESD
1992-11-04
PHONAK PICO-FORTE PPC-P-2 BTE HEARING INSTRUMENT
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ESD
1992-11-04
PHONAK PICO-FORTE PPC-L-P-2 BTE HEARING INSTR
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ESD
1992-11-04
PHONAK PICO-FORTE PP-SC-2 BTE HEARING INSTRUMENT
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ESD
1992-11-03
PHONAK PICO-FORTE C-2 BTE HEARING INSTRUMENT
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ESD
1992-11-03
DFS GENIUS BTE
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ESD
1992-10-05
MEDIPHONIX CUSTOM FULL SHELL CUSTOM CANAL
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ESD
1992-10-05
ITC HEARING AID CLUB MODEL LM50
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ESD
1992-09-28
RIONET HB75-AL BTE AID
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ESD
1992-09-28
BTE WITH ACCESSORY ATTACHED
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ESD
1992-09-28
SOUNDCHOICE K-AMP
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ESD
1992-09-28
DANPLEX DIAGNOSTIC AUDIOMETER, CLIN. DIAG. AUDIOMT
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ESD
1992-09-23
BTE HEARING AID CLUB MODEL ST70
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ESD
1992-09-23
ITC HEARING AID CLUB MODEL LM40
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ESD
1992-09-23
BTE HEARING AID CLUB MODEL: ST60
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ESD
1992-09-23
ITC HEARING AID CLUB MODEL LM50H
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