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
1992-09-10
ESD
1992-09-10
IN-THE-EAR HEARING AID
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ESD
1992-08-26
STARKEY SM SERIES BTE HEARING AIDS
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ESD
1992-08-24
VOICEWAVE
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ESD
1992-08-18
SIEMENS MODEL TRITON 3004 B
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ESD
1992-08-18
SIEMENS MODEL INFINITI 1001 B
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ESD
1992-08-11
PHILIP XP SERIES, IN-THE CANAL HEARING AID
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ESD
1992-08-06
BTE HEARING AID PERSONIC 425
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ESD
1992-08-06
BTE HEARING AID PERSONIC 410
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ESD
1992-08-06
BTE HEARING AID OTICON MODEL: MULTIFOCUS POWER
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ESD
1992-07-30
EURION LOTOS PP HEARING AID
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ESD
1992-07-10
ITE, ITC, OE(OPEN), HS(HALF SHELL) HEARING AID
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ESD
1992-07-06
A-ZILICONE
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ESD
1992-07-01
OTOSONIC ACS K
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ESD
1992-06-30
WIDEX MODEL D32
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ESD
1992-06-10
PROGRAMMABLE HEARING SYSTEM, ITE AND BTE TYPES
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ESD
1992-06-10
BELTONE OPERA CLEARVOICE IC, ITC (IN THE CANAL)
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ESD
1992-06-10
IN THE EAR HEARING AID
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ESD
1992-05-27
OTOSONIC ACS-IC
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ESD
1992-05-22
PHILIPS 31 SERIES IN THE EAR HEARING AID
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ESD
1992-05-18
TELEX MODEL 28A ITE CUSTOM HEARING AID
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ESD
1992-05-18
TELEX MODEL M29 ITE CUSTOM HEARING AID
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ESD
1992-05-15
EURION LOTOS P HEARING AID
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ESD
1992-05-08
LIFESOUND ITE (LSI-I)W/ TRITON 3004I PROGRAMMABLE
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ESD
1992-04-29
RIONET HEARING AID HB-52S
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ESD
1992-04-28
RIONET HEARING AID HB-52T
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ESD
1992-04-27
QCC CUSTOM CANAL AND QE1 ALL ITE
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ESD
1992-03-31
DI CUSTOM IN THE EAR AND IN THE CANAL
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ESD
1992-03-30
SOUNDCHOICE BTE
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ESD
1992-03-19
BELTONE OPRA CLEAR VOICE-K HEARING AID
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ESD
1992-03-19
RIONET HEARING AID - HB 52DU
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ESD
1992-03-12
AD-HEAR
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ESD
1992-03-12
HEARING AID (ALL-IN-THE-EAR)
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ESD
1992-02-27
EXTEND-EAR
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ESD
1992-02-27
IN THE EAR HEARING AID
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ESD
1992-02-19
RIONET HEARING AID HB-23M
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ESD
1992-02-19
RIONET HEARING AID HB-23T
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ESD
1992-02-19
AM 300 AGC-O
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ESD
1992-02-18
AM 300 XP
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ESD
1992-02-18
PREMIER K-AMP
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ESD
1992-02-18
PREMIER CLASS D-ASP
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ESD
1992-02-18
PREMIER CD RECHARGEABLE
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ESD
1992-02-18
PREMIER ASP/CD RECHARGEABLE
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ESD
1992-02-18
ELECTONE/PA RECHARGEABLE
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ESD
1992-02-14
RIONET HEARING AID HB-53P
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ESD
1992-01-30
AUDIOTONE MODEL A-96
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ESD
1992-01-24
PHILIPS 41 SERIES RAINBOW
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ESD
1992-01-24
BTE HEARING AID MULTIFOCUS
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ESD
1992-01-23
PHILIPS M60 SERIES
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ESD
1992-01-15
CUSTOM CANAL HEARING AID
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ESD
1992-01-13
RIONET HEARING AID HB-71K (K-AMP)
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ESD
1992-01-10
SONOTONE BEHIND THE EAR MODEL ST 54-0
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ESD
1992-01-09
REXTON RX34 WITH HORIZON PROGRAMMABLE OPTION
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ESD
1992-01-09
REXTON RX12 WITH HORIZON PROGRAMMABLE OPTION
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ESD
1992-01-09
SONOTONE BEHIND THE EAR MODEL ST 53A
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ESD
1992-01-09
SONOTONE BEHIND THE EAR MODEL ST 49
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ESD
1992-01-09
SONOTONE BODY AID MODEL ST 1000 BODY WORN
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ESD
1992-01-09
RIONET HEARING AID HB-52AS
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ESD
1992-01-09
MED-EQUIP CORPORATION
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ESD
1992-01-09
SONOTONE BEHIND THE EAR MODEL ST 45G
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ESD
1992-01-09
SONOTONE BEHIND THE EAR MODEL ST 47I
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ESD
1991-12-30
PHONAK 9000-AF ITE HEARING INSTRUMENT SERIES
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ESD
1991-12-05
PHILIPS P74P BEHIND-THE-EAR HEARING AID
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ESD
1991-11-27
BELTONE PROFILE IN-THE-EAR HEARING AID
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ESD
1991-11-27
OTOSONIC (OSI) LPS IN-THE-EAR HEARING AID
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ESD
1991-11-22
BELTONE CLEARVOICE
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ESD
1991-11-22
OTOSONIC ACS-ASP
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ESD
1991-11-05
P54 BTE HEARING AID
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ESD
1991-11-05
HEARING AID, UNITRON MODEL VISTA 4000
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ESD
1991-11-05
HEARING AID, UNITRON MODEL VISTA 3000
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ESD
1991-11-05
IN-THE-EAR HEARING AIDS
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ESD
1991-10-21
AUDIOTONE MODEL A-95 BEHIND-THE-EAR HEARING AID
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ESD
1991-10-21
ACT-II BEHIND THE EAR HEARING AID
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ESD
1991-10-18
MODEL 80 HEARING AID DISPENSING SYSTEM
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ESD
1991-10-11
SIEMENS MODEL LS-I W/INFINITI PROGRAMMABLE OPTION
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ESD
1991-09-23
UC312, ULTRA MINIATURE ITC HEARING AID
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ESD
1991-09-18
QUALITONE 48PP-AGC-I, BEHIND THE EAR HEARING AID
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ESD
1991-09-18
ELEGANCE - KED, BEHIND THE EAR HEARING AID
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ESD
1991-09-18
QUALITONE 46PP-AGC-I
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ESD
1991-09-06
PHONAK PICO-FORTE PP-C-P BTE HEARING INSTRUMENT
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ESD
1991-09-06
PHONAK AUDINET PP-C-P BTE HEARING INSTRUMENT
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ESD
1991-08-26
M32 IN-THE-EAR HEARING AID
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ESD
1991-08-26
PHILIPS S1594 OTB HEARING AID
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ESD
1991-07-31
HEARING AID, UNITRON MODEL UIK
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ESD
1991-07-24
SYSTEM BT W/REMOTE CONTROL OPTION HEARING AID
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ESD
1991-07-09
NHS 2044P BODY AID, HEARING AID
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ESD
1991-06-26
PHONAK PHONICA MODEL 312-SC ITE HEARING INSTRUMENT
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ESD
1991-06-26
PHONAK PHONICA MODEL 312-C ITE HEARING INSTRUMENT
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ESD
1991-06-26
SIEMENS MODEL 604 PP-L, BEHIND-THE-EAR HEARING AID
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ESD
1991-06-26
SIEMENS MODEL 604 PP, BEHIND-THE-EAR HEARING AID
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ESD
1991-06-20
TELEX MODEL TLP, IN-THE-EAR
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ESD
1991-06-17
QUALITONE MODEL 48 C-WR-BEHIND THE EAR
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ESD
1991-06-17
QUILTONE MODEL 48 PP-AGC-I-D-BEHIND THE EAR
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ESD
1991-06-07
PHILIPS M30 IN-THE-EAR HEARING AID
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ESD
1991-05-28
WIDEX MODEL QX IN-THE-EAR HEARING AID
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ESD
1991-05-17
STOCK CANAL, IN-THE-EAR HEARING AID
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ESD
1991-05-17
MODEL E-50, IN-THE-EAR HEARING AID
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ESD
1991-05-17
REGAL, BEHIND-THE-EAR HEARING AID
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ESD
1991-05-17
MODEL 800, BEHIND-THE-EAR HEARING AID
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ESD
1991-05-17
CHAMPION, BEHIND-THE-EAR HEARING AID
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