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
1990-05-23
ESD
1990-05-23
BTE SUPER-FRONT PPSCL, SUPER-FRONT PPSC
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ESD
1990-05-23
PHONAK ITE 8000, 7000, 6000 ITE HEARING AID
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ESD
1990-05-23
MIRACLE EAR MODEL PC PROG. IN-THE-EAR HEARING AID
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ESD
1990-05-23
WIDEX BTE HEARING AID MODEL Q16 WITH REMOTE
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ESD
1990-05-21
SIEMENS MODEL 284 PP
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ESD
1990-05-21
SIEMENS MODEL 283 ASP
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ESD
1990-05-21
SIEMENS MODEL 284 PP-AGC
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ESD
1990-05-21
SIEMENS MODEL 284 PP-L
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ESD
1990-04-30
NICOLET DBTE HEARING AID: DIGITAL & PROGRAMMABLE
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ESD
1990-04-30
DISCRETION, IN THE CANAL HEARING INSTRUMENT
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ESD
1990-04-27
SEARS MODEL 9098 ITE HEARING AID
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ESD
1990-04-27
SEARS MODEL 9094 ITE HEARING AID
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ESD
1990-04-18
BTE HEARING AID, UNITRON MODELS US80PP AND US80PPL
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ESD
1990-04-18
AUDIOTONE MODEL FFI ITE HEARING AID
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ESD
1990-04-18
MODEL AUDINA ITE HEATING AID
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ESD
1990-04-18
EXAM GLOVES (VINYL) MFG. GLORIOUS WEALTH CO.
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ESD
1990-04-16
SEARS MODEL JCS IN-THE-EAR HEARING INSTRUMENT
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ESD
1990-04-16
SEARS MODEL LF9096 IN-THE-EAR HEARING INSTRUMENT
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ESD
1990-04-16
SEARS MODEL LC9092 IN-THE-EAR HEARING INSTRUMENT
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ESD
1990-04-16
SEARS MODEL LM9091 IN-THE-EAR HEARING INSTRUMENT
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ESD
1990-04-16
SEARS MODEL LI9097 IN-THE-EAR HEARING INSTRUMENT
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ESD
1990-04-16
AHAC ITE MODEL ENTENDRE
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ESD
1990-04-13
SEARS MODEL LS9093 IN-THE-EAR HEARING INSTRUMENT
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ESD
1990-04-13
DAHLBERG MODEL JM IN-THE-EAR HEARING INSTRUMENT
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ESD
1990-04-10
WIDEX MODEL Q12 BTE WITH QUATRO REMOTE CONTROL
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ESD
1990-04-10
WIDEX MODEL Q9, BTE W/QUATRO REMOTE CONTROL
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ESD
1990-04-10
OTICON BTE HEARING AID (BEHIND-THE-EAR), MODEL E44
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ESD
1990-04-10
HEARING AID (ALL-IN-THE-EAR)
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ESD
1990-04-04
DAHLBERG MODEL JH IN-THE-EAR HEARING INSTRUMENT
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ESD
1990-04-04
HEARING AID (ALL-IN-THE-EAR)
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ESD
1990-03-27
REXTON PP 142, PP 142-L
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ESD
1990-03-15
WIDEX HEARING AID MODEL ES 10 ASP T
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ESD
1990-03-15
WIDEX HEARING AID MODELS ES9T AND ES9H
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ESD
1990-03-14
DAHLBERG MODEL JMS IN-THE-EAR HEARING INSTRUMENT
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ESD
1990-03-14
MIRACLE EAR MODEL CK IN-THE-EAR HEARING AID
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ESD
1990-03-14
HEARING AID (ALL-IN-THE-EAR)
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ESD
1990-03-05
IN THE EAR HEARING AID
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ESD
1990-02-22
MIRACLE EAR MODEL SK IN-THE-EAR HEARING AID
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ESD
1990-02-22
MIRACLE EAR MODEL SM IN-THE-EAR HEARING AID
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ESD
1990-02-08
RESOUND CUSTOM IN-THE CANAL HEARING AID MODEL CA1
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ESD
1990-01-23
BESTONE MODEL ITE & CANAL
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ESD
1990-01-22
DAHLBERG MODEL LP BEHIND-THE-EAR HEARING AID
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ESD
1990-01-22
DAHLBERG MODEL LA BEHIND-THE-EAR HEARING AID
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ESD
1990-01-22
DAHLBERG MODEL LH BEHIND-THE-EAR HEARING AID
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ESD
1990-01-16
MINI PRIMO PLUS ASP BEHIND-THE-EAR HEARING AID
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ESD
1990-01-10
REXTON RX12D CUSTOM IN-THE-EAR HEARING AID
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ESD
1990-01-04
ITE HEARING AID MODEL PA
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ESD
1990-01-04
AURAL-TECH ITE HEARING AID MODEL AT-1S, 1SA, 1SC
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ESD
1990-01-04
ITC PRESCRIPTION SERIES MODEL CA AND C
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ESD
1989-11-03
FULL ITE, LOW PROFILE, HELIX, CANAL COMBIN/SD CANA
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ESD
1989-10-24
3M INSTANT FIT CUSTOM EARMOLD
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ESD
1989-10-24
HEARING AID (IN-THE-EAR)
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ESD
1989-10-11
CUSTOM IN-THE-CANAL (ITC) HEARING AID MODEL I54
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ESD
1989-09-27
HEARING AID (IN-THE-CANAL)
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ESD
1989-09-08
LORI-MODEL L, CANAL IN-THE-EAR INSTRUMENT
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ESD
1989-09-08
LORI-MODEL H, HALF CONCHA IN-THE-EAR INSTRUMENT
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ESD
1989-09-08
LORI-MODEL O, LOW PROFILE IN-THE EAR INSTRUMENT
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ESD
1989-08-15
OTICON I22P CUSTOM FULL CONCHA (ITE) HRNG AID
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ESD
1989-08-08
ASTRO BEHIND-THE-EAR HEARING AID
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ESD
1989-08-04
RESOUND CUSTOM IN-THE CANAL HEARING AID PHS-3
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ESD
1989-08-04
PERSONAL AMPLIFIER RECHARGEABLE MODEL TRIUMPH II
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ESD
1989-08-03
BEHIND-THE-EAR HEARING AID MODEL 48 AGCI
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ESD
1989-07-14
ITE PRESCRIPTION SERIES MODEL PP + F
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ESD
1989-07-14
ITE PRESCRIPTION SERIES MODEL LP
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ESD
1989-06-22
PHONIC EAR ITE/ITC HRNG AID 901, 902, 903, 906,911
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ESD
1989-06-16
ALPHA MODEL I ITE HEARING AID
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ESD
1989-06-14
PERSONAL AMPLIFIER MODEL ULTRA HELIX
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ESD
1989-06-06
TELSTAR MODEL PP ITE HEARING AID
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ESD
1989-06-06
TELSTAR MODEL C ITE HEARING AID
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ESD
1989-06-06
TELSTAR MODEL F ITE HEARING AID
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ESD
1989-06-06
TELSTAR MODEL 1/3 ITE HEARING AID
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ESD
1989-05-19
BEHIND-THE-EAR HEARING AID MODEL 48 PP PC
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ESD
1989-05-19
REXTON RX12PP, RX20PP & RX34PP IN-THE-EAR HEAR AID
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ESD
1989-05-19
INTERTON BTE HEAR AID, SUPRA, SUPREMA, MINETTA
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ESD
1989-05-11
ITC & ITE HEARING AID, HEAR CLEAR MODELS 1-4
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ESD
1989-05-10
BEHIND-THE-EAR HEARING AID MODEL 46 PP PC
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ESD
1989-05-10
CERUMEN FILTER
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ESD
1989-03-31
BEHIND-THE-EAR HEARING AID MODEL 408 W-H
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ESD
1989-03-29
BEHIND-THE-EAR HEARING AID MODEL 264 D-PP-PC
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ESD
1989-03-29
BEHIND-THE-EAR HEARING AID MODEL 303 ASP
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ESD
1989-03-29
BEHIND-THE-EAR HEARING AID MODEL 304 PP-AGC-I
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ESD
1989-03-29
RESOUND ITC HEARING ENHANCEMENT SYS HES2, W/REMOTE
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ESD
1989-03-29
ITE HEARING AID PARKER/TECHNITONE, MODEL PA
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ESD
1989-03-17
CUSTOM IN-THE-CANAL HEARING AID MODEL: I52A
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ESD
1989-03-09
BTE HEARING AID OTICON MODEL: E42P
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ESD
1989-03-01
WIDEX BTE HEARING AID MODEL Q8
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ESD
1989-02-22
RESOUND HES, DIGITALLY PROGR., ITE HEARING AID
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ESD
1989-01-18
BTE HEARING AID SIEMENS MODEL 284PP-ASP
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ESD
1989-01-13
ENSONIQ SOUND SELECTOR, BTE DIGITAL PROG. HRNG AID
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ESD
1989-01-03
HEARING AID, UNITRON BTE MODEL UM60-AGC0
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ESD
1988-12-19
HEARING AID WIDEX BTE
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ESD
1988-11-14
H.A.C. MODEL-B (ALL IN THE CANAL)
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ESD
1988-11-14
H.A.C. MODEL-A (ALL IN THE EAR)
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ESD
1988-10-31
UNIMAX(TM) HEARING AID BTE MODELS:100S, 110C, PPS4
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ESD
1988-09-22
ITE HEARING AID, SIEMENS MODEL 007, WITH TELOS
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ESD
1988-09-15
ITC-ITE TYPE HEAR AID/HEAR-O-INC MDL FAVORITE EAR
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ESD
1988-09-01
HEARING AID, UNITRON MODEL VISTA 1000
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ESD
1988-08-30
MODEL P4/P4X BEHIND-THE-EAR HEARING AID W/PHOX
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ESD
1988-08-26
ITE HEARING AID, EARTECH/CUSTOM AID MODEL CA
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