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
1991-05-09
ESD
1991-05-09
NHS 2009SP HEARING AID
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ESD
1991-05-07
STARKEY TRILOGY PROGRAM HEAR AID CC/CE MODELS
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ESD
1991-04-19
ULTRA & ULTRA LITE II, MODIFICATION
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ESD
1991-04-19
ELEGANCE - DEO, MODIFICATION
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ESD
1991-04-19
ADJUSTRETTE - DAO, MODIFICATION
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ESD
1991-04-19
CUSTOM PERSONAL EAR - CPE
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ESD
1991-04-17
PHONAK 9100 SC-AF ITE HEARING INSTRUMENT
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ESD
1991-04-17
PHONAK 9800 SC-AF ITE HEARING INSTRUMENT
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ESD
1991-04-15
PHONAK 9300 SC-AF ITE HEARING INSTRUMENT
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ESD
1991-04-15
AHL, ITE MODEL AMERICAN
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ESD
1991-04-09
MODEL FT40 TRANSONIC(TM) HEARING AID
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ESD
1991-04-03
ELECTONE ITE MODEL PREMIER
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ESD
1991-04-03
RESORBABLE BONE PLUG
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ESD
1991-03-21
DAHLBERG MODEL LZ BTE HEARING AID
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ESD
1991-03-21
DAHLBERG MODEL LG BTE HEARING AID
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ESD
1991-03-21
DAHLBERG MODEL LU BTE HEARING AID
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ESD
1991-03-21
DAHLBERG MODEL LT BTE HEARING AID
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ESD
1991-03-21
DAHLBERG MODEL LB BEHIND-THE-EAR HEARING AID
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ESD
1991-03-18
C ABRA MODEL LINEAR, LOW DR. CUSTOM CANAL HEAR AID
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ESD
1991-03-18
ABRA IPC MODEL INPUT COMPRES AGCCUST ITE HEAR AID
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ESD
1991-03-18
C ABRA MODEL LINEAR, LOW DRAIN CUST CANAL HEAR AID
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ESD
1991-03-18
ABRA MODEL LINE LOW DRAIN CUST IN-THE-EAR HEAR AID
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ESD
1991-03-18
CUSTOM ITE HEARING AID
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ESD
1991-03-15
ITE HEARING AID
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ESD
1991-03-15
MATRICS
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ESD
1991-03-13
3M MODEL 8240 ITE HEARING AID
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ESD
1991-03-08
POST AURICULAR HEARING AID MODEL PICO SC-H
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ESD
1991-03-08
543 SERIES BTE
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ESD
1991-02-28
3M MODEL 8245 ITE HEARING AID
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ESD
1991-02-28
3M MODEL 8244 ITE HEARING AID
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ESD
1991-02-28
3M MODEL 8243 ITE HEARING AID
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ESD
1991-02-28
3M MODEL 8242 ITE HEARING AID
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ESD
1991-02-28
3M MODEL 8241 ITE HEARING AID
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ESD
1991-02-28
PHILIPS MODEL S46-O BTE HEARING AID
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ESD
1991-02-28
PHILIPS MODEL S46-OL BTE HEARING AID
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ESD
1991-02-28
ACTIVE MODEL AHX HELIX ITE HEARING AID
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ESD
1991-02-28
ACTIVE MODEL AMC MINI CANAL ITE HEARING AID
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ESD
1991-02-28
ACTIVE MODEL ACA CUSTOM CANAL ITE HEARING AID
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ESD
1991-02-28
ACTIVE MODEL AHS HALF SHELL ITE HEARING AID
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ESD
1991-02-28
ACTIVE MODEL ALP LOW PROFILE ITE HEARING AID
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ESD
1991-02-28
ACTIVE MODEL AST CUSTOM ITE HEARING AID
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ESD
1991-02-28
POST AURICULAR HEARING AID MODEL PICO-FORTE PP-SC
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ESD
1991-02-28
PHONAK MODEL PICO C-S-H-T, BTE HEARING AID
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ESD
1991-02-05
PHILIPS MODEL S47 BTE HEARING AID
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ESD
1991-01-29
AM130 AGC-O (BEHIND THE EAR) HEARING AID
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ESD
1991-01-29
ELECTONE BTE MODEL AM 130 HF
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ESD
1991-01-29
ELECTONE BTE MODEL AM 240 PPL
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ESD
1991-01-29
ELECTONE BTE MODEL AM 130 PP
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ESD
1991-01-29
ELECTONE BTE MODEL AM 130 D
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ESD
1991-01-29
ELECTONE BTE MODEL AM 240 HF
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ESD
1991-01-29
ELECTONE BTE MODEL AM900 PP
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ESD
1991-01-28
ELECTONE BTE MODEL AM 240 PPI
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ESD
1991-01-28
143 SERIES BTE
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ESD
1991-01-28
133 SERIES BTE
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ESD
1990-12-28
MEMORYMATE MODEL 8270 ITE HEARING AID
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ESD
1990-12-21
HEARSET TELEPHONE HEARING SYSTEM
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ESD
1990-12-17
QUALITONE ITE GENESIS
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ESD
1990-12-17
MEMORYMATE HEARING AID WITH PMC PROGRAMMER
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ESD
1990-12-07
QUALITONE ULTRA CANAL GENESIS
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ESD
1990-12-07
HEARING AID, UNITRON MODEL UM60-UH
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ESD
1990-11-09
BEST LABS MODEL C
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ESD
1990-11-09
BEST LABS MODEL S
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ESD
1990-11-09
BEST LABS MODEL M
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ESD
1990-11-09
BEST LABS MODEL P
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ESD
1990-11-01
OTICAON BTE MODEL E34P
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ESD
1990-10-31
PRIZM HEARING SYSTEM
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ESD
1990-10-09
ITE HEARING AID, SOUND MED AMETHYST MODEL
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ESD
1990-10-09
ITE HEARING AID, PEARL MODEL
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ESD
1990-10-09
ITE HEARING AID, SOUND MED OPAL MODEL
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ESD
1990-10-09
ITE HEARING AID, SOUND MED RUBY MODEL
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ESD
1990-10-09
ITE HEARING AID, SOUND MED GOLDEN NUGGET MODEL
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ESD
1990-10-09
ITE HEARING AID, SAAPHIRE MODEL
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ESD
1990-10-09
ITE HEARING AID, DIAMOND MODEL
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ESD
1990-10-09
SERIES MCAXX (MODEL 851) ITE HEARING AID
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ESD
1990-10-09
AUDIOTECH MODEL DB
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ESD
1990-10-09
AUDIOTECH MODEL CL
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ESD
1990-10-09
ITE HEARING AID, SOUND MED EMERALD MODEL
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ESD
1990-10-09
MODIFIED HEARING AID (IN-THE-EAR)
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ESD
1990-10-05
MODEL TRITON 3000 BTE HEARING AID AND PMC SYSTEM
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ESD
1990-09-12
DYNASTY HEARING SYSTEMS INSTRUMENT
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ESD
1990-09-05
ESCORT ITC
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ESD
1990-08-10
VISTA - MODELS V12, V20, V23, V38, ITE HEARING AID
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ESD
1990-08-09
CE-8 CUSTOM IN-THE-EAR HEARING AIDS
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ESD
1990-08-01
ITE HEARING AID MODEL PALOMINO
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ESD
1990-07-27
HERITAGE III (HTC) ITC TYPE HEARING AID
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ESD
1990-07-27
REXTON RX12 POWER PLUS W/DUAL RECEIVER
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ESD
1990-07-20
INTRA III AND INTRA IV HEARING AIDS
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ESD
1990-07-09
ADAM MARK II CUSTOM IN-THE-EAR HEARING AID
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ESD
1990-07-09
CUSTOM IN-THE-EAR HEARING AID OTICON MODEL: P
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ESD
1990-06-14
CUSTOM ITE HEARING AID MODELS F AND L
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ESD
1990-06-14
CUSTOM ITE HEARING AID MODEL: H
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ESD
1990-06-14
CUSTOM ITE HEARING AID MODELS C AND M
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ESD
1990-05-29
AUDIOTONE ITE HEARING AID MODEL ZA (MICRO)
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ESD
1990-05-29
AUDIOTONE ITE HEARING AID MODEL ZG (MIRAGE)
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ESD
1990-05-29
AUDIOTONE ITE HEARING AID MODEL ZD (XT)
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ESD
1990-05-29
AUDIOTONE MODEL A-52S BEHIND-THE-EAR HEARING INST.
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ESD
1990-05-23
WIDEX HEARING AID MODEL THE DISCOVERY
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ESD
1990-05-23
MODEL 366 HEARING AID
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ESD
1990-05-23
BTE PICO SCD, PICO SC
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