FDA 510(k) Ear, Nose & Throat Devices
FDA 510(k) Ear, Nose, Throat Devices - Regulatory Overview
FDA 510(k) ear, nose and throat (ENT) devices cover diagnostic and therapeutic equipment used in otolaryngology. The FDA review panel code is EN.
This category includes:
- Hearing aids and amplifiers - air conduction, bone conduction and CROS systems
- Cochlear implants - Class III devices (typically PMA, some 510k predicate paths)
- ENT endoscopes - rigid and flexible nasopharyngoscopes, laryngoscopes
- Surgical instruments - microdebriders, powered ENT systems
- Audiometric systems - audiometers, tympanometers, OAE devices
3823
Total
3806
Cleared
164d
Avg (2y)
1976
Since
3186 Ear, Nose, Throat devices
Cleared
Dec 30, 1994
ORION PPM, PP, PP-D
ESD
Hearing Aid, Air-conduction, Prescription
94d
Cleared
Dec 30, 1994
EMSEE LABS MODEL S
ESD
Hearing Aid, Air-conduction, Prescription
79d
Cleared
Dec 30, 1994
EMSEE LABS MODE M
ESD
Hearing Aid, Air-conduction, Prescription
79d
Cleared
Dec 30, 1994
EMSEE LABS MODEL C
ESD
Hearing Aid, Air-conduction, Prescription
79d
Cleared
Dec 29, 1994
EXPRESSION RX-12, ENHANCEMENT RX-34, ELITE RX-12
ESD
Hearing Aid, Air-conduction, Prescription
113d
Cleared
Dec 27, 1994
LIFESOUND MULTIPLE SITUATION, SINGLE CHANNEL PROGRAMMABLE INSTRUMENTS
ESD
Hearing Aid, Air-conduction, Prescription
123d
Cleared
Dec 27, 1994
MO4 SERIES
ESD
Hearing Aid, Air-conduction, Prescription
110d
Cleared
Dec 27, 1994
WIDEX MODEL LOGO 8S
ESD
Hearing Aid, Air-conduction, Prescription
102d
Cleared
Dec 27, 1994
AIR CONDUCTION HEARING AID
ESD
Hearing Aid, Air-conduction, Prescription
102d
Cleared
Dec 27, 1994
SIEMENS FRONTIER SERICE, MODELS S-1,S-2 AND S-3 MULTIPLE SITUATION, SINGLE CHANNEL PROGRAMMABLE INSTRUMENTS
ESD
Hearing Aid, Air-conduction, Prescription
97d
Cleared
Dec 27, 1994
NERVE MONITOR ELECTRODES/STIMULATOR PROBES
ETN
Stimulator, Nerve
61d
Cleared
Dec 23, 1994
BEHIND THE EAR HEARING AID
ESD
Hearing Aid, Air-conduction, Prescription
127d
Cleared
Dec 23, 1994
BTP-A HEARING SYSTEM
ESD
Hearing Aid, Air-conduction, Prescription
127d
Cleared
Dec 23, 1994
WIDEX MODEL LOGO - L9
ESD
Hearing Aid, Air-conduction, Prescription
51d
Cleared
Dec 23, 1994
IN-THE-EAR HEARING AID
ESD
Hearing Aid, Air-conduction, Prescription
32d
Cleared
Dec 21, 1994
DEEP CANAL HEARING INSTRUMENT
ESD
Hearing Aid, Air-conduction, Prescription
196d
Cleared
Dec 21, 1994
IMAGE
ESD
Hearing Aid, Air-conduction, Prescription
117d
Cleared
Dec 21, 1994
BIO-LOGIC EMAV EMISSION AVERAGING OTOACOUSTIC TEST
EWO
Audiometer
86d
Cleared
Dec 21, 1994
BRONCHOSCOPE,NON-RIGID
EOQ
Bronchoscope (flexible Or Rigid)
71d
Cleared
Dec 21, 1994
ACTIVE MODEL CIC
ESD
Hearing Aid, Air-conduction, Prescription
56d
Cleared
Dec 21, 1994
KARL STORZ SUCTYION/IRRIGATION TUBES, CANNULAE
EOX
Esophagoscope (flexible Or Rigid)
55d
Cleared
Dec 21, 1994
FINETONE DISCEET CANAL
ESD
Hearing Aid, Air-conduction, Prescription
26d
Cleared
Dec 14, 1994
ADOBE C.I.C
ESD
Hearing Aid, Air-conduction, Prescription
173d
Cleared
Dec 09, 1994
INHEALTH BLOM-SINGER INDWELLING VALVED INSERT ACCESSORY DEVICE
EWL
Prosthesis, Laryngeal (taub)
39d
Cleared
Dec 02, 1994
INHEALTH BLOM-SINGER INDWELLING PLUG INSERT ACCESSORY DEVICE
EWL
Prosthesis, Laryngeal (taub)
32d
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