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
3812
Total
3795
Cleared
160d
Avg (2y)
1976
Since
2016 Ear, Nose, Throat devices
Cleared
Jul 20, 1995
STRYKER HUMMER II MICRODEBRIDER SYSTEM
ERL
Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece
38d
Cleared
Jul 12, 1995
BELTONE PERSONAL HEARING SCREENER
EWO
Audiometer
350d
Cleared
Jul 11, 1995
GOLD CD ULTRA MINI CANAL - MODULE
ESD
Hearing Aid, Air-conduction, Prescription
92d
Cleared
Jul 10, 1995
WELCH ALLY OTOSCOPE
ERA
Otoscope
35d
Cleared
Jul 03, 1995
KARL STORZ CATHETERS, ADAPTORS, SUCTION/IRRIGATION CATHETERS, TUBING
EOQ
Bronchoscope (flexible Or Rigid)
61d
Cleared
Jul 03, 1995
RICHARDS TORP
ETA
Replacement, Ossicular Prosthesis, Total
31d
Cleared
Jun 30, 1995
GROUP AUDITORY TRAINER (GROUP AMPLIFICATION SYSTEM)
EPF
Hearing Aid, Group And Auditory Trainer
134d
Cleared
Jun 30, 1995
BELTONE PETITE PLUS BELTONE PETITE PLUS CLEARVIOCE K
ESD
Hearing Aid, Air-conduction, Prescription
85d
Cleared
Jun 30, 1995
FULL DYNAMIC RANGE COMPRESSION BEHIND THE EAR HEARING INSTRUMENT
ESD
Hearing Aid, Air-conduction, Prescription
71d
Cleared
Jun 28, 1995
HORTMANN AIRMATIC AIR CALORIC STIMULATOR
KHH
Stimulator, Caloric-air
127d
Cleared
Jun 28, 1995
BELTONE COMPOSER 2000
ESD
Hearing Aid, Air-conduction, Prescription
121d
Cleared
Jun 28, 1995
SENSICARE SYNTHETIC, SURGICAL GLOVE LINER
LYN
Apparatus, Visual Reinforcement Audiometric
117d
Cleared
Jun 28, 1995
OTOSONIC (OSI) CF 10-K, 10-D
ESD
Hearing Aid, Air-conduction, Prescription
55d
Cleared
Jun 21, 1995
MICROFLOW IRRIGATION SYSTEM
KMA
Irrigator, Powered Nasal
162d
Cleared
Jun 19, 1995
WIDEX MODEL LOGO 32 (L32)
ESD
Hearing Aid, Air-conduction, Prescription
38d
Cleared
Jun 16, 1995
RICHARDS PORP
ETB
Prosthesis, Partial Ossicular Replacement
17d
Cleared
Jun 13, 1995
EAR-A-GATOR
KHH
Stimulator, Caloric-air
181d
Cleared
Jun 07, 1995
NASAL SEPTAL SPLINT
LYA
Splint, Intranasal Septal
28d
Cleared
Jun 05, 1995
KARL STORZ MICRO-INSTRUMENT FOR COCHLEAR IMPLANTATION
EQJ
Bur, Ear, Nose And Throat
158d
Cleared
Jun 05, 1995
SONAR CIC COMPLETELY IN-THE-CANAL HEARING DEVICE
ESD
Hearing Aid, Air-conduction, Prescription
25d
Cleared
Jun 05, 1995
PROGRAMMABLE TWO MEMORY, SINGLE BAND BEHIND THE EAR HEARING INSTRUMENT
ESD
Hearing Aid, Air-conduction, Prescription
21d
Cleared
Jun 02, 1995
RIONET HEARING AID HM-02
ESD
Hearing Aid, Air-conduction, Prescription
52d
Cleared
May 30, 1995
INTELIVENIENCE PROGRAMMABLE FULL DYNAMIC RANGE COMPRESSION BEHIND THE EAR HEARING INSTRUMENT
ESD
Hearing Aid, Air-conduction, Prescription
36d
Cleared
May 25, 1995
SIEMENS PC AUIDIOMETER MODEL SD 100 & PC PROBE MIC SYSTEM MODEL SD 110/SD WITH UNITY SOPFTWARE SUITE
ETW
Calibrator, Hearing Aid / Earphone And Analysis Systems
21d
Cleared
May 15, 1995
THE MODEL ACAPPELLA IN THE EAR HEARING AID
ESD
Hearing Aid, Air-conduction, Prescription
273d
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