21 CFR Part 874 — Ear, Nose, and Throat Devices
Subpart A — General Provisions
Subpart B — Diagnostic Devices
- § 874.1050— Audiometer.
- § 874.1060— Acoustic chamber for audiometric testing.
- § 874.1070— Short increment sensitivity index (SISI) adapter.
- § 874.1080— Audiometer calibration set.
- § 874.1090— Auditory impedance tester.
- § 874.1100— Earphone cushion for audiometric testing.
- § 874.1120— Electronic noise generator for audiometric testing.
- § 874.1325— Electroglottograph.
- § 874.1500— Gustometer.
- § 874.1600— Olfactory test device.
- § 874.1800— Air or water caloric stimulator.
- § 874.1820— Surgical nerve stimulator/locator.
- § 874.1925— Toynbee diagnostic tube.
Subpart D — Prosthetic Devices
- § 874.3300— Air-conduction hearing aid.
- § 874.3302— Bone-conduction hearing aid.
- § 874.3305— Wireless air-conduction hearing aid.
- § 874.3310— Hearing aid calibrator and analysis system.
- § 874.3315— Tympanic membrane contact hearing aid.
- § 874.3320— Group hearing aid or group auditory trainer.
- § 874.3325— Self-fitting air-conduction hearing aid.
- § 874.3330— Master hearing aid.
- § 874.3340— Active implantable bone conduction hearing system.
- § 874.3375— Battery-powered artificial larynx.
- § 874.3400— Tinnitus masker.
- § 874.3430— Middle ear mold.
- § 874.3450— Partial ossicular replacement prosthesis.
- § 874.3495— Total ossicular replacement prosthesis.
- § 874.3540— Prosthesis modification instrument for ossicular replacement surgery.
- § 874.3620— Ear, nose, and throat synthetic polymer material.
- § 874.3695— Mandibular implant facial prosthesis.
- § 874.3730— Laryngeal prosthesis (Taub design).
- § 874.3760— Sacculotomy tack (Cody tack)
- § 874.3820— Endolymphatic shunt.
- § 874.3850— Endolymphatic shunt tube with valve.
- § 874.3880— Tympanostomy tube.
- § 874.3900— Nasal dilator.
- § 874.3930— Tympanostomy tube with semipermeable membrane.
- § 874.3950— Transcutaneous air conduction hearing aid system.
Subpart E — Surgical Devices
- § 874.4100— Epistaxis balloon.
- § 874.4140— Ear, nose, and throat bur.
- § 874.4175— Nasopharyngeal catheter.
- § 874.4180— Eustachian tube balloon dilation system.
- § 874.4250— Ear, nose, and throat electric or pneumatic surgical drill.
- § 874.4350— Ear, nose, and throat fiberoptic light source and carrier.
- § 874.4420— Ear, nose, and throat manual surgical instrument.
- § 874.4450— Powered insertion system for a cochlear implant electrode array.
- § 874.4490— Argon laser for otology, rhinology, and laryngology.
- § 874.4500— Ear, nose, and throat microsurgical carbon dioxide laser.
- § 874.4680— Bronchoscope (flexible or rigid) and accessories.
- § 874.4710— Esophagoscope (flexible or rigid) and accessories.
- § 874.4720— Mediastinoscope and accessories.
- § 874.4750— Laryngostroboscope.
- § 874.4760— Nasopharyngoscope (flexible or rigid) and accessories.
- § 874.4770— Otoscope.
- § 874.4780— Intranasal splint.
- § 874.4800— Bone particle collector.
Subpart F — Therapeutic Devices
- § 874.5220— Ear, nose, and throat drug administration device.
- § 874.5300— Ear, nose, and throat examination and treatment unit.
- § 874.5350— Suction antichoke device.
- § 874.5370— Tongs antichoke device.
- § 874.5550— Powered nasal irrigator.
- § 874.5800— External nasal splint.
- § 874.5840— Antistammering device.
- § 874.5900— External upper esophageal sphincter compression device.