Home/CFR/Title 21/Part 874
FEDERAL · 21 CFR

Part 874 — Ear, Nose, and Throat Devices

67 sections · Title 21: Food and Drugs

§ 874.1Scope.
§ 874.3Effective dates of requirement for premarket approval.
§ 874.9Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
§ 874.1050Audiometer.
§ 874.1060Acoustic chamber for audiometric testing.
§ 874.1070Short increment sensitivity index (SISI) adapter.
§ 874.1080Audiometer calibration set.
§ 874.1090Auditory impedance tester.
§ 874.1100Earphone cushion for audiometric testing.
§ 874.1120Electronic noise generator for audiometric testing.
§ 874.1325Electroglottograph.
§ 874.1500Gustometer.
§ 874.1600Olfactory test device.
§ 874.1800Air or water caloric stimulator.
§ 874.1820Surgical nerve stimulator/locator.
§ 874.1925Toynbee diagnostic tube.
§ 874.3300Air-conduction hearing aid.
§ 874.3302Bone-conduction hearing aid.
§ 874.3305Wireless air-conduction hearing aid.
§ 874.3310Hearing aid calibrator and analysis system.
§ 874.3315Tympanic membrane contact hearing aid.
§ 874.3320Group hearing aid or group auditory trainer.
§ 874.3325Self-fitting air-conduction hearing aid.
§ 874.3330Master hearing aid.
§ 874.3340Active implantable bone conduction hearing system.
§ 874.3375Battery-powered artificial larynx.
§ 874.3400Tinnitus masker.
§ 874.3430Middle ear mold.
§ 874.3450Partial ossicular replacement prosthesis.
§ 874.3495Total ossicular replacement prosthesis.
§ 874.3540Prosthesis modification instrument for ossicular replacement surgery.
§ 874.3620Ear, nose, and throat synthetic polymer material.
§ 874.3695Mandibular implant facial prosthesis.
§ 874.3730Laryngeal prosthesis (Taub design).
§ 874.3760Sacculotomy tack (Cody tack)
§ 874.3820Endolymphatic shunt.
§ 874.3850Endolymphatic shunt tube with valve.
§ 874.3880Tympanostomy tube.
§ 874.3900Nasal dilator.
§ 874.3930Tympanostomy tube with semipermeable membrane.
§ 874.3950Transcutaneous air conduction hearing aid system.
§ 874.4100Epistaxis balloon.
§ 874.4140Ear, nose, and throat bur.
§ 874.4175Nasopharyngeal catheter.
§ 874.4180Eustachian tube balloon dilation system.
§ 874.4250Ear, nose, and throat electric or pneumatic surgical drill.
§ 874.4350Ear, nose, and throat fiberoptic light source and carrier.
§ 874.4420Ear, nose, and throat manual surgical instrument.
§ 874.4450Powered insertion system for a cochlear implant electrode array.
§ 874.4490Argon laser for otology, rhinology, and laryngology.
§ 874.4500Ear, nose, and throat microsurgical carbon dioxide laser.
§ 874.4680Bronchoscope (flexible or rigid) and accessories.
§ 874.4710Esophagoscope (flexible or rigid) and accessories.
§ 874.4720Mediastinoscope and accessories.
§ 874.4750Laryngostroboscope.
§ 874.4760Nasopharyngoscope (flexible or rigid) and accessories.
§ 874.4770Otoscope.
§ 874.4780Intranasal splint.
§ 874.4800Bone particle collector.
§ 874.5220Ear, nose, and throat drug administration device.
§ 874.5300Ear, nose, and throat examination and treatment unit.
§ 874.5350Suction antichoke device.
§ 874.5370Tongs antichoke device.
§ 874.5550Powered nasal irrigator.
§ 874.5800External nasal splint.
§ 874.5840Antistammering device.
§ 874.5900External upper esophageal sphincter compression device.