FDA 21 CFR Part 874 Ear, Nose and Throat Devices

FDA 21 CFR Part 874 Ear, Nose and Throat Devices

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Table of contents

Subpart A - General Provisions

874.1 Scope.

874.3 Effective dates of requirement for premarket approval.

874.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

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 C [Reserved]

Subpart D - Prosthetic Devices

874.3300 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, (and)

Subpart F - Therapeutic Devices

FDA 21 CFR Part 874 Ear, Nose and Throat Devices:

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