Home
gpo.gov
govinfo.gov

e-CFR Navigation Aids

Browse

Simple Search

Advanced Search

 — Boolean

 — Proximity

 

Search History

Search Tips

Corrections

Latest Updates

User Info

FAQs

Agency List

Incorporation By Reference

eCFR logo

Related Resources

Electronic Code of Federal Regulations

We invite you to try out our new beta eCFR site at https://ecfr.federalregister.gov. We have made big changes to make the eCFR easier to use. Be sure to leave feedback using the Feedback button on the bottom right of each page!

e-CFR data is current as of April 13, 2021

Title 21Chapter ISubchapter HPart 874 → Subpart B


Title 21: Food and Drugs
PART 874—EAR, NOSE, AND THROAT DEVICES


Subpart B—Diagnostic Devices


Contents
§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.

return arrow Back to Top

§874.1050   Audiometer.

(a) Identification. An audiometer or automated audiometer is an electroacoustic device that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders.

(b) Classification. Class II. Except for the otoacoustic emission device, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, if it is in compliance with American National Standard Institute S3.6-1996, “Specification for Audiometers,” and subject to the limitations in §874.9.

[51 FR 40389, Nov. 6, 1986, as amended at 64 FR 14831, Mar. 29, 1999]

return arrow Back to Top

§874.1060   Acoustic chamber for audiometric testing.

(a) Identification. An acoustic chamber for audiometric testing is a room that is intended for use in conducting diagnostic hearing evaluations and that eliminates sound reflections and provides isolation from outside sounds.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §874.9.

[51 FR 40389, Nov. 6, 1986, as amended at 61 FR 1121, Jan. 16, 1996; 66 FR 38800, July 25, 2001]

return arrow Back to Top

§874.1070   Short increment sensitivity index (SISI) adapter.

(a) Identification. A short increment sensitivity index (SISI) adapter is a device used with an audiometer in diagnostic hearing evaluations. A SISI adapter provides short periodic sound pulses in specific small decibel increments that are intended to be superimposed on the audiometer's output tone frequency.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to §874.9.

[55 FR 48440, Nov. 20, 1990, as amended at 65 FR 2315, Jan. 14, 2000]

return arrow Back to Top

§874.1080   Audiometer calibration set.

(a) Identification. An audiometer calibration set is an electronic reference device that is intended to calibrate an audiometer. It measures the sound frequency and intensity characteristics that emanate from an audiometer earphone. The device consists of an acoustic cavity of known volume, a sound level meter, a microphone with calibration traceable to the National Bureau of Standards, oscillators, frequency counters, microphone amplifiers, and a recorder. The device can measure selected audiometer test frequencies at a given intensity level, and selectable audiometer attenuation settings at a given test frequency.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §874.9.

[51 FR 40389, Nov. 6, 1986, as amended at 61 FR 1121, Jan. 16, 1996; 66 FR 38800, July 25, 2001]

return arrow Back to Top

§874.1090   Auditory impedance tester.

(a) Identification. An auditory impedance tester is a device that is intended to change the air pressure in the external auditory canal and measure and graph the mobility characteristics of the tympanic membrane to evaluate the functional condition of the middle ear. The device is used to determine abnormalities in the mobility of the tympanic membrane due to stiffness, flaccidity, or the presence of fluid in the middle ear cavity. The device is also used to measure the acoustic reflex threshold from contractions of the stapedial muscle, to monitor healing of tympanic membrane grafts or stapedectomies, or to monitor followup treatment for inflammation of the middle ear.

(b) Classification. Class II (special controls). The device, when it is a tympanometer or auditory impedance tester that complies with FDA-recognized consensus standard ANSI S3.39, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §874.9.

[51 FR 40389, Nov. 6, 1986, as amended at 84 FR 71813, Dec. 30, 2019]

return arrow Back to Top

§874.1100   Earphone cushion for audiometric testing.

(a) Identification. An earphone cushion for audiometric testing is a device that is used to cover an audiometer earphone during audiometric testing to provide an acoustic coupling (sound connection path) between the audiometer earphone and the patient's ear.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to §874.9.

[51 FR 40389, Nov. 9, 1986; 52 FR 18495, May 15, 1987, as amended at 52 FR 32111, Aug. 25, 1987; 65 FR 2315, Jan. 14, 2000]

return arrow Back to Top

§874.1120   Electronic noise generator for audiometric testing.

(a) Identification. An electronic noise generator for audiometric testing is a device that consists of a swept frequency generator, an amplifier, and an earphone. It is intended to introduce a masking noise into the non-test ear during an audiometric evaluation. The device minimizes the non-test ear's sensing of test tones and signals being generated for the ear being tested.

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §874.9.

[51 FR 40389, Nov. 6, 1986, as amended at 84 FR 71813, Dec. 30, 2019]

return arrow Back to Top

§874.1325   Electroglottograph.

(a) Identification. An electroglottograph is an AC-powered device that employs a pair of electrodes that are placed in contact with the skin on both sides of the larynx and held in place by a collar. It is intended to measure the electrical impedance of the larynx to aid in assessing the degree of closure of the vocal cords, confirm larygeal diagnosis, aid behavioral treatment of voice disorders, and aid research concerning the laryngeal mechanism.

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §874.9.

[51 FR 40389, Nov. 6, 1986, as amended at 84 FR 71813, Dec. 30, 2019]

return arrow Back to Top

§874.1500   Gustometer.

(a) Identification. A gustometer is a battery-powered device that consists of two electrodes that are intended to be placed on both sides of the tongue at different taste centers and that provides a galvanic stimulus resulting in taste sensation. It is used for assessing the sense of taste.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to §874.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of §820.180 of this chapter, with respect to general requirements concerning records, and §820.198 of this chapter, with respect to complaint files.

[51 FR 40389, Nov. 6, 1986, as amended at 65 FR 2316, Jan. 14, 2000]

return arrow Back to Top

§874.1600   Olfactory test device.

(a) Identification. An olfactory test device is used to determine whether an olfactory loss is present. The device includes one or more odorants that are presented to the patient's nose to subjectively assess the patient's ability to perceive odors.

(b) Classification. Class II (special controls). The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: Olfactory Test Device.” For the availability of this guidance document, see §874.1(e). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §874.9. When indicated for the screening or diagnosis of diseases or conditions other than the loss of olfactory function, the device is not exempt from premarket notification procedures.

[71 FR 32835, June 7, 2006]

return arrow Back to Top

§874.1800   Air or water caloric stimulator.

(a) Identification. An air or water caloric stimulator is a device that delivers a stream of air or water to the ear canal at controlled rates of flow and temperature and that is intended for vestibular function testing of a patient's body balance system. The vestibular stimulation of the semicircular canals produce involuntary eye movements that are measured and recorded by a nystagmograph.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to §874.9.

[55 FR 48440, Nov. 20, 1990, as amended at 65 FR 2316, Jan. 14, 2000]

return arrow Back to Top

§874.1820   Surgical nerve stimulator/locator.

(a) Identification. A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.

(b) Classification. Class II.

return arrow Back to Top

§874.1925   Toynbee diagnostic tube.

(a) Identification. The toynbee diagnostic tube is a listening device intended to determine the degree of openness of the eustachian tube.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to §874.9.

[51 FR 40389, Nov. 6, 1986, as amended at 65 FR 2316, Jan. 14, 2000]

return arrow Back to Top

Need assistance?