C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER H—MEDICAL DEVICES › PART 874—EAR, NOSE, AND THROAT DEVICES › Subpart D—Prosthetic Devices

21 C.F.R. § 874.3400

Tinnitus masker

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(a) Identification. A tinnitus masker is an electronic device intended to generate noise of sufficient intensity and bandwidth to mask ringing in the ears or internal head noises. Because the device is able to mask internal noises, it is also used as an aid in hearing external noises and speech.

(b) Classification. Class II. The special control for this device is patient labeling regarding:

(1) Hearing health care professional diagnosis, fitting of the device, and followup care,

(2) Risks,

(3) Benefits,

(4) Warnings for safe use, and

(5) Specifications.

[51 FR 40389, Nov. 6, 1986, as amended at 65 FR 17145, Mar. 31, 2000]
Notes of Decisions
Cited in 1 case, 2017–2017 · leading case: Academy of Doctors of Audiology v. Int'l Hearing Soc'y, 237 F. Supp. 3d 644 (E.D. Mich. 2017).
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Academy of Doctors of Audiology v. Int'l Hearing Soc'y, 237 F. Supp. 3d 644 (E.D. Mich. 2017). “Sound masking devices incorporated into hearing aids, or ‘Tinnitus Maskers,’ are likewise regulated by the FDA as a Class II Prosthetic Device, 21 CFR § 874.3400 . Tinnitus- Maskers may only be sold with patient labeling regarding ‘Hearing health care professional diagnosis,…”
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