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e-CFR data is current as of March 4, 2021

Title 21Chapter ISubchapter HPart 874Subpart D → §874.3730


Title 21: Food and Drugs
PART 874—EAR, NOSE, AND THROAT DEVICES
Subpart D—Prosthetic Devices


§874.3730   Laryngeal prosthesis (Taub design).

(a) Identification. A laryngeal prosthesis (Taub design) is a device intended to direct pulmonary air flow to the pharynx in the absence of the larynx, thereby permitting esophageal speech. The device is interposed between openings in the trachea and the esophagus and may be removed and replaced each day by the patient. During phonation, air from the lungs is directed to flow through the device and over the esophageal mucosa to provide a sound source that is articulated as speech.

(b) Classification. Class II (special controls). The device, when it is a voice amplification 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]

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