21 CFR § 874.3880 - Tympanostomy tube.

---
identifier: "/us/cfr/t21/s874.3880"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 874.3880 - Tympanostomy tube."
title_number: 21
title_name: "Food and Drugs"
section_number: "874.3880"
section_name: "Tympanostomy tube."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "874"
part_name: "EAR, NOSE, AND THROAT DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "51 FR 40389, Nov. 6, 1986, unless otherwise noted."
cfr_part: "874"
---


# 874.3880 Tympanostomy tube.

(a) *Identification.* A tympanostomy tube is a device that is intended to be implanted for ventilation or drainage of the middle ear. The device is inserted through the tympanic membrane to permit a free exchange of air between the outer ear and middle ear. A type of tympanostomy tube known as the malleous clip tube attaches to the malleous to provide middle ear ventilation. The device is made of materials such as polytetrafluoroethylene, polyethylene, silicon elastomer, or porous polyethylene.

(b) *Classification.* Class II.