21 CFR § 874.3310 - Hearing aid calibrator and analysis system.
---
identifier: "/us/cfr/t21/s874.3310"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 874.3310 - Hearing aid calibrator and analysis system."
title_number: 21
title_name: "Food and Drugs"
section_number: "874.3310"
section_name: "Hearing aid calibrator and analysis system."
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"
---
# 874.3310 Hearing aid calibrator and analysis system.
(a) *Identification.* A hearing aid calibrator and analysis system is an electronic reference device intended to calibrate and assess the electroacoustic frequency and sound intensity characteristics emanating from a hearing aid, master hearing aid, group hearing aid or group auditory trainer. The device consists of an acoustic complex of known cavity volume, a sound level meter, a microphone, oscillators, frequency counters, microphone amplifiers, a distoration analyzer, a chart recorder, and a hearing aid test box.
(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]