---
kind: "section"
citation: "21 C.F.R. § 874.3410"
title: "21"
number: "874.3410"
heading: "Combined acoustic and electrical external stimulation device for the relief of tinnitus."
url: "https://uscodex.org/cfr/21/874.3410"
---

# §874.3410. Combined acoustic and electrical external stimulation device for the relief of tinnitus.

- (a) **Identification.** A combined acoustic and electrical external stimulation device for the relief of tinnitus is a device that provides acoustic stimulation in the ear and external, electrical stimulation of sensory nerves to relieve tinnitus.
- (b) **Classification.** Class II (special controls). The special controls for this device are:
  - (1) Clinical performance testing must demonstrate performance as intended under anticipated conditions for use including the following:
    - (i) Evaluation of tinnitus symptoms using a validated method; and
    - (ii) **Evaluation of all adverse events.**
  - (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including the following:
    - (i) Verification of specified electrical stimulation parameters; and
    - (ii) Verification of specified acoustic stimulation parameters, including maximum output limits, distortion levels, and frequency response.
  - (3) Performance data must demonstrate the electromagnetic compatibility, battery safety, and electrical safety of the device.
  - (4) Software verification, validation, and hazard analysis must be performed.
  - (5) The patient-contacting components of the device must be demonstrated to be biocompatible.
  - (6) Human factors testing must demonstrate that users can successfully use the device in the intended use environment based solely on its labeling and instructions for use.
  - (7) Labeling must include the following:
    - (i) A statement that the device is intended to be prescribed by a healthcare professional with expertise in the evaluation and management of tinnitus;
    - (ii) Information regarding emotional, psychological, and physical considerations for patient selection; and
    - (iii) Device specifications, including the materials of patient-contacting components of the device, electrical output waveform, stimulation peak voltage and current, pulse duration, frequency, maximum current density, maximum phase charge, and power source.

## Notes

### Amendments

[91 FR 35140, June 10, 2026]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 51 FR 40389, Nov. 6, 1986, unless otherwise noted.

### Amendments

[91 FR 35140, June 10, 2026]