21 CFR 874.3410 — Combined Acoustic And Electrical External Stimulation Device For The Relief Of Tinnitus
Ear, Nose, Throat (EN) · Part 874 Subpart D—Prosthetic Devices · § 874.3410
Identification
The Lenire is a combined acoustic and electrical external stimulation device for the relief of tinnitus. It is intended to provide bimodal (sound and transmucosal electrical tongue) stimulation to temporarily relieve the symptoms of tinnitus in patients 18 years of age and older suffering from at least moderate tinnitus. The treatment is intended to be self-administered by the patient following prescription by a healthcare professional.
Classification Rationale
FDA has determined that the device can be classified in Class II with the establishment of special controls. Class II (special) controls provide reasonable assurance of the safety and effectiveness of the device type.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| QVN | Combined Acoustic And Electrical External Stimulation Device For The Relief Of Tinnitus | 2 | 1 | SaMD |
Special Controls
QVN — Combined Acoustic And Electrical External Stimulation Device For The Relief Of Tinnitus
In combination with the general controls of the FD&C Act, the combined acoustic and electrical external stimulation device for the relief of tinnitus is subject to the following special controls: (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.
De Novo Order DEN210033
