Federal Register #FDA-2026-N-6010

FDA Classifies Combined Acoustic and Electrical Stimulation Device for Tinnitus as Class II Medical Device

This notice announces a regulatory action by the Food and Drug Administration (FDA) regarding medical devices for tinnitus relief. - Government Buyer: - Department of Health and Human Services (HHS) - Food and Drug Administration (FDA) - Action: Final order classifying combined acoustic and electrical external stimulation devices for tinnitus as Class II medical devices - Device Description: - Provides acoustic stimulation in the ear - Provides external electrical stimulation of sensory nerves - Intended for relief of tinnitus - Regulatory Requirements: - Subject to special controls for safety and effectiveness - Special controls include: - Clinical and non-clinical performance testing - Software validation - Biocompatibility evaluation - Human factors testing - Specific labeling requirements - No OEMs, vendors, part numbers, or purchase quantities are specified - This is a regulatory classification, not a procurement or solicitation for products or services

Description

The Food and Drug Administration (FDA) is classifying the combined acoustic and electrical external stimulation device for the relief of tinnitus into class II (special controls). This classification provides reasonable assurance of safety and effectiveness of the device and aims to enhance patient access to innovative devices by reducing regulatory burdens. The device provides acoustic stimulation in the ear and external electrical stimulation of sensory nerves to relieve tinnitus. Special controls include clinical and non-clinical performance testing, software validation, biocompatibility evaluation, human factors testing, and specific labeling requirements.

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