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# Class 2 for Air-Conduction Hearing Aids
- URL: https://www.fdaweb.com/class-2-for-air-conduction-hearing-aids/
- Published: 2019-10-29T12:00:00.000Z
- Updated: 2026-09-15T01:59:34.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5145372

*Federal Register* notice: FDA has classified self-fitting air-conduction hearing aids into Class 2 (special controls). The classification was made based on a 5/2019 Bose Corp.-submitted *De Novo* classification request for the Bose Hearing Aid. FDA has identified such aids as a wearable sound amplifying device that is intended to compensate for impaired hearing and incorporates technology, including software, that allows users to program their hearing aids. This technology integrates user input with a self-fitting strategy and enables users to independently derive and customize their hearing aid fitting and settings. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2019-10-28/pdf/2019-23464.pdf?ref=fdaweb.com).