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# De Novo Clearance of Bose Hearing Aid
- URL: https://www.fdaweb.com/de-novo-clearance-of-bose-hearing-aid/
- Published: 2018-10-05T12:00:00.000Z
- Updated: 2026-09-15T00:36:15.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5142526

FDA has allowed the de novo marketing of Bose Corp.’s Bose Hearing Aid, the first hearing aid that enables users to fit, program and control the device without assistance from a health care provider. The device is intended to amplify sounds for individuals 18 years or older with perceived mild to moderate hearing impairment.

The wireless air conduction hearing aid works by capturing sound vibrations through one or more microphones, according to an [agency release](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm622692.htm?ref=fdaweb.com). The signal is processed, amplified, and played back through an earphone placed in the ear canal. Patients can adjust the hearing aid through a mobile application on their phone.

  
“While users may fit, program and control the Bose Hearing Aid on their own, the device must comply with applicable federal and state laws regarding the sale of hearing aids, including state laws that might require hearing aids to be purchased from or dispensed by a licensed hearing aid dispenser,” FDA says. The agency is drafting proposed regulations for a new category of over-the-counter hearing aids as required by the FDA Reauthorization Act of 2017.