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# Use 510(k) for OTC Hearing Aids: Authors
- URL: https://www.fdaweb.com/use-510-k-for-otc-hearing-aids-authors/
- Published: 2020-11-25T12:00:00.000Z
- Updated: 2026-09-14T16:38:04.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5148170

Two Massachusetts Eye and Ear Hospital doctors say FDA should use the 510(k) pathway to clear over-the-counter hearing aids. Writing in a *Perspective* [column](https://www.nejm.org/doi/full/10.1056/NEJMp2027050?query=featured%5Fhome&ref=fdaweb.com) in the *New England Journal of Medicine*, the doctors say the agency has missed its legislatively-mandated deadline to release rules governing over-the-counter hearing aids for adults with perceived mild to moderate hearing impairment.

The article suggests that FDA build on the experience gained from its 10/2018 clearance of a Bose Corp. self-fitted air-conduction hearing aid through the *de novo* pathway. (The company has not yet commercialized the device in the U.S.) The authors say the indication for this unit is identical to that specified by Congress for OTC hearing aids.

To obtain FDA clearance, Bose conducted a pre-market clinical study with 75 people. The results, the article says, supported FDA clearance of the device and establishment of a new device type, which is now subject to premarketing review under the 510(k) pathway for moderate-risk devices.

“We believe FDA should build on this experience and require OTC hearing aids to be reviewed under the 510(k) pathway,” the authors write. “It may seem counterintuitive for FDA to regulate OTC hearing aids in this way while continuing to exempt prescription devices (some of which are indicated for the treatment of severe-to-profound impairment) from premarketing review. This level of regulatory control, however, could help assure the safety and effectiveness of OTC devices in the absence of traditional postmarketing clinical oversight.”