The US Food and Drug Administration (FDA) has identified several Class II medical devices used in the hearing healthcare field that the Agency deems no longer necessary to require 510(k) premarket notification, including electronic noise generators in audiometry, master hearing aids, group auditory trainers, and middle earmolds. The specifics are published in the December 30, 2019 Federal Register.
The recently published notice applies to devices in 16 broad classes, and includes a range of anesthesiology, cardiovascular, dental, and ear, nose, and throat devices. The following Class II (special control) hearing-related devices are now exempt from the premarket notification procedures (see Federal Register for details):
- Auditory impedance testers and tympanometers (§ 874.1090);
- Electronic noise generator for audiometric testing (§ 874.1120);
- Hearing aid calibrator and analysis system (§ 874.3310);
- Group hearing aid or group auditory trainer (§ 874.3320);
- Master hearing aid (§ 874.3330);
- Middle ear mold (§ 874.3430);
- Electroglottograph (§ 874.1325), and
- Laryngeal prosthesis (Taub design) (§ 874.3730).
This latest deregulatory action is in response to the 21st Century Cures Act of 2016 which is designed to “help accelerate medical product development and bring new innovations and advances to patients who need them faster and more efficiently.” Part of the law mandates and provides funding for the FDA to identify low-risk devices that provide reasonable assurance of safety and effectiveness, and that should no longer require 510(k) review.
A 510(k) process is a pre-market submission made to FDA to demonstrate that a medical device is at least as safe and effective (ie, substantially equivalent) to other legally marketed devices not subject to premarket approval (PMA) or special regulatory requirements. Premarket notification and clearance can pose a hurdle for medical device manufacturers by increasing costs and/or delaying the product from entering the market. Class II medical devices (eg, wireless hearing aids and most hearing testing/diagnostic equipment) can be classified with general controls or special controls, and are deemed by FDA to have a moderate to high risk to the patient and/or user. Class I (eg, tongue depressors) and Class III (eg, pacemakers and cochlear implants) medical devices are deemed to have the lowest and highest risk factors to consumers, respectively.