510(k) Predicate Finder
Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.
Self-Fitting Air-Conduction Hearing Aid, Over The Counter
Ear, Nose, Throat
The Self-Fitting Air-Conduction Hearing Aid, Over The Counter is a wearable sound-amplifying hearing aid available without a prescription that incorporates self-fitting software technology enabling users to independently program, adjust, and customize their own hearing aid fitting and settings through user input combined with an automated self-fitting strategy. Available under the 2022 OTC Hearing Aid final rule (87 FR 50698), it empowers users to manage their hearing aid without audiological intervention. Classified as FDA Class 2 under regulation 874.3325, it requires 510(k) clearance in the Ear, Nose, and Throat specialty. It is not an implant and not life-sustaining.
510(k) Clearances
9 matchesWhat is a Predicate Device?
A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.
Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.
Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.