Earlens Hybrid Impression Kit

Device typeEarmould impression kit: A collection of non-sterile supplies, instruments, and materials intended to be used to make an accurate impression of the folds and convolutions of cartilage that form the outer ear and its canal (i.e., an earmould). It typically includes a foam or cotton block, a mixing bowl, a spatula, impression liquid and/or powder; it also includes either a syringe or tube to deliver the impression material, or less frequently an impression tray for direct moulding. The mould of the ear is used to manufacture custom-made hearing devices such as hearing aids and earplugs. This is a single-use device.

FDA categoryKit, Earmold, Impression

Device ID00850013007349

Catalog numberHIK02

AvailabilityPrescription

MRI safetyLabeling does not contain MRI Safety Information