Medical devices; ear, nose, and throat devices; classification of the wireless air-conduction hearing aid. Final rule

When we hear a sound, our nervous system is detecting sound waves—pressure waves of mechanical energy traveling through a medium. The frequency of the wave is perceived as pitch, while the amplitude is perceived as loudness.

The cochlea is a coiled structure in the inner ear that contains hair cells—the sensory receptors of the auditory system. Sound waves are transmitted to the cochlea by small bones attached to the eardrum called the ossicles, which vibrate the oval window that leads to the inner ear. This causes fluid in the chambers of the cochlea to move, vibrating the basilar membrane.

Auditory sensation, commonly called hearing, involves the transformation of sonic waves into neural impulses facilitated by the structures of the auditory organ. The prominent, flesh-like structure on the side of the head, called the auricle, directs sound waves towards the auditory canal. The auricle is often mislabeled as the pinna, a term more aligned with mobile structures like a feline's external ear. The auditory canal penetrates the cranium via the external auditory meatus of the...

Assessing tympanic membrane temperature involves using a tympanic membrane thermometer (TMT). Here is a step-by-step guide:
Step 1: Begin by practicing good hand hygiene to prevent the transmission of microorganisms.
Step 2: Turn on the thermometer and wait until the ready sign appears on the screen to ensure accurate measurement.
Step 3: Slide the probe cover in place to prevent cross-contamination.
Step 4: Instruct the patient to tilt their head to the side for comfort and check for cerumen...