Question

The FDA would require you to do the following:

A. have both the medical clearance and waiver for each patient/client
B. have both the sound booth and the audiometer calibrated annually by the manufacturer
C. have your degree in audiology
D none of the above

Answer 1

The FDA's requirements for medical devices include ensuring safety and effectiveness, which involves regular calibration of devices like audiometers and sound booths, but not necessarily by the manufacturer.

Step-by-step explanation:

The FDA (Food and Drug Administration) regulates various aspects of healthcare, including the use of medical devices. While medical clearance and a waiver might be necessary for certain healthcare services, this is not specifically mandated by the FDA for each patient or client. What the FDA requires is that medical devices, such as sound booths and audiometers, are safe and effective for their intended use. This involves annual calibration of devices to ensure they are operating correctly, but it does not have to be specifically by the manufacturer. As for having a degree in audiology, this would be a requirement of state licensing boards or employers rather than the FDA itself.

Regarding exposure to noise levels, it is true that numerous government agencies and health-related professional associations caution against exceeding 85 dB for 8-hour daily exposures in the absence of hearing protection. However, this again is a recommendation rather than an FDA regulation. It is important to differentiate between FDA-cleared and FDA-approved devices, where clearance indicates a device is "substantially equivalent" to one already on the market, while approval requires demonstration of safety and effectiveness for new or significantly different devices.