Final answer:
The FDA would not require a medical clearance if the patient was informed about the necessity of such clearance but signed a waiver opting out of it.
Step-by-step explanation:
The FDA would not require the patient/client to have a medical clearance in a few specific circumstances. According to the options given, the correct answer would be option B: if the patient was informed about the medical clearance, but signed the waiver. When a medical device like a hearing system is FDA-cleared, it means that the device is considered substantially equivalent to other devices already on the market. However, medical clearance may still initially be required unless indicated otherwise, such as in the case of a waiver being signed.
In contrast, FDA-approved devices are those that are new or substantially different from existing ones and must demonstrate safety and efficacy. If a patient has been fit for a replacement aid or ear mold within the last six months, typically the requirement for new medical clearance may be waived, potentially aligning with option C, depending on specific FDA guidelines and regulations at the time of fitting.