HAC Hearing Aid Compliance & Industry Regulations 2

Question 1

Under FDA regulations, hearing aids are classified as which type of medical device?

Accepted Answer

Class II (special controls)

Answer

Class I (general controls)

Answer

Class III (premarket approval)

Answer

Class IV (investigational)

Question 2

Which federal agency oversees the sale and distribution of hearing aids in the United States?

Accepted Answer

Food and Drug Administration (FDA)

Answer

Federal Trade Commission (FTC)

Answer

Consumer Product Safety Commission (CPSC)

Answer

Centers for Medicare & Medicaid Services (CMS)

Question 3

What is the primary purpose of the FDA's 2022 rule establishing an OTC hearing aid category?

Accepted Answer

To allow adults with mild-to-moderate hearing loss to purchase hearing aids without a professional exam

Answer

To eliminate prescription hearing aids entirely

Answer

To reduce the price of prescription hearing aids

Answer

To require audiologists to stock OTC devices

Question 4

A dispensing professional discovers a patient's hearing aid was manufactured without required FDA labeling. What is the correct course of action?

Accepted Answer

Report the issue to the FDA and do not dispense the device

Answer

Sell the device anyway if the patient signs a waiver

Answer

Add the missing labels before dispensing

Answer

Notify the state licensing board only

Question 5

Which of the following is a required element on a hearing aid's labeling under FDA regulations?

Accepted Answer

Conditions for which medical evaluation is recommended before purchase

Answer

The dispensing professional's license number

Answer

A statement that the device is intended only for adults over 21

Answer

A list of all audiologists who tested the device

Question 6

Under HIPAA, a hearing care professional may share a patient's audiogram with a referring physician without a separate authorization if:

Accepted Answer

The disclosure is for treatment purposes

Answer

The patient is a minor

Answer

The patient has signed a general consent form for office visits

Answer

The audiogram was performed more than 6 months ago

Question 7

What does the term 'misbranding' mean in the context of FDA hearing aid regulations?

Accepted Answer

A device whose labeling is false, misleading, or missing required information

Answer

Selling a hearing aid under a false brand name

Answer

Using an unapproved logo on the device casing

Answer

Advertising a device in a foreign language without translation