IHS Hearing Aid Dispensing Laws and Regulations

Question 1

Under FDA regulations, which of the following is required before dispensing a hearing aid to an adult patient?

Accepted Answer

A medical evaluation by a licensed physician or a signed waiver

Answer

A prescription from a licensed audiologist

Answer

Proof of health insurance coverage for the device

Answer

A mandatory 90-day trial period for the instrument

Question 2

According to FTC regulations, what is the MINIMUM trial period a hearing aid dispenser must offer to consumers?

Accepted Answer

30 days

Answer

15 days

Answer

45 days

Answer

60 days

Question 3

The FDA classifies hearing aids 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 4

Which of the following statements about over-the-counter (OTC) hearing aids, established under the 2022 FDA rule, is CORRECT?

Accepted Answer

OTC hearing aids are intended for adults with perceived mild-to-moderate hearing loss and can be purchased without a professional fitting

Answer

OTC hearing aids are intended for people with moderate-to-severe hearing loss

Answer

OTC hearing aids require a hearing test by a licensed professional before purchase

Answer

OTC hearing aids are classified as Class III devices requiring premarket approval

Question 5

A hearing instrument specialist is required to keep patient records for a minimum period under most state laws. Which record is MOST critical to retain in the patient file?

Accepted Answer

A copy of the signed medical waiver or physician's clearance

Answer

The manufacturer's warranty card for the hearing aid

Answer

The patient's insurance card

Answer

The original purchase receipt from the device manufacturer

Question 6

State licensure for hearing instrument specialists is regulated by:

Accepted Answer

Individual state licensing boards, which vary by state

Answer

The FDA exclusively at the federal level

Answer

The FTC in coordination with state agencies

Answer

The International Hearing Society, which issues a universal national license