IHS Hearing Aid Dispensing Laws and Regulations — Questions and Answers
Question 1: Under FDA regulations, which of the following is required before dispensing a hearing aid to an adult patient?
- A prescription from a licensed audiologist
- A medical evaluation by a licensed physician or a signed waiver (Correct answer)
- Proof of health insurance coverage for the device
- A mandatory 90-day trial period for the instrument
Correct answer: A medical evaluation by a licensed physician or a signed waiver
FDA regulations require that adults receive a medical evaluation by a licensed physician within six months prior to purchasing a hearing aid, OR sign a written waiver indicating they are aware of this recommendation but choose to waive the medical examination. Adults (18+) may waive this; the waiver option does not apply to children under 18.
Question 2: According to FTC regulations, what is the MINIMUM trial period a hearing aid dispenser must offer to consumers?
- 15 days
- 30 days (Correct answer)
- 45 days
- 60 days
Correct answer: 30 days
The FTC's Cooling-Off Rule, as applied to hearing aid sales, and many state laws require a minimum 30-day trial (return) period. During this period, consumers may return the hearing aid for a refund, though dispensers may deduct a specified restocking or fitting fee.
Question 3: The FDA classifies hearing aids as which type of medical device?
- Class I (General Controls)
- Class II (Special Controls) (Correct answer)
- Class III (Premarket Approval)
- Class IV (Investigational)
Correct answer: Class II (Special Controls)
Hearing aids are FDA Class II medical devices, subject to Special Controls including performance standards and labeling requirements. They require 510(k) premarket notification (demonstrating substantial equivalence to a predicate device) but not the more stringent Premarket Approval (PMA) required for Class III devices.
Question 4: Which of the following statements about over-the-counter (OTC) hearing aids, established under the 2022 FDA rule, is CORRECT?
- OTC hearing aids are intended for people with moderate-to-severe hearing loss
- OTC hearing aids require a hearing test by a licensed professional before purchase
- OTC hearing aids are intended for adults with perceived mild-to-moderate hearing loss and can be purchased without a professional fitting (Correct answer)
- OTC hearing aids are classified as Class III devices requiring premarket approval
Correct answer: OTC hearing aids are intended for adults with perceived mild-to-moderate hearing loss and can be purchased without a professional fitting
The 2022 FDA OTC hearing aid rule created a new regulatory category allowing adults 18+ with perceived mild-to-moderate hearing loss to purchase hearing aids directly without a prescription, exam, or professional fitting. They are Class II devices. They are NOT intended for severe or profound loss, and they are not suitable for children.
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?
- The manufacturer's warranty card for the hearing aid
- A copy of the signed medical waiver or physician's clearance (Correct answer)
- The patient's insurance card
- The original purchase receipt from the device manufacturer
Correct answer: A copy of the signed medical waiver or physician's clearance
A signed medical waiver (or documentation of physician clearance) is a regulatory requirement under FDA rules and is the most legally critical document in the patient file. Without it, dispensing a hearing aid to an adult who did not receive a medical evaluation constitutes a violation of federal law.
Question 6: State licensure for hearing instrument specialists is regulated by:
- The FDA exclusively at the federal level
- The FTC in coordination with state agencies
- Individual state licensing boards, which vary by state (Correct answer)
- The International Hearing Society, which issues a universal national license
Correct answer: Individual state licensing boards, which vary by state
Hearing instrument specialist licensure is a state-regulated function. Each state has its own licensing board, requirements (education, exam, continuing education), and scope of practice rules. The IHS is a professional membership organization, not a licensing authority — the NBC-HIS credential is a voluntary board certification, not a government license.
