HAC Hearing Aid Compliance & Industry Regulations 3 — Questions and Answers
Question 1: Which organization publishes the Code of Ethics that most licensed hearing aid dispensers are expected to follow?
- American Academy of Audiology (AAA)
- International Hearing Society (IHS) (Correct answer)
- Better Hearing Institute (BHI)
- National Hearing Conservation Association (NHCA)
Correct answer: International Hearing Society (IHS)
The International Hearing Society publishes a Code of Ethics that guides the professional conduct of hearing instrument specialists.
Question 2: A patient returns a hearing aid 25 days after purchase and demands a refund. The state law requires a 30-day trial period. The dispenser must:
- Refuse the refund because it is past the manufacturer's 14-day policy
- Honor the refund per state law, which supersedes any shorter manufacturer policy (Correct answer)
- Offer store credit only
- Charge a restocking fee equal to 50% of the device cost
Correct answer: Honor the refund per state law, which supersedes any shorter manufacturer policy
State law sets the minimum trial period, and dispensers must comply with the longer state requirement regardless of manufacturer policies.
Question 3: Which of the following best describes 'informed consent' in hearing aid dispensing?
- The patient signs a standard form without explanation
- The provider explains all treatment options, risks, and costs so the patient can make a voluntary decision (Correct answer)
- Consent is assumed if the patient does not object
- Consent applies only to surgical procedures, not hearing aids
Correct answer: The provider explains all treatment options, risks, and costs so the patient can make a voluntary decision
Informed consent requires that the patient receive complete, understandable information about options, risks, benefits, and costs before agreeing to treatment.
Question 4: Under the Americans with Disabilities Act (ADA), a hearing care clinic must:
- Provide free hearing aids to patients who cannot afford them
- Ensure physical and communication accessibility for patients with disabilities (Correct answer)
- Employ at least one audiologist with sign language skills
- Waive all fees for patients with documented hearing loss
Correct answer: Ensure physical and communication accessibility for patients with disabilities
The ADA requires places of public accommodation, including medical offices, to be physically accessible and to provide effective communication for people with disabilities.
Question 5: A hearing instrument specialist sells a device that has not received FDA 510(k) clearance. This action constitutes:
- A minor administrative violation correctable by a fine
- Introducing an adulterated device into interstate commerce, a federal offense (Correct answer)
- A state licensing violation only
- Acceptable practice if the device is imported from a country with equivalent standards
Correct answer: Introducing an adulterated device into interstate commerce, a federal offense
Selling a Class II medical device without required FDA clearance is a federal violation under the FD&C Act, constituting introduction of an adulterated or misbranded device into commerce.
Question 6: When must a hearing aid dispenser provide a written contract or purchase agreement to the patient?
- Only for devices costing more than $1,000
- At or before the time of sale, in all transactions (Correct answer)
- Only when the patient requests it in writing
- Within 30 days after the fitting appointment
Correct answer: At or before the time of sale, in all transactions
Best practice and most state regulations require that a written purchase agreement be provided at or before the point of sale so patients understand all terms.
Question 7: Which federal law requires that veterans receive access to hearing health care and hearing aids through the VA system?
- Hearing Aid Tax Credit Act
- Veterans Benefits Improvement Act
- Consolidated Omnibus Budget Reconciliation Act (COBRA)
- Title 38 of the United States Code (Correct answer)
Correct answer: Title 38 of the United States Code
Title 38 U.S.C. governs veterans' benefits, including VA-provided audiological services and hearing aids for eligible veterans.
HAC Hearing Aid Compliance & Industry Regulations 3
Which organization publishes the Code of Ethics that most licensed hearing aid dispensers are expected to follow?