Question
Is there a law that a patient must have a current audiogram within six months before being fit with a hearing aid? If not, how recently must the audiogram have been performed?
Answer
First, it should be noted that each state has its own requirements as to hearing aids, and generally these requirements vary and are subject to federal laws as well. Audiograms are generally not specifically mentioned, only appropriate evaluations, which would likely include audiograms as the standard of care.
As a general matter, the FDA has jurisdiction over the sale and manufacture of hearing aids as medical devices. It requires that dispensers must obtain a written statement from the patient signed by a licensed physician. It must be dated within the previous six months, state that the patient's ears have been medically evaluated, and state that the patient is cleared for fitting with a hearing aid. A patient can sign a waiver for a medical examination, but dispensers must advise the patient that waiving the examination is not in the patient's best health interest.
State laws vary as to requirements. For example, Virginia law indicates that "Any person engaging in the fitting and sale of hearing aids for a child under 18 years of age shall ascertain whether such child has been examined by an otolaryngologist or licensed physician within six months prior to fitting." Other states have a similar provision. However, Virginia is unusual in that it also specifies in detail the testing that is required. It notes, "It shall be the duty of each licensee ... engaged in the fitting and sale of hearing aids to use appropriate testing procedures for each hearing aid fitting. All tests and case history information must be retained in the records of the specialist. The established requirements shall be:
- Air Conduction Tests A.N.S.I. standard frequencies of 500-1000-2000-4000 Hertz. Intermediate frequencies shall be tested if the threshold difference between octaves exceeds 15dB. Appropriate masking must be used if the difference between the two ears is 40 dB or more at any one frequency.
- Bone Conduction Tests are to be made on every clientN.S.I. standards at 500-1000-2000-4000 Hertz. Proper masking is to be applied if the air conduction and bone conduction readings for the test ear at any one frequency differ by 15 dB or if lateralization occurs.
- Speech testings shall be made before fittings, and shall be recorded with type of test, method of presentation and the test results."
Compare New York State for its Medicaid beneficiaries:
"Hearing Aid Recommendation Requirements"
All recommendations for hearing aids for Medicaid-eligible patients must be in compliance with Article 37 of the NYS General Business Law.
The written recommendation must indicate that the recipient is in need of a hearing aid and include the results of pure tone and speech (clinical) audiometry conducted in a sound treated room and/or test suite meeting the American National Standard Institute's specifications. The otolaryngologist or qualified audiologist may either write a general recommendation for a hearing aid, or prescribe a specific device by indicating manufacturer and model required.
In support of a prescription for a specific hearing aid, sound field speech audiometry or equivalent testing methods must be performed. These tests must be conducted by or under the direction and personal supervision of an otolaryngologist or licensed audiologist. When a specific device is prescribed, the dealer must dispense as written.
When a general recommendation is made, the hearing aid dealer may perform hearing measurements by means of an audiometer or other testing equipment used solely for the purpose of selecting, fitting or dispensing an instrument designed to aid or improve human hearing. Hearing aids must be dispensed within six months of the date of the recommendation."
Hence, state law will dictate what is the appropriate requirement for audiograms as well as other tests for patients, as well as the time frame required, usually six months. However, in the absence of any express notation of audiograms, one must always meet the standard of care.
Bryan A. Liang, M.D., Ph.D., JD is Professor and Director of the Institute of Health Law Studies, California Western School of Law and University of California San Diego School of Medicine, San Diego, CA. His research focus is on the interface of law, health care, and public policy, including ethics, fraud and abuse, and patient safety.