What is a Prescription for a Hearing Aid?

The Food and Drug Administration (FDA), as part of the Over the Counter (OTC) Hearing Aid Act provisions, created two, new classes of hearing aid.??One was the OTC class.??The other is known as the Prescription Class.??This class encompasses air conduction, bone conduction, self-fitting, wireless and legacy devices.?

The FDA defines the Prescription class as “a device that is: (1) either in the possession of a person, or his agents or employees, regularly and lawfully engaged in the manufacture, transportation, storage, or wholesale or retail distribution of such device or in the possession of a practitioner, such as physicians, dentists, and veterinarians, licensed by law to use or order the use of such device and (2) is to be sold only to or on the prescription or other order of such practitioner for use in the course of his professional practice”.?Per the FDA, the prescription class will “be sold only to or on the prescription or other order of a practitioner licensed by law to use or order the use of (prescribe) the devices”.?States may continue to regulate the hearing aids, that now fall within the prescription class, as they have for many years. The States will again determine the evaluation, prescription, return for credit, trial period and dispensing provisions of this class of device.?

So, what is a hearing aid prescription? Unlike prescription?eyeglasses, the Federal Trade Commission has yet to weigh in on the hearing aid prescription issue. Also, the FDA, specifically in comments 25, 120, 124, 126 and 127 of the?FDA Final Rule on Establishing Over the Counter Hearing Aids, declined to make that determination and it leaving up to States to define the prescription and dispensing of this class of device.?

Prescribing involves assessing the patient (i.e., testing), documenting test results, and creating a recommendation for, at a minimum, the style and features required to meet the patient’s audiometric and communicative needs. Dispensing is the sale and distribution of OTC or prescription hearing aids.???So, again, if we follow the optometry model, the individual who creates the prescription does not have to be the same individual who fulfills it.??The patient determine how they obtain their prescription devices once the prescription has been created.?

If we use our colleagues in?optometry?as guides, the “prescription” could take on similar, yet varying forms, in each US state and territory. Here are some considerations we each will need to consider as the question of “what is a hearing aid prescription?”:?

Who can “prescribe”??

• My opinion and some considerations:
• It should not be harder to get a hearing aid today than it has been for the last six decades.
• Prescribers for pediatric (birth to 17 years of age)
• Evaluated, in person, by a licensed audiologist or physician, who personally provided the procedure, and medically cleared by a physician, preferably an otolaryngologist.?
• Evaluations should have occurred within the previous six months.
• Devices can be dispensed by any licensed dispensing provider.?
• Prescribers for adults (18 years of age and older)
• Evaluated, either in person or via telehealth, by a licensed audiologist, hearing aid dispenser, or physician, who personally provided the procedure.
• Adults should not be able to waive a prescription unless replacing a lost or stolen hearing aid within a loss and damage warranty.?
• Completion of the?Consumer Ear Disease Risk Assessment?and referral for resulting medical clearance when warranted.??
• Medical clearance, when warranted and required, must occur within the past six months.?
• I want to editorialize here for a moment.??I hope we learned SOMETHING from the pandemic.??There are evidence-based ways to evaluate hearing and communication remotely and without face-to-face interactions. We need to be better able to meet consumers where they are and improve ACCESS to provider delivered care. These rules afford us the opportunity to re-evaluate our evaluation and care delivery models and determine what information is vital in creating a meaningful prescription. I hope that, as we explore these changes, that we do not make it harder to get hearing aids and, instead, make it easier to get prescription hearing aids.??Protectionism at all costs (and of what) isn’t the way to expand the market.?

What should a “prescription” require (at a minimum; providers may, individually, require testing that exceeds these minimum standards when medically necessary):?

• Name of patient.
• Issue date.?
• Expiration date (i.e., one year) of prescription.?
• Name and license number of prescribing provider.?
• Results of assessment:
• Hearing Handicap Inventory or similar standardized, evidence-based tool.
• Pure-tone air conduction audiometry.
• Bone conduction testing or?CEDRA?or similar standardized, evidence-based tool.
• Recorded speech in quiet.?
• Recorded speech/digits in noise.
• Type/style of device.
• Medical necessity of the recommended features.?
• Make, model and style (although, this can be shopped with other providers).?
• Again, to editorialize: An audiometric assessment needs a 21st?century reboot. The evaluation we used in the 1970s should be re-tooled given what we know about the ear/brain connection and the issues which plague hard of hearing consumers. We need to begin to embrace telehealth and evidence-based remote and self-assessment.?

So, these changes are going to happen with or without audiology involvement or engagement.??Dispensers in many states, supported by their manufacturing partners (GN Resound, via Beltone, just donated $100K to the International Hearing Society to fund advocacy) will try to expand their scope of practice into the practice of audiology without commensurate education. If you want a voice in the hearing aid prescription questions and if you want to fight potential scope creep, it is important that your ENGAGE at the State level, through State association membership, monetary donations, and volunteer activities and through membership in national associations who are taking up these issues. Every State hearing aid dispensing law will need to be addressed to account for these FDA regulatory changes. I, again, do not want to hear complaints, at the end of all of this, if you do not donate time and treasure to the state and national organizations who are doing the heavy lifting on this issue.??Lobbyists and legal counsel cost thousands of dollars each month/year and every state or national association does not have a manufacturer benefactor.??It is NOT someone else’s responsibility to fund and advocate for these issues and YOU! It’s YOURS!?