Adding Audiology and Hearing Aid Dispensing: Legal and Licensing Basics
For many otolaryngology practices, adding audiology and hearing aid dispensing is a natural extension of care. Patients with hearing loss, tinnitus, or balance problems often need diagnostic testing, and some of them will need hearing aids. Keeping those services in-house can improve coordination and convenience. But the legal side of adding audiology to an ENT practice involves professional licensing, state hearing aid sales rules, federal device regulation, payer rules, and business structure decisions that deserve attention before the first booth is installed.
This article provides a general overview of the topics ENT practices commonly review. It is general education, and laws vary by state, so the details should be reviewed by an attorney licensed in your state.
Key takeaways
Audiologists and hearing aid dispensers are typically licensed by the state, and the licensing agency and requirements vary.
Hearing aid sales are subject to state consumer protection rules, which often include written contract, disclosure, and trial or return requirements.
The FDA created an over-the-counter hearing aid category in 2022, which changed the market but did not eliminate state rules for prescription hearing aids.
Traditional Medicare does not cover hearing aids, though it does cover certain diagnostic audiology testing under specific rules.
Practices can add audiology through employment, contracting, or a separate entity, and each approach raises different legal questions.
Legal and licensing basics for adding audiology to an ENT practice
Audiologist licensure
Audiologists are licensed by state agencies, and most states require a doctoral degree, supervised clinical experience, and a national examination. In Texas, audiologists are licensed through the Texas Department of Licensing and Regulation. Practices should confirm that each audiologist holds an active license in the state where services are provided.
Hearing aid dispensing licensure
Many states license hearing aid dispensing separately. Some allow licensed audiologists to dispense under their audiology license, while others require an additional dispensing credential. Many states also license hearing instrument specialists, sometimes called fitters and dispensers, who are not audiologists. Texas licenses hearing instrument fitters and dispensers through the same state agency.
Physician involvement
States differ on whether and how physicians may dispense hearing aids directly, and on the role of physician medical evaluation before a hearing aid sale. These rules interact with federal changes described below.
Supervision of support staff
Audiology assistants or technicians may be permitted to perform certain tasks under supervision, but scope and supervision rules vary by state.
Federal device rules and the OTC category
The FDA's 2022 rule
In August 2022, the FDA issued a final rule establishing a category of over-the-counter hearing aids for adults with perceived mild to moderate hearing loss, effective in October 2022. OTC devices can be sold directly to consumers without a medical exam, prescription, or fitting by a licensed professional.
Prescription hearing aids
Hearing aids that do not meet the OTC category remain prescription devices, and state dispensing rules continue to apply to them. The FDA rule also affected certain earlier federal conditions for sale and preempted some state requirements that conflicted with the OTC category.
What it means for ENT practices
Some patients now arrive with OTC devices or ask about them. Practices adding audiology often consider how they will handle OTC questions, fittings for devices purchased elsewhere, and patient education about when a medical evaluation is appropriate.
State hearing aid sales rules
Hearing aid sales are commonly regulated as consumer transactions. Depending on the state, rules may address:
Written sales agreements with specific required terms
Trial periods and return rights
Disclosure of fees, including any restocking or fitting fees
Advertising standards for hearing aid promotions
Record retention for hearing tests and sales
Because these requirements are detailed and state-specific, many practices have their sales documents and advertising reviewed by counsel familiar with local rules.
Payer and billing considerations
Medicare
Traditional Medicare excludes hearing aids and related fitting exams from coverage. It does cover certain diagnostic hearing and balance evaluations when coverage requirements are met, and Medicare rules on ordering and billing audiology services have changed in recent years, so billing staff should confirm current requirements. Some Medicare Advantage plans offer hearing benefits through their own networks.
Commercial plans and third-party hearing benefits
Some commercial plans include hearing aid benefits, often administered by third-party hearing benefit companies with their own contracts and pricing rules.
Federal fraud and abuse rules
Where federal healthcare program patients are involved, the Anti-Kickback Statute and related rules may affect relationships with referral sources and manufacturers. Hearing aid manufacturers sometimes offer volume incentives, equipment, or travel, and those arrangements are worth reviewing.
Operational compliance once audiology is running
Records and privacy
Audiology records, hearing tests, and hearing aid sales documents are part of the patient's health information and fall under HIPAA. Practices typically decide how audiology records integrate with the main medical record and how long sales records are retained under state rules.
Advertising hearing aids
Hearing aid promotions, such as free hearing screenings or limited-time offers, can be subject to state advertising rules and federal consumer protection standards. Claims about device performance should be accurate and supportable.
Choosing a structure
Employing audiologists in the practice
The simplest approach is to employ audiologists within the existing professional entity. Employment agreements typically address duties, supervision, schedule, restrictive covenants where permitted, and ownership of patient records.
Contracting with an independent audiology group
Some practices contract with an outside audiology group that provides services in the practice's space. Agreements should clarify who bills, who owns records, how space and equipment are handled, and how the arrangement fits state and federal rules.
Forming a separate hearing aid entity
Some practices form a separate company for hearing aid sales. This can separate retail operations from medical practice, but it creates additional licensing, contracting, and compliance steps. Our article on business structure for ENT practices covers entity options more broadly.
Partnership implications
In a group, partners may differ on investing in audiology. Governing documents often address new service lines and how they affect ownership. See our guide on partnership lawyers for ENT practices. Audiology and hearing aid revenue is also an area buyers review, as discussed in our article on ENT private equity.
Questions to ask an attorney licensed in your state
What licenses do our audiologists and dispensers need, and who issues them?
What hearing aid sales disclosures, contracts, and trial periods apply in our state?
Should audiology be part of our current entity or a separate company?
How should agreements with manufacturers and hearing benefit companies be reviewed?
What should our audiologist employment agreements include?
Frequently asked questions
Do audiologists need a separate license to dispense hearing aids?
It depends on the state. Some states allow audiologists to dispense under their audiology license, while others require an additional credential.
Did the FDA OTC rule eliminate state hearing aid laws?
No. The 2022 rule created an over-the-counter category and preempted some conflicting state requirements, but state rules still apply to prescription hearing aid dispensing and professional licensing.
Does Medicare cover hearing aids?
Traditional Medicare does not cover hearing aids. Some Medicare Advantage plans offer hearing benefits.
Can an ENT practice employ audiologists?
In many states, yes. Employment terms, supervision, and licensing should be reviewed for the state where services are provided.
Should hearing aid sales be in a separate entity?
Some practices choose a separate entity and others keep sales in the medical practice. The choice depends on state law, operations, and ownership goals.
Request an introduction
Request an introduction to an independent business attorney who works with ENT practices. Learn more about business and legal planning for ENT practices. Call or text (972) 616-4581, or contact us. The form goes to [email protected].
This article is general information, not legal advice. PPP is an introduction service and is not a law firm. Please read our disclaimer.
If you are weighing a sale instead, see the five signs it's time to sell your ENT practice.
