ASHA Welcomes Final FDA Regulations for OTC Hearing Aids

(Rockville, MD) With the U.S. Food and Drug Administration’s (FDA) final rule for over-the-counter (OTC) hearing aids now available, the American Speech-Language-Hearing Association (ASHA) is praising the agency for the landmark regulations intended to ensure the safety and effectiveness of this new class of direct-to-consumer medical devices. 

“ASHA fully supports the creation of this new category of over-the-counter hearing devices, which will increase the availability and affordability of hearing aids for many Americans,” said Janice R. Trent, AuD, CCC-A, Vice President for Audiology Practice for ASHA’s Board of Directors. “It is important the public understands these devices are only for adults with perceived mild to moderate hearing loss, and to strongly consider getting a hearing assessment by a certified audiologist as a first step before they purchase anything.”

Hearing loss is a serious and complex medical condition that can affect a person’s overall health, physical safety, and quality of life. ASHA stresses that—although many people will be helped by OTC hearing aids—for others, a device alone will not be the most effective solution. Audiologists—trained health care professionals who provide patient-centered care in the prevention, identification, diagnosis, and treatment of hearing, balance, and other auditory disorders—will continue to be crucial partners for consumers as they seek help with their hearing issues, which can vary considerately—and, therefore, require various forms of care.

ASHA Comments, Concerns

ASHA submitted comments [PDF] to the agency on its draft regulations for OTC hearing aids in January 2022. The Association emphasized the need for safety—and strongly recommended that consumers obtain a hearing assessment before purchasing an OTC hearing aid. Such assessments are generally covered by insurance, even if follow-up treatment and/or hearing aids are not. Many people underestimate the severity of their hearing loss. Additionally, an assessment can help rule out other medical issues that may be causing a person’s hearing loss, ranging from earwax buildup to a tumor.

ASHA is still in the process of carefully reviewing the FDA’s final rule—which will take some time. Upon initial review, ASHA remains pleased with the majority of the included provisions. The output limit has been lowered to 111 dB SPL, or 117 dB SPL if the device is equipped with activated input-controlled compression, and devices are required to have a user-adjustable volume control. Additionally, device insertion depth has been more clearly defined (the device must remain 10 mm or greater from the tympanic membrane), and the language used in the warnings and other important information that shall appear outside and inside the packaging has been simplified.

ASHA’s comments also urged the FDA to clarify the effect of the rule on state laws requiring audiological evaluations. In response, the agency confirmed that the final rule does not preempt state laws requiring an audiological evaluation for minors, nor does it preempt other previously granted state exemptions applicable to non-OTC hearing aids.

However, ASHA does remain concerned that the final regulations do not contain a gain limit and that there is little to no mention of the benefit of seeking consultation from an audiologist prior to the purchase of any hearing aid.

ASHA Educational Resources

To help inform and protect consumers, ASHA has created a new Over-the-Counter Hearing Aid Toolkit. It is mainly intended for audiologists, primary care physicians, and pharmacists—to provide to their patients and customers. These professionals likely will be fielding the most questions on OTC hearing aids from people concerned with their hearing. The toolkit includes resources such as FAQs, hearing checklists, and more. Additionally, ASHA is forging partnerships with allied professional groups to educate the public.

Note to Reporters: For questions about ASHA’s position on OTC hearing aids, or to schedule an interview with an audiology expert, please contact ASHA Public Relations at pr@asha.org.

About the American Speech-Language-Hearing Association (ASHA)
ASHA is the national professional, scientific, and credentialing association for 223,000 members and affiliates who are audiologists; speech-language pathologists; speech, language, and hearing scientists; audiology and speech-language pathology support personnel; and students. Audiologists specialize in preventing and assessing hearing and balance disorders as well as providing audiologic treatment, including hearing aids. Speech-language pathologists (SLPs) identify, assess, and treat speech, language, and swallowing disorders.