ASHA Welcomes Proposed FDA Regulations for Safety and Efficacy of Over-the-Counter Hearing Aids
Association Will Provide Comments to Agency to Help Ensure Public Health and Safety
October 19, 2021
(Rockville, MD) The American Speech-Language-Hearing Association (ASHA) is stressing the importance of a series of key provisions for appropriately ensuring public safety and device efficacy for over-the-counter (OTC) hearing aids as the U.S. Food and Drug Administration (FDA) will issue tomorrow for public comment the first proposed regulations for the devices.
“We thank FDA for its work on these important regulations, which will be essential for protecting the American public as a new class of medical devices is made available to them,” said A. Lynn Williams, PhD, CCC-SLP, 2021 ASHA President. “We will be closely analyzing the regulations in the coming weeks to provide substantive comments intended to support the effort to broaden access to hearing amplification technologies without sacrificing the health and safety of Americans—and also maximizing the efficacy of these devices.”
Hearing loss is a serious and complex medical condition that affects roughly 48 million Americans. It can have a significant impact on a person’s overall health, physical safety, and quality of life. People with hearing loss might have a higher risk of developing certain health conditions—including social isolation, depression, anxiety, falls and other injuries, and cognitive decline and dementia. As such, the need for appropriate diagnosis, care, and treatment of hearing loss is vital.
ASHA continues to maintain that the best approach to addressing hearing loss is to seek the professional services of an audiologist—a healthcare professional who provides patient-centered care in the prevention, identification, diagnosis, and evidence-based treatment of hearing, balance, and other auditory disorders for people of all ages. A recent national poll commissioned by ASHA indicated that the public is looking for professional guidance about OTCs.
Individuals cannot self-diagnose the cause or the magnitude of their hearing loss, nor will they benefit from the full scope of technological support, holistic hearing health care, and audiologic rehabilitation that many with hearing loss require from an OTC device alone. By side-stepping audiologist involvement in the fitting and screening of hearing aids, patients may grow frustrated managing the aids and may either adjust them incorrectly or stop wearing them. Patients could also further damage their hearing via over-amplification.
Consensus Paper Identifies Core Provisions for OTC Devices
In 2018, four organizations—ASHA, the Academy of Doctors of Audiology (ADA), the American Academy of Audiology (AAA), and the International Hearing Society (IHS)— developed and jointly endorsed a consensus paper to FDA outlining five evidence-based recommendations related to the safety and effectiveness of this new class of devices.
The consensus recommendations address (1) the product requirements appropriate for OTC hearing devices targeting mild-to-moderate hearing impairment; (2) outside-of-the-box labeling appropriate for medical devices sold over-the-counter; (3) comprehensive inside-the-box labeling; (4) naming the products “Self-Fit Over-the-Counter Hearing Devices,” adopting risk classifications consistent with air conduction hearing aids, and limiting 510(k) exemptions; and (5) establishing strong consumer protection laws.
ASHA maintains the need for the core provisions endorsed in the consensus paper—and will be joining its counterpart hearing health care organizations to consider how the proposed FDA regulations reflect these principles. Please send press inquiries to pr@asha.org.
About the American Speech-Language-Hearing Association (ASHA)
ASHA is the national professional, scientific, and credentialing association for 218,000 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 identify, assess, and treat speech and language problems, including swallowing disorders.
