Position Reasserted in Wake of FDA Announcement.
Rockville, MD - December 9, 2016 - The American Speech-Language-Hearing Association (ASHA) today underscored the need for counseling and aural rehabilitation—provided by audiologists—to remain a critical part of public access to hearing aid technology.
ASHA emphasized the point as the U.S. Food and Drug Administration (FDA) announced this week that, starting immediately, it would no longer enforce the requirement that individuals over 18 years of age receive a medical evaluation or sign a waiver prior to purchasing most hearing aids. FDA continues to require medical evaluation for children prior to being fitted with a hearing aid.
ASHA believes that consumers cannot and should not diagnose their own hearing loss. Patients should be strongly advised to seek a comprehensive audiologic evaluation from an audiologist or physician prior to utilizing any type of amplification device or other treatment for hearing loss—especially if the patient exhibits any of the warning signs of ear disease (e.g., tinnitus, dizziness, drainage, sudden hearing loss, asymmetry, foreign body in the ear, cerumen impaction, and/or congenital or traumatic deformity of the ear). The purpose of an audiologic evaluation is to determine
- onset and time course of the hearing loss;
- degree, type, and configuration of the hearing loss;
- possible etiology of the hearing loss;
- functional limitations imposed by the loss, particularly with regard to communication; and
- need for additional medical or audiologic services, including the development of a treatment plan that may involve the fitting of hearing aids.
"Hearing loss is a chronic health condition that affects many body and brain systems and whose treatment requires consideration of the whole person," said ASHA 2016 President Jaynee A. Handelsman, PhD, CCC-A. "While ASHA strongly supports greater access to technology, a common misconception is that a hearing aid alone is enough to overcome a hearing disability. Treatment for hearing loss is more complex and requires a comprehensive assessment of a patient’s needs as well as professional counseling and aural rehabilitation provided by audiologists to ensure successful adaptation to hearing technology."
ASHA has previously requested in written comments and testimony to FDA that the agency take a more comprehensive look at hearing health care—including the audiologist’s role in addressing a hearing disability—rather than solely focusing on amplification devices. ASHA also urged FDA to make recommendations that consider evidence-based hearing health care practices to improve affordable access to audiology services in addition to devices.
ASHA has previously commented to FDA, in both a public presentation at the FDA and through formal comments, against changes to the current regulatory framework and stated that the FDA should take the following actions:
- Clarify and finalize guidance to make clear distinctions between personal sound amplification products (PSAPs), that are consumer electronic devices intended to amplify sound, and hearing devices, marketed for mild-to-moderate hearing loss, and strictly enforce compliance of hearing aid regulations.
- Require warning labels on PSAPs, devices, and aids regarding "red flags" for conditions that require medical treatment. Recommendations should also be included for individuals to seek the services of a hearing health care professional for their hearing health care needs.
- Work with the National Institute on Deafness and Other Communication Disorders, and other appropriate health research organizations, to develop pilot programs and/or demonstration projects to evaluate new delivery models. The data and findings from these studies should be made available to the public.
About the American Speech-Language-Hearing Association (ASHA)
ASHA is the national professional, scientific, and credentialing association for 186,000 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. www.asha.org
