In the wake of a recent announcement made by the US Food and Drug Administration (FDA), which stipulates that the organization is repealing the previously required physician evaluation or waiver in advance of hearing aid purchases by adults, the American Speech-Language-Hearing Association (ASHA) has issued a response. In its announcement, ASHA asserts that it is imperative for counseling and aural rehabilitation—provided by audiologists—to remain a critical part of public access to hearing aids.

ASHA emphasized this point as the 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. The 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 audiology 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 (eg, tinnitus, dizziness, drainage, sudden hearing loss, asymmetry, foreign body in the ear, cerumen impaction, and/or congenital or traumatic deformity of the ear).

According to ASHA, the purpose of an audiology 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 regards to communication; and
  • need for additional medical or audiological 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. Handlesman, 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 takes a more comprehensive look at hearing healthcare—including the audiologist’s role in addressing a hearing loss—rather than solely focusing on amplification devices. ASHA also urged FDA to make recommendations that consider evidence-based hearing healthcare practices to improve affordable access to audiology services in addition to devices.

ASHA has previously commented to FDA, in a public presentation at the FDA and through formal comments, against changes to the current regulatory framework and stated that the FDA should:

  1. 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. ASHA believes the FDA should strictly enforce compliance of hearing aid regulations.
  1. 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 healthcare professional for their hearing care needs.
  1. Work with the National Institute on Deafness and Other Communication Disorders (NIDCD), 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.

The American Speech-Language-Hearing Association (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 audiology treatment, including hearing aids. Speech-language pathologists identify, assess, and treat speech and language problems, including swallowing disorders.

Additional details about the FDA’s recent announcement regarding access to hearing aids can be found in a December 7, 2016 Hearing Review online article.

Source: ASHA