Academy Responds to FDA Questions About Hearing Health Care
On June 30, the Academy filed extensive written comments with the Food and Drug Administration in response to questions raised about hearing healthcare by the agency as part of its Public Workshop on Good Manufacturing Processes for Hearing Aids, held April 21, 2016. Incoming Academy President Ian Windmill, PhD, was a presenter at the day-long workshop, which included representatives from the consumer, provider, and business communities. All were asked to answer questions related to the accessibility and affordability of hearing healthcare for adults whose genesis was the controversial report from the President’s Council of Advisors on Science and Technology (PCAST) related to hearing technology (October 26, 2015).
In providing the context for the Academy’s answers, Dr. Windmill made clear that treatment for hearing loss involves more than a device. Hearing care includes assessment and diagnosis of hearing loss, determination of the etiology of the loss and the impact on communicative function, and the development of a comprehensive treatment plan that may or may not include an amplification device.
- Can consumers self-diagnose, self-treat, and self-monitor mild-to-moderate age-related hearing loss? The Academy believes that patients can self-identify hearing loss, which is the ability to determine a deviation from normal function. Patients do not, however, have the tools, knowledge or clinical decision-making skills to self-diagnose mild-to-moderate or age-related hearing loss. Diagnosis can only occur following a thorough and comprehensive audiologic evaluation. Patients may be able to self-monitor their hearing status, auditory system function, or symptoms for changes over time, but they cannot self-treat their condition.
- What are the advantages and disadvantages of designating a distinct category of hearing aids as an over-the counter? A different class of hearing aids available to patients on an over-the-counter basis was recommended in the PCAST report, which inaccurately refers to hearing aids as consumer electronic devices. The Academy believes that hearing aids and PSAPs are two distinctly different categories of amplification devices. Hearing aids are medical devices regulated by the FDA to ensure patient safety. PSAPs are unregulated consumer electronic devices. The creation of a class of hearing aids that is unregulated would create confusion for the consumer and within the audiology community. Hearing aids and PSAPs should be the only two classes of amplification devices. Any over-the-counter device used to manage hearing loss should not be labeled as a hearing aid, but rather as a PSAP.
Further, should PSAPs be made available to administer mild-to-moderate age-related hearing loss, the Academy supports the following labeling: (a) an audiologic evaluation is recommended prior to purchasing any device to be used to manage hearing loss; (b) an audiologist or physician should be consulted if any of the red flag warning signs are present; (c) the best outcomes are achieved when devices are coupled with a comprehensive treatment plan; (d) the devices are not intended to be used by individuals with more than mild hearing loss; and, (e) the devices are not intended for use by anyone under the age of 21 unless recommended by a professional.
- What would be the implications of a broad availability of OTC hearing aids for patients other than those with age-related mild-to-moderate hearing loss? The Academy believes that the inability to diagnose forms or degrees of hearing loss will result in the use of OTC devices by persons other than those intended. For example, individuals with conductive hearing losses or more severe forms of hearing loss, those with atypical audiometric configurations, and individuals who are young to middle-aged adults will try these devices. There are safety risks from over or under amplification in the use of OTC devices, and these devices could have adverse effects on long-term outcomes. The use of OTC devices by children is more problematic than for adults. While the likelihood that parents will choose an OTC device for managing hearing loss in children may be low, the potential for abuse is present. There may be circumstances where OTC devices might be the best option for a child. However, that decision should be made by a professional.
Also, the Academy strongly recommended that the FDA eliminate the requirement for a medical evaluation (and waiver) before purchase of a hearing aid and replace it with a requirement for a comprehensive audiologic evaluation. There is no evidence that the medical evaluation provides a meaningful benefit, and most patients waive the requirement.
There has been an intense focus on the issues related to the accessibility and affordability of hearing health care for adults over the past year. These problems have been considered and debated by the FDA, the PCAST and the National Academy of Sciences, Engineering and Medicine, Committee on Accessible and Affordable Hearing Care.
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