- Published on 22 December 2016
Many organizations have reacted to the FDA’s recent decision on over-the-counter hearing aids, including the Academy of Doctors of Audiology, the Hearing Industries Association, and the American Speech-Language-Hearing Association.
The US Food and Drug Administration (FDA) recently announced that it will no longer enforce the requirement that people over 18 years of age receive a medical assessment or confirm a waiver before buying most hearing aids. The move is aimed at facilitating access to hearing devices for millions of Americans who are not currently equipped.
The Academy of Doctors of Audiology (ADA) said that it supports the bill with the proviso that the over-the-counter products “be very specifically labelled and include a strong recommendation that a patient seek a comprehensive audiological evaluation from an audiologist or physician.” The academy added that data appear to show the risk of non-treatment may be greater than the risk of self-treatment.
The Hearing Industries Association (HIA) indicated that it supports efforts to increase the accessibility and affordability of hearing aids but was concerned about self-diagnosis. “The Over-the-Counter Hearing Aid Act of 2016 would compel the Food and Drug Administration (FDA) to allow OTC hearing aids. This will require consumers to self-diagnose both the cause and degree of their hearing loss... It would do so in spite of the fact that no studies have indicated that people can accurately self-diagnose either the cause or the extent of their hearing loss.”
From the point of view of the American Speech-Language-Hearing Association (ASHA), consumers cannot and should not diagnose hearing loss themselves. The group believes that patients should be strongly advised to seek a comprehensive audiological evaluation before using any type of amplification device.Source: Bloomberg; American Speech-Language-Hearing Association; Hearing Industries Association