The Academy of Doctors of Audiology (ADA) supports S.9, The Over-the-Counter Hearing Aid Act of 2016, and the ADA commends Senators Warren and Grassley for their foresight in introducing and advancing this legislation, which if enacted, will remove unnecessary and burdensome barriers to hearing care for millions of Americans.
The Over-the-Counter Hearing Aid Act of 2016 would allow hearing aids that are intended for use by adults to compensate for mild to moderate hearing impairment to be sold over the counter (OTC) and would eliminate the requirement that people obtain a medical evaluation or sign a waiver in order to acquire these hearing aids (note, since the bill’s introduction, the FDA issued guidance to remove the medical evaluation requirement). The Over-the-Counter Hearing Aid Act of 2016 also asks the FDA to issue regulations containing safety and labeling requirements for this new category of OTC hearing aids and update its draft guidance on Personal Sound Amplification Products (PSAPs).
The ADA and its members seek to foster expanded access for consumers to audiology services. We strive to accomplish this goal through the advancement of practitioner excellence and high ethical standards in the provision of quality audiologic care. The Over-the Counter Hearing Aid Act will help to facilitate these objectives and is consistent with the ADA’s mission and philosophy. View ADA’s June 29, 2016 comments to FDA, which contain these same recommendations.
ADA recommends that over-the-counter (OTC) products be very specifically labeled and include a strong recommendation that a patient seek a comprehensive audiologic evaluation from an audiologist or physician prior to purchasing any device for the treatment of hearing loss, especially if the patient exhibits any of the warning signs of ear disease (tinnitus, dizziness, drainage from the ear, sudden hearing loss, asymmetric hearing, foreign body in the ear, cerumen impaction, pain, congenital or traumatic deformity of the ear). The ADA also recommends labeling that states that the device is a “non- surgical, air conduction hearing aid intended to address mild to moderate hearing loss.”
With regard to amplification gain and output, appropriate safety measures should be undertaken for all amplification devices including hearing aids, smart phones, headphones, hearables, assistive listening devices, and PSAPs. The ADA strongly recommends that all amplification devices be required to adhere to defined maximum output thresholds.
The availability of OTC hearing devices, with the inclusion of appropriate labeling and safeguards, will allow consumers to make better informed decisions about their treatment options, and will likely also make products more affordable and accessible to the hearing impaired.
The Over-the-Counter Hearing Aid Act of 2016 implements recommendations from the President's Council of Advisors on Science and Technology (PCAST) and the National Academies of Sciences, Engineering, and Medicine (NASEM), which have both recommended making some type of hearing aids available over the counter and removing the requirement of a medical evaluation in order to allow millions more Americans to access hearing aids.
The ADA stipulates that there are risks with self-treatment, including overlooking conditions that warrant medical intervention. However, we contend that in the current regulatory environment, those risks are already being taken with either limited information--or worse yet, misinformation.
There is a preponderance of data available today which demonstrates that, when it comes to hearing loss, the risk of non-treatment may be greater than the risk of self-treatment. The prevalence of co-morbidities and maladies associated with hearing loss is well documented, as are the benefits of amplification in improving quality of life and mitigating serious health conditions. Therefore, the public will be best served if basic hearing devices are available to consumers over the counter, just as they are already available over the Internet and via mail order.
The regulatory environment has struggled to keep pace with rapid advances in hearing amplification technology. Creating an OTC hearing device market will foster competition, broaden consumer choice, improve affordability, and accelerate future innovation. Given that consumers already have direct-to-consumer Internet access to hearing aids and similar unregulated technologies, the creation of a regulated OTC class will not increase existing risks to the public.
In summary, the removal of the medical clearance requirement and the availability of a regulated OTC hearing device, which calls for FDA to include appropriate labeling and safety measures, will expand access to quality hearing health products and services, reduce duplicative costs, and remove unnecessary, non-beneficial barriers to care. For this reason, the ADA is pleased to support S.9, the Over-the-Counter Hearing Aid Act of 2016.
Read ADA’s June 29, 2016 comments to the FDA, which clearly articulate our alignment with Senator Grassley and Senator Warren on S.9, The Over-the-Counter Hearing Aid Act of 2016. We will keep ADA members informed about opportunities to contact your legislators in support of this bill during the 115th Congress if/when it is reintroduced.
ADA Supports S.9, the Over-the-Counter Hearing Aid Act of 2016
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