Cutting Through the OTC Myths Let’s clarify ASHA’s involvement regarding over-the-counter hearing aids. Policy Analysis
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Policy Analysis  |   October 01, 2017
Cutting Through the OTC Myths
Author Notes
  • Neil DiSarno, PhD, CCC-A, is ASHA chief staff officer for audiology. ndisarno@asha.org
    Neil DiSarno, PhD, CCC-A, is ASHA chief staff officer for audiology. ndisarno@asha.org×
Article Information
Regulatory, Legislative & Advocacy / Policy Analysis
Policy Analysis   |   October 01, 2017
Cutting Through the OTC Myths
The ASHA Leader, October 2017, Vol. 22, 26-27. doi:10.1044/leader.PA2.22102017.26
The ASHA Leader, October 2017, Vol. 22, 26-27. doi:10.1044/leader.PA2.22102017.26
A turbulent health care policy landscape, coupled with the internet’s rapid spread of information, can lead to quick blurring of fact and fiction.
Conversations in the audiology community reveal some confusion about ASHA’s position on over-the-counter (OTC) hearing aids. ASHA would like to set the record straight on the association’s support of audiologists during this time of change. Here is a recounting of what some may think happened—and what actually happened.
Myth: ASHA advocated for the passage of the recent OTC hearing aid bill.
Fact: On Aug. 3, Congress passed H.R. 2430, the Food and Drug Administration (FDA) Reauthorization Act of 2017, which President Trump signed into law. Included in this legislation was the Over-the-Counter Hearing Aid Act of 2017, which mandates the FDA to develop regulations (within the next three years) for the purchase of OTC hearing aids by adults with perceived mild to moderate hearing loss.
When plans for this bill were first announced, ASHA took a position of total opposition to the bill. ASHA is the only professional audiology association to oppose the sale of OTC hearing aids. (ASHA maintains that self-evaluation, self-monitoring and self-treatment of hearing loss will not result in positive outcomes.) However, after declaring this position, ASHA was no longer invited to any stakeholders’ meetings related to the OTC hearing aid legislation.
If ASHA was shut out of the conversation completely, how could we hope to have any input into the regulations governing the sale of OTC hearing aids? ASHA decided to take a position that would at least allow us a seat at the table.
ASHA’s modified position states that the association could support the sale of OTC hearing aids for mild hearing loss only. This adjustment allowed ASHA to again be a voice in the conversation. Even though, ultimately, the legislation designates OTC hearing aids for both mild and moderate hearing loss, ASHA at least had the chance to advocate that moderate hearing loss not be included.

ASHA has been vocal about concerns regarding the retail sale of OTC devices.

Myth: ASHA supports OTC hearing aids.
Fact: In addition to expressing initial opposition to the Over-the-Counter Hearing Aid Act of 2017, ASHA has been vocal about concerns regarding the retail sale of these devices. Although it is true that some with mild hearing loss may benefit from OTC devices, ASHA’s position is to encourage anyone with greater than a mild degree of hearing loss to seek treatment by a certified, licensed audiologist. ASHA is concerned that people are not able to determine the degree or seriousness of their own hearing loss without professional services.
Also, while the legislation requires OTC products to have warning labels regarding use by children, ASHA remains concerned about the lack of any meaningful safeguards to ensure that these devices are not purchased or used by those younger than 18.
As Jeffrey Regan, ASHA’s director of government relations and public policy, wrote in a recent ASHA Leader blog post, “ASHA also maintains that hearing loss is a medical condition, and that by side-stepping audiologist involvement in the fitting and screening of hearing aids, patients may grow frustrated managing the aids and either adjust them incorrectly or stop wearing them. Patients could possibly also further damage their hearing via over-amplification.”.

It is ASHA’s belief that individuals with perceived hearing loss should seek the services of an audiologist.

Myth: ASHA sees the audiologist as no longer relevant to health care.
Fact: ASHA believes that patients with hearing loss will always need the services of an audiologist. Devices alone do not always meet the rehabilitative needs of people with impaired hearing. Successfully meeting a patient’s communication needs requires an ongoing partnership between the patient and their audiologist. Consumers with OTC hearing devices will need help to address the complexity of their hearing loss and achieve desired outcomes with their devices.
One silver lining to the OTC hearing aid bill is the increased media attention on the prevalence of hearing loss. The legislation is far from ideal, but many more people are aware of the audiology profession, the services we can provide and the growing number of people who will need to seek these services.
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October 2017
Volume 22, Issue 10