Page 10 - Healthcare News July/August 2022

EYE & EAR CONT’D
of the regulations and will soon summa- rize the guidance and potential practice implications for members. “However, upon initial review, ASHA is pleased with many of the included provisions,” it noted.
For example, ASHA noted that the out- put limit has been lowered, and devices are required to have a user-adjustable volume control. Additionally, device insertion depth has been more clearly defined (the device must remain 10 mm or greater from the tympanic membrane), and the language used in the warnings and other important
information appearing outside and inside the packaging has been simplified. “ASHA appreciates the FDA clarifying, and agree- ing with, our interpretation that the rule does not pre-empt state laws requiring an audiological evaluation for minors.”
In its submitted comments to the FDA last fall, ASHA emphasized the importance of an audiological assessment prior to the fitting of any type of hearing aid and urged the FDA to consider several revisions that would more clearly define and strengthen product requirements to ensure consumer
safety and device efficacy.
“ASHA is concerned that ... there is little
to no mention of the benefit of seeking consultation from an audiologist prior
to purchasing a hearing aid or if the user does not experience expected benefit from the device,” the association noted after the final rule was released. “ASHA is building partnerships with allied professional groups to educate the public on the benefits of consulting with an audiologist.”
ASHA encourages audiologists to begin utilizing the resources in its OTC Hearing
Aid Toolkit (www.asha.org/aud/otc-hear- ing-aid-toolkit) to prepare to incorporate these devices and the individuals utilizing them into their service-delivery model, adding that “there are also resources to educate the public on the importance of safe and efficacious hearing-loss treatment and appropriate use of OTC hearing aids, promote the value of audiology services, and collaborate with other healthcare pro- fessionals to ensure that we are supporting best practice, overall health, physical safety, and quality of life for those that we serve.” The Hearing Loss Assoc. of America (HLAA) struck a similar balance between enthusiasm and caution.
“We are hopeful that over-the-counter options will inspire some to take a first step to treat their hearing loss sooner. Ultimately this can mean a better quality of life, and avoiding the increased risk of de- mentia, falls, and isolation associated with untreated hearing loss,” HLAA Executive
“Establishing this new regulatory category will allow people with perceived mild to moderate hearing loss to have convenient access to an array of safe, effective, and affordable hearing aids from their neighborhood store or online.”
Director Barbara Kelley said.
She expressed relief that the new over-
the-counter class of hearing aids will be significantly less expensive than those currently on the market, and possibly help patients get past cost and stigma as barriers to care. But she still recommended seeing a specialist.
“This is an exciting step, but it’s still important to remember there’s no one-size- fits-all approach to hearing loss,” Kelley said. “For many, a hearing-care profes- sional will still be a part of an effective treatment plan. But opening more options is a big step in the right direction, for a growing problem that affects one in seven Americans.” v
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