How will the new FDA hearing aid regulations affect health plans? ,

How will the new FDA hearing aid regulations affect health plans?
Thomas Tedeschi — Head of Audiology, Amplifon Americas

Finally the time has come. The Food and Drug Administration’s new over-the-counter (OTC) hearing aid rules are now in effect and health plans are starting to figure out what it means for them. Among the many questions they may have to grapple with, some are particularly prominent:

– How will the new rules affect their benefit offerings?

– Will new opportunities arise?

– What potential pitfalls should they be aware of?

Introducing OTC Hearing Aids

First, let’s examine the new regulatory framework established by the FDA. For the first time ever, all hearing aids will fall into two categories: prescription hearing aids and OTC hearing aids.

Prescription hearing aids will require the consumer to obtain a prescription for the hearing aid from a physician, audiologist or licensed hearing instrument specialist.

– Other – Brand new – The category of hearing aids will be available over-the-counter without the involvement of a licensed hearing care professional for people 18 years of age and older. These OTC hearing aids do not require a prescription.

This OTC category further breaks down into two types of products: self-fitting OTC hearing aids with some preset settings that users can control via an app or volume control wheel; And the other type, which isn’t self-fitting – basically an amplifier with a volume control.

There are no OTC hearing aid products on the market yet because the rule does not go into effect until October 17, 2022. To feel like

The availability of OTC devices is expected to increase awareness of hearing care in general and encourage more consumers to address their hearing health needs. These are very important goals. About 40 million people have some degree of hearing loss, yet it is not widely diagnosed and treated. In fact, of the 35 million Americans who could benefit from hearing aids, only one-third use them.ยน

key decision

The new rules do not require health plans to offer OTC hearing aids to their members. It is up to each health plan to make this decision. Thus, it is extremely important to carefully evaluate the pros and cons.

In determining how to respond to the regulations, health plans must make several important decisions:

– Advantage DesignQ: If an OTC hearing benefit is offered, should it be a stand-alone OTC benefit or integrated with the prescription hearing aid benefit?

– Product safety and efficacy for members, How to verify medical need for OTC products for members โ€“ such as through in-person or virtual assessments โ€“ to improve quality of care?

– Delivery Model, Whether to ship OTC products to a hearing clinic where the consumer can receive professional diagnosis, fitting and support, or ship directly to the consumer’s home which provides convenience but no professional assistance (and increases the risk of fraud) ), or offer both options?

– testing, Are members required to complete a hearing test (in-clinic or virtual evaluation) to certify that the hearing loss is compatible with OTC solutions, or severe enough to require prescription hearing aids?

– after service, Does the clinic have to offer virtual support and/or alternative care packages purchased by members?

expanding membership

Regulations may provide health insurers with hearing loss an opportunity to attract new members and retain existing ones. The potential market is huge — an estimated 25.4 million US residents age 12 or older have mild hearing loss, and another 10.7 million have moderate hearing loss.2

For example, health plans may consider covering OTC hearing aids as part of a hearing benefits package offered to their Medicare Advantage plan members. Their message: Members can now receive an expanded hearing benefit that includes an OTC hearing aid for those who qualify for nominal or no out-of-pocket costs. Additionally, members who would prefer a prescription hearing aid may be covered for prescription devices, which would potentially involve an out-of-pocket expense.

educate members

Health plans that offer OTC benefits can take advantage of the opportunity to educate members about the important role they play in improving their overall health. Increased hearing can lead to many positive health outcomes such as improved cognitive ability, mental health and balance, and a more active social life.

Untreated hearing loss, on the other hand, is associated with social isolation and loneliness and can be a gateway to a number of co-morbidities, including dementia, depression and increased risk of falls due to injury.

All these comorbidities result in high health care cost. Individuals with untreated hearing loss incurred, on average, 46% higher total health care costs — $22,434 per patient — than their ‘normal’ hearing peers over the course of a decade, with health plans covering $20,403 of this amount, according to Johns Hopkins Medicine. Hopkins study. 3

Health plans may also combine extended hearing benefits with member education on how to use hearing aids and the importance of wearing them for at least eight hours per day. Under-utilisation is a significant problem โ€“ more than one-third of people with hearing aids wear them for less than eight hours a day.4 And compliance tends to decline over time.

potential hazards

– Danger, Health plans must be alert to potential harms arising from the new regulations. For example, in furtherance of the laudable goal of increasing access and affordability of hearing healthcare, the FDA does not require that a hearing health professional verify a member’s hearing loss to be eligible for an OTC device. This creates the potential for misuse of benefits by members receiving OTC assistance, even if they do not have hearing loss, to pass it on to a family member or friend in need.

– Vague coverage requirements, The rules limit the OTC hearing aid category to individuals with “perceived mild to moderate hearing loss.” But the rules do not define or explain the meaning of that term. Instead, they rely on consumers to determine whether the perceived level of hearing loss is mild or moderate based on the experience of general symptoms such as difficulty hearing over the phone. Basing diagnosis solely on the subjective assessment of consumers can be inaccurate and lead to potential problems.

For example, consider a member who thinks she has moderate hearing loss and receives an OTC hearing aid under her insurer’s benefit plan. However, her hearing loss is actually in the moderate to severe range, well beyond the capability of OTC aids. The device marginally improves his hearing, and even after a few months, he still has trouble, especially in restaurants and other noisy environments. So, she requests a prescription hearing aid that can greatly improve her hearing. This put the insurer in a difficult position, as it lost hearing benefits for the first year it received the OTC device.

– possibility of overamplification, The regulations reduce the overall maximum output limit in recognition of the need to make OTC hearing aids safer. Nevertheless, without clinical oversight by hearing care professionals, consumers may still be subject to an increased risk of overamplification of loud sounds by these devices. Instead of improving the consumer’s hearing health, the result may be additional hearing damage.

– Impact on member satisfaction. Member satisfaction is critical for health plans to remain competitive. For Medicare Advantage plans, a positive member experience is critical to receiving a 5-star rating. With the introduction of the new category of OTC hearing aids, there is a lack of clarity in coverage requirements and members exercise clinical oversight in selecting the most appropriate hearing aid on their own. Additionally, not all members can adjust the hearing aid settings themselves to meet their unique needs, which leads to frustration. Health plans can design listening benefits that minimize this potential issue while at the same time maximizing member satisfaction.

Hearing loss is the third oldest physical condition in America, yet remains largely untreated. By allowing retail sale of affordable hearing aids, FDA regulations go a long way in helping consumers address this challenge, yet may pose risks to health plans. For health plans, now is the time to carefully weigh the potential value of an OTC offering against the risks and concerns.


About Thomas Tedeschi

Thomas J. Tedeschi, Au.D. Chief Audiology Officer for Amplifon Hearing Health Care. Author of numerous articles in clinical and practice management publications, Dr. Tedeschi is primarily responsible for Amplifon’s government affairs. Amplifon partners with health care organizations to provide hearing benefits to its members.

sources say

  1. MarkeTrak 10: Hearing Aids and DTC/OTC Devices in the Age of Disruption, https://tinyurl.com/yyy64gaz
  2. Goman, Adele M, Am J Public Health 2016 Oct;106(10):1820-2. DOI: 10.2105/ajph.2016.303299. Epub 2016 Aug 23. Prevalence of hearing loss by severity in the United States
  3. Johns Hopkins Bloomberg School of Public Health (2018), “Patients with untreated hearing loss face higher health care costs over time,” news release (November 8), https://tinyurl.com/ychlw2yc
  4. Eurotrack UK 2018, Bihima

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