You call your favorite uncle to wish him a happy birthday and he says, “What? Speak loud! “You say it again, louder, and he says,“ Who is that? ”You spend the rest of your call screaming, making yourself heard, and wondering why he’s not getting a hearing aid, if he’s like many Americans the reason is simple: cost.

Hearing aids are prohibitively expensive for many people, especially those on a fixed income. Customers pay an average of $ 2,372 for a single hearing aid that is expected to last three years. Medicare does not cover any costs and neither does most private insurers.

That’s why Senators Elizabeth Warren, Chuck Grassley, Maggie Hassan, and Johnny Isakson introduced the Over-the-Counter Hearing Aid Act, which was signed into law in 2017 on a rare show of non-partisanship. This meant the FDA would be working towards regulating and approving over-the-counter hearing aids for the first time. Much like reading glasses, these hearing aids can be sold in drug and grocery stores at much lower prices than you would get if you ordered through an audiologist.

Delayed decision

The FDA had to publish its proposed regulations by Aug. 18, 2020, but reportedly did not report on changing priorities during the pandemic.

That is not acceptable to the senators who proposed this. In their November 13, 2020 letter to FDA Commissioner Stephen M. Hahn, Senators Warren and Grassley write, “The impact of the novel coronavirus on the agency’s priorities and workload cannot be overstated, and we applaud the continued efforts of the FDA to Respond This global crisis has hit so many Americans deeply. Despite the pandemic, hearing loss continues to be a problem for millions of Americans, and we believe the FDA must also make issuing OTC hearing aid regulations a priority that is lawful. We respectfully ask the agency to release the proposed rule immediately. “

The scope of the problem

When you cannot communicate well with others, you are more prone to feelings of isolation and depression. Both are already a big issue for seniors. Hearing loss affects quality of life and affects 1 in 3 people over 65 years of age and 2 in 3 people over 75 years of age.

Yet only 14 percent of the hearing impaired use hearing aids.

Change tech

Hearing aids have made great strides in recent years; Whisper uses artificial intelligence to adjust to different sound settings, for example, and modern hearing aids are now smaller and less noticeable than their older, feedback-buzzing counterparts. Many now use wireless technology to connect directly to phones, televisions, and other devices so that audio signals are sent directly to the hearing aid. Newer hearing aids often contain rechargeable batteries instead of relying on single-use batteries.

As for these devices online …

There are already devices marketed as OTC hearing aids, but all of them that call themselves and are against the law. These devices are not currently regulated and are known as Personal Sound Amplification Products (PSAPs). PSAPs are intended for people without hearing loss who only want to turn up the volume occasionally, e.g. B. Listen to TV without turning up the volume and annoying speakers around them. The FDA says people with hearing loss should always consult a professional.

But is there a catch with OTC devices?

Audiologist Rachel Raphael, MA, CCC-A, tells Medical Daily that there is a mix of good and bad here. “Yes, they will be a lot cheaper and get reinforcement in the ears of more people, but they won’t be perfect or come with the fitting, fitting, counseling and TLC that we audiologists offer. Our prices are high because we charge a “bundled” price (first class and latest hardware for hearing aid technology, bundled with assembly, adjustment, repair, replacement in the event of loss, troubleshooting, cleaning and delivery of spare parts such as domes, batteries, filters, etc.) over the life of the hearing aid). “

She says some donors are rethinking their pricing strategies and “unbundling” the price of hearing aids from the service package and office visits to compete with the lower prices that OTC can offer.

The take away

“Ultimately, the OTC devices will be beneficial for some people, but not for the more complex fitting cases and not for severe / profound hearing loss and unusually shaped ear canals – which custom hearing aids are better suited to,” says Raphael.

Despite the delay, OTC hearing aids are expected to be available in stores in 2021.

Jenna Glatzer is the author or ghostwriter of more than 30 books, including Celine Dion’s authorized biography.

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