Two weeks ago, news came in from the Food and Drug Administration. It had created a new category for people with mild to moderate hearing loss. These adults will be able to buy hearing aids without a prescription from October.
It was a long time coming. In 2017, Congress passed a new FDA clearance that included the bipartisan OTC Hearing Aids Act. At the time, hearing aids required a prescription and cost between $5,000 and $10,000. Often, health insurance does not reimburse them; Medicare does not. Hearing is a big deal, and I think it should be affordable for everyone. The purpose of the over-the-counter hearing aids law was to reduce these costs.
But progress has been slow. Bose, the speaker company, released a new set for less than $1,000 in October 2018, but it took them another year to get approval to market them as hearing aids. Alas, after a year of sale, Bose leaves this company. This is the nature of competition.
To encourage more entry into this industry, the FDA’s latest announcement is a positive step, an important step. I hope this will promote competition and innovation in the hearing aid market. People seem to want more choice in health care, which puts their health in their own hands.
The National Institute on Deafness and Other Communication Disorders reports that “approximately 18.8 million American adults could benefit from the use of hearing aids.” Dementia research indicates that hearing loss in middle-aged people may be a contributing factor.
These new, cheaper hearing aids aren’t for everyone. Now that the FDA has released its final rule, Americans with mild to moderate (perceived) hearing loss will be able to purchase a hearing aid without a medical exam or prescription.
Minors, or those with severe hearing loss, will still need to have a prescription.
Many of us, myself included, haven’t had our hearing checked since elementary school. I remember the hearing test, wanting to do well, then forgetting about it. But time passes and this information may be useful one day.
Defining hearing loss is difficult, which is why the word “perceived” is sometimes used before the words “mild” and “moderate”. How is this perceived? Audibility range is a measurement. The normal limit (or mild hearing loss) is considered to be between 25 and 30 decibels, decibels being a unit to express the relative difference in power.
One problem that these new aids will have to overcome is the poor quality of other over-the-counter hearing aids that have been marketed by mail order. They had a 35% to 50% return rate. Apparently they don’t amplify effectively and could only handle borderline cases at best.
Some people may have no other options. It might be better to have the $5,000 hearing aid if money isn’t an issue, but for many it is, and a larger market will lead to further innovation. Adjustable Bluetooths are popular now. And the new computer chips inside can perform more calculations per minute than ever before, improving sound quality.
Compare that to the days of old when a hearing impaired person would put a hand behind their ear. This would provide 10 decibels of amplification, qualifying as a hearing amplifier.
Next are talking tubes, which consist of a tube (or pipe) used to speak from one person to another in public places. Next came ear trumpets, a horn-shaped instrument that could direct sound into the ear of a hearing impaired person. But they weren’t portable, and portability was what was needed. So researchers continued to refine and manufacturers continued to compete.
And so, through the ages, hearing aids have been refined by technological change and competition to restore the ability to listen to music or enjoy the conversation of family and friends. The FDA has taken an important step in making more changes to help us all.
— That’s the opinion of Barbara Banaian, a member of the Times Writers Group, a professional pianist who lives in the St. Cloud area. His column is published the first Sunday of the month.