The hearing aid market is ripe for disruption due to the recent decision by the U.S. Food and Drug Administration to allow over-the-counter sales of hearing aids.
The FDA finally issued a final rule a week to expand access to OTC hearing aids for those deemed to have mild to moderate hearing impairment and for those 18 and older. By mid-October, the group can visit retail stores and pharmacies to purchase a pair of hearing aids without the need for a medical exam, prescription or visit to an audiologist.
The measure comes years after Congress passed bipartisan legislation in 2017 that pushed the FDA to create an OTC hearing aid category. The FDA’s move promises to reduce the high cost of hearing aids, but also marks an opportunity for entrepreneurs to improve a technology long dominated by a handful of manufacturers such as ReSound, Sonova and Demant. The global hearing aid market was valued at $10.1 billion last year, according to San Francisco-based market research and business consulting firm Grand View Research.
By setting new standards, big brands such as Franklin, director of the Cochlear Center for Hearing and Public Health at the Johns Hopkins Bloomberg School of Public Health, said Apple, Samsung and many others can now Convert their existing hearing devices into hearing aids. “This breath has opened up the market for a lot of innovation,” Lin said. “Once that happens, it automatically increases traffic, reduces costs significantly, and allows for a whole new world of innovation and competition in the field under previous conditions, which is not just an ageing issue, but a real Public health issues.”
A set of hearing aids ranges from $2,500 to $7,000 and lasts three to seven years. Most insurance companies, including Medicare, don’t cover hearing aids — let alone batteries, wax shields, and other accessories. Starkey, a hearing technology company based in Eden Prairie, Minnesota, says hearing aid batteries have an average battery life of 3 to 22 days. There are also rechargeable options.
But cost isn’t the only barrier to getting a set of hearing aids these days. Visiting is another issue, Lin explained, because patients seeking help have to work with an audiologist or otolaryngologist like him. Nonetheless, it may be in the consumer’s best interest to visit an audiologist for a fitting and be assessed by a professional to determine the degree of hearing loss. This can help consumers avoid purchasing hearing devices that may not be suitable for them.
FDA’s rule is seen as a huge win for consumers as millions of Americans suffer from hearing loss and many forgo treatment, according to Lin. Hearing loss isn’t limited to the elderly population — Johns Hopkins University estimates that about 14.3 percent of Americans age 12 and older, or about 38.2 million people, have hearing loss in both ears. According to an April 2019 report from the University of Iowa Carver School of Medicine, in the United States, there are 1.2 to 1.7 congenital hearing loss per 1,000 live births.
Not everyone is eligible for OTC hearing aids as the new rules apply to people with mild to moderate hearing loss. There are different hearing loss measurements that examine frequencies, ranging from mild and mild on one end of the spectrum to severe and severe on the other.
The company has seized this opportunity. Best Buy on August 17 announced a new experience for people with hearing loss, including an online hearing assessment tool and an expanded line of hearing devices. Best Buy, for example, will include products from Perth, Australia-based Nuheara, which hopes to enter the field with its smart earbuds to enhance hearing. Nuheara’s self-fitting hearing aids are currently awaiting FDA approval. Domestic companies are sure to follow suit.
Unlike a pair of glasses that can restore most people’s vision to a 20/20 baseline, hearing aids have not yet met that mark. Some users have reported that the hearing aids have not yet fully captured the timbre of the instrument, making the music sound more “flat”, like a recording.
Preventing hearing aids from getting wet is another obstacle. Some have higher protection ratings (IP ratings measure how well a hearing aid resists debris, water, and other substances), but there is still an opportunity to make hearing aids more resilient to these elements.
Lin points out that the innovation angle is particularly exciting because the market has historically been dominated by five manufacturers, and now smaller players can create out-of-the-box approaches because They deal with less restrictive markets.
“You now have a marketplace where companies produce products directly to consumers, which changes the volume of innovation and the product life cycle to respond quickly to consumer demand,” Lim said. “And now, it’s not like that.”
