Over-the-Counter Hearing Aids Are Now Available

Hearing loss is a critical public health issue. Nearly 30 million adults in the US have some degree of hearing loss. Untreated hearing loss increases the risk of social isolation and depression and is one of the greatest modifiable risk factors for dementia. Although use of hearing aids has increased in the past several years, studies have found that in people over the age of 70 years, only about 18% who owned hearing aids used them. 1,2

In the past, the only hearing devices available in stores were known as Personal Sound Amplification Products (PSAPs), which are not alternatives to hearing aids. These devices are made for people without any hearing impairment to amplify sounds in certain situations, such as for recreational activities like bird watching or hunting. These are regulated as consumer electronics and not medical devices and may be more variable in terms of quality.7

The price of hearing aids has been a major obstacle for people. Traditional Medicare does not cover prescription hearing aids, which can cost between $4,000 and $5,000. Medicare Advantage plans typically include some coverage, but people still pay roughly 79% out of pocket. 1 There is a large potential market for over the counter (OTC) hearing aids. Roughly 90% of adults with hearing loss can be helped by OTC hearing aids, but sales have been restricted to licensed audiologists and other specialists, which has continued to keep prices high. Effective October 17th, 2022, consumers can buy OTC hearing aids in stores and online.1

On August 16th, 2022, the FDA issued their final rule to establish a regulatory category for OTC hearing aids to improve access and lower prices for millions of Americans.  The goal of the final rule is to foster innovation and competition in the hearing aid technology marketplace. Many manufacturers and retailers have not said much about new products, prices, or distribution yet, but some details have surfaced. Best Buy plans to open hearing centers in more than 300 stores in the 4th Quarter and has already added an online hearing assessment tool. Customers will be able to use this tool to assess their hearing and choose from nine brands; sales staff who have received specialized training will be able to provide assistance. Prices are said to range from $200 to $3,000, depending on varying functions. Sony also announced a partnership with WS Audiology Denmark, but specifics regarding their products have not been released. Bose Corp. has partnered with Lexie Hearing to create a new self-fitted OTC aid for around $900. Over time these prices are likely to fall as more competition enters the market.1,3,5

Walmart, CVS, and Walgreens have made OTC hearing aids available on their websites as of October 17th. Walmart plans to offer a range of various products priced from $199 to $999 per pair and has currently made them available in their vision centers at select stores in Colorado, Michigan, Missouri, Ohio, Pennsylvania, Tennessee, and Texas, and at 474 Sam’s Club Hearing Aid Center locations. CVS plans to have products in stores beginning in November 2022. Walgreens currently has hearing aids available online for $799 with comparable models from specialists ranging from $2,000 to $8,000 per pair. Walgreens also plans to sell these in stores in the future. Hy-Vee plans to start selling over-the-counter hearing aids online and in 34 locations across Iowa, Kansas, Minnesota, Missouri, Nebraska and Wisconsin. Hy-Vee will offer four models ranging in price from $499.99 to $999.99 and plans to make them available in 100 locations by the end of the year.5

Because these products are OTC, pharmacists will not be required to consult on these devices, but they are one of the most accessible healthcare professionals and will need to be able to help consumers in their selection when needed. In some cases, pharmacists will need to refer patients to audiologists and physicians for additional evaluation. They may also need to follow up with patients to ensure the device works as expected. To help pharmacists in this new role, the University of Pittsburgh has developed an online program, available for a fee, to teach pharmacists and pharmacy technicians how to help patients safely choose OTC hearing aids. Continuing education courses will also be produced to help pharmacists in recognizing hearing loss, helping patients in not over amplifying their devices, and much more. 6,8

Sales will be restricted for OTC hearing aids to people 18 years old or older with perceived mild to moderate hearing loss, but there are people to help navigate this new market. The Hearing Loss Association of America published a tip sheet on buying hearing aids. Wirecutter posted a useful guide to selecting various products based on features, which is updated as new products emerge. Johns Hopkins Bloomberg School of Public Health created HearingNumber.org to help people find their level of hearing loss and learn about treatment options. This currently requires an Apple smartphone or tablet, but more options will become available in time.3,1

There are some important things to think about when buying OTC hearing aids. What kind of functions does the device carry, such as Bluetooth capabilities? Are they sweat or water resistant? Do they include rechargeable batteries, or do batteries need to be replaced? What about return policies? There are some standard features that the FDA has made mandatory, such as the ability to adjust the volume, but return policies have been left to the states to decide.4

In the next several months we will likely see many changes coming. People across the country will begin to save hundreds to thousands of dollars while improving their quality of life. This will take time though; more retailers and manufacturers will need to enter the market to see prices continue to drop and to see new innovations arise.

 

Sources:

  1. Hearing aids to be sold over the counter next week | The Seattle Times
  2. Hearing Aids | FDA
  3. FDA Finalizes Historic Rule Enabling Access to Over-the-Counter Hearing Aids for Millions of Americans | FDA
  4. What to Know About Over-the-Counter Hearing Aids – NBC4 Washington (nbcwashington.com)
  5. Hearing aids OTC: CVS, Walgreens, Walmart, Best Buy selling over counter devices (axios.com)
  6. Over-the-counter hearing aids have been greenlighted by the FDA – your local pharmacist will soon be able to sell you the device you need (yahoo.com)
  7. Hearing Aids and Personal Sound Amplification Products: What to Know | FDA
  8. Over-the-Counter Hearing Aids: Everything Pharmacies Need to Know (pbahealth.com)

 

Posted: November 2022

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