It is considered a breakthrough that the US Food and Drug Administration has announced that hearing aids will be sold over-the-counter (OTC) as early as mid-October. The announcement of this final decision came on August 16, 2022 after President Biden’s Executive Order on Promoting Competition in the U.S. Economy to Make Health Care Costs More Affordable resulted in a 120-day delay in action. days.
Key points to remember
- The FDA decision will make hearing aids more affordable and readily available.
- Tens of millions of Americans suffer from hearing loss but have been left out.
- List of manufacturers and retailers below who could benefit from the ruling.
Hearing loss can affect anyone, and it’s a travesty that so many people have had to live with poor hearing for so long. In the United States, nearly half of people over the age of 65 have some degree of hearing loss. Besides age, hearing loss is usually caused by exposure to loud noise or a handful of medical conditions. People with permanent hearing loss can use hearing aids to make the sounds and speech around them louder, allowing better communication, but the effects are mostly irreversible.
What the decision changes
The new FDA decision is historic as it has been reported that 28.8 million American adults could benefit from hearing aids. With approximately 15% of American adults suffering from hearing loss, it is clear that an over-the-counter product will help many people who previously could not afford hearing aids. As a result, stocks and hearing aid companies expect a belated increase in revenue.
Millions of Americans had to spend too much money to go through the necessary medical process to get hearing aids or simply never bought them due to inaccessibility issues. In fact, the complicated process of buying hearing aids was the biggest hurdle for many who needed them.
The process involves consulting with an audiologist and then arranging a time to properly fit the devices. But now the new FDA ruling will allow adults with mild to moderate hearing loss to buy devices from retailers without a medical exam, prescription or fitting. Many companies are starting to offer hearing tests online, so one can invest in a pair of hearing aids without leaving the comfort of their own home.
The FDA will still regulate the quality of these OTC hearing aids to ensure consumer safety.
Which retailers will be the first to offer OTC hearing aids?
As soon as the FDA announced the final decision, given the scope of those affected, there was an outpouring of interest in where to buy the products. The biggest question for people affected by hearing loss – and for the savvy investor – is which retailers will first bring these over-the-counter hearing aids to consumers.
Here are some of the first retailers supposed to offer over-the-counter hearing aids.
- RESUME : Although it has sold hearing amplifiers for the past few years, CVS will begin offering OTC hearing aids once the FDA ruling takes effect in mid-October.
- Walmart: With its expansion into drugstore-related products, Walmart plans to add over-the-counter hearing aids in mid-October.
- Best buy: As soon as the FDA approved OTC hearing aids, Best Buy announced that we could expect to see hearing aids in stores. Best Buy already sells other hearing aids, including TV amplifiers, personal sound amplification devices and hearing protection devices.
- Direct to consumer: Many companies offer OTC hearing aid products directly to consumers. It’s unclear which vendors will enter this market, but expect to see names like Eargo, Lively and Audicus more regularly.
This new class of devices will provide options for people who may have been left out of the hearing aid market. It’s also worth mentioning that many retailers have said that the new OTC hearing aids will be available online so you don’t even have to go to the store to get your device.
More remarkably, this new FDA decision is expected to drive innovation in hearing aids and related products. New entrants to this market could disrupt existing competition. Watching tech companies like Apple and Samsung will be fascinating as they aim to improve products to benefit people with hearing problems.
For example, Apple’s Conversation Boost feature on AirPods Pro helps you distinguish speech in noisy environments. It’s unclear what other innovations might come from this decision and where one might find the perfect hearing product for their situation.
Costs of purchasing hearing aids for the consumer
It is well known that cost was the main factor preventing many Americans from buying hearing aids. According to this release from the White House, hearing aids averaged more than $5,000 a pair. The statement also said that due to the high price of hearing aids, only 14% of the approximately 48 million Americans who needed hearing aids bought them.
The good news is that OTC hearing aids cost between $300 and $600 per device, according to the American Academy of Audiology. This significant price drop should lead to increased sales of hearing aids to those who desperately need them.
Top Hearing Aid Manufacturers
- Listen : Eargo said its hearing aids are rechargeable and virtually invisible. All hearing aids come with a portable charger, USB plug and cable, wax guard and cleaning brush.
- Animated: Lively sells one type of hearing aid with rechargeable and battery-powered models in different colors. This company has been offering hearing aids through an online hearing test since 2019.
- Touch Star: Starkey offers hearing aids that double as health and wellness trackers. It also provides an app that can control the device.
- MDHearingAid: This company sells medical-grade hearing aids that are FDA-approved according to the current standard. They offer a range of models that won’t break the bank.
- Sign : Signia is one of the world’s leading hearing aid brands. It offers various hearing aids, starting at just $1,000.
Buying a hearing aid for the first time can be a complicated process. When comparing different brands and models, consider these factors:
- Price ranges and payment plan options
- Product quality
- Availability of hearing tests
- Product durability (e.g. rechargeable)
- FDA approval
What hearing aid stocks are worth checking out?
As hearing aids become more accessible to Americans, sales are expected to increase dramatically. You might want to consider investing in hearing aid stocks to take advantage of this sales bonanza.
Eargo Inc. (EAR)
Eargo is a medical device company looking to take advantage of this new opportunity in the hearing aid market. This company offers fully rechargeable hearing aids which are all FDA approved. It also offers free hearing screenings and online appointments with a hearing expert for anyone who buys an Eargo hearing aid.
Eargo went public in October 2020 and its shares have since fallen due to market volatility. Still, as the new ruling is expected to increase access to hearing aids for tens of millions of Americans, it may be worth investing in this penny stock.
Knowles Society (KN)
Knowles manufactures electronic parts for hearing aids, including microphones, receivers and programmable components. The company also manufactures products for mobile devices, headphones and other mobile communication devices.
With the increasing demand and availability of hearing aids, this company is expected to increase production. And because Knowles is involved in other communications product industries, the company has a diverse revenue stream.
Sonova Holding SA (SONVY)
This Swiss company is the largest hearing aid manufacturer in the world and a respected brand worth investing in. Sonova currently markets its products under four businesses and five primary brands, as well as various regional brands in the United States and globally.
Sonova is an over-the-counter stock, which means there is less regulation and additional risk to consider. However, its established global presence and strong financial track record make it a stock worth considering.
Energizer Holdings, Inc. (ENR)
Energizer is one of the largest battery manufacturers in the world and a household name. Rayovac, a subsidiary of Energizer, has been manufacturing hearing aid batteries for over 50 years and the company guarantees that no other hearing aid battery can last longer.
As hearing aids become more accessible, the demand for these different types of batteries is expected to increase accordingly.
The Final Word on Hearing Aid Stocks
The new FDA ruling will allow people to access affordable hearing aids, which is expected to significantly increase demand for this and related products. Now may be a good time to invest in hearing aid stocks as companies focus on increasing supply to meet demand.
If you’re unsure which hearing aid stocks are the best fit for your portfolio, you can always choose a technology-focused Q.ai investment kit, a simple way to diversify your investments and limit risk.
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