Call nowMessage
OurSeniors.net - Senior with Hearing Aids

Important News for Seniors- FDA Soon to Allow Over-the-Counter Hearing Aids

OurSeniors.net-Important News for Seniors- FDA Soon to Allow Over-the-Counter Hearing Aids

OurSeniors.Net and our magazine for seniors both exist to serve the needs of seniors. Affordable healthcare of all kinds is one of the most important of those needs. This includes not only general health but also vision and hearing problems. Hearing loss affects an estimated 30 million people in the United States. Approximately one in three people aged 65 to 74 have some loss of hearing. About one-half of those older than 75 have difficulty hearing.

Many hearing loss problems can be significantly improved or eliminated using hearing aids. Modern technology has dramatically enhanced these devices. They are easier to use, more effective and less intrusive than ever before. Unfortunately, they are also more expensive than before. Despite the frequency and the serious nature of hearing loss, only about one-fifth of the people who could benefit from a hearing aid go through the process of diagnosis, prescription and purchase.

Of course, one of the main reasons is the high cost of hearing aids and the associated services required. In the past, the cost for a single hearing aid ranged from hundreds of dollars to over four thousand dollars. Keep in mind that many people need not one, but two hearing aids. A significant portion of the total cost has been the professional audiology services bundled into the total package. This package deal has included the retail price of the device, the professional services required to program and fit the device, and a repair and maintenance agreement. It is not surprising that these high prices have prevented many seniors from buying a much-needed hearing aid.

The United States Food and Drug Administration (the FDA) is best known for its regulatory authority over prescription and non-prescription drugs. It also regulates medical devices such as artificial hips, pacemakers and hearing aids. The FDA is now proposing that a new class of hearing aid devices should be established, one that will allow seniors to buy hearing aids without medical exams, audiology testing and other requirements. As long ago as 2015, the President’s Council on Science and Technology recommended this action. The Council noted that requirements for exams and testing provided little patient benefit while acting as a barrier to access for millions needing hearing assistance.

This rule change is going to open a new world of possibilities for innovators and hearing-impaired people. The cost of hearing devices could drop as much as 90%. How could this simple rule change make this possible? Right now, hearing aids are a niche market with relatively few suppliers. Buying a hearing aid has usually been a medical model. It started with a doctor who referred to an audiologist, who administered tests, then chose and fitted the hearing aid for the patient. The new model is direct sales from manufacturers to consumers.

The proposed new rule was published in October 2021, and it must be finalized no later than July 17, 2022. On April 8, Senators Chuck Grassley (R-Iowa) and Elizabeth Warren (D-Mass.) filed a bill in the U.S. Senate that requires the FDA to issue a rule within 30 days of the measure’s enactment. This additional prodding may speed up the process.

Being able to market FDA-regulated hearing aids directly to the consumer should bring in numerous new products, often from well-known names like Bose, Google, Apple, Samsung and others. Innovative ways of testing hearing like Apple or Google “apps” on phones and computers are likely to appear. The necessity for expensive in-office audiology tests will be sharply reduced. Likely, these new hearing aids

will soon be capable of connecting to the internet, making phone calls, summoning emergency help, and adjusting themselves to individual needs and the sound conditions around the user.

This new rule will allow the merging of consumer devices and health care to speed up. It has already begun with familiar items like the Apple Watch which can now monitor some vital signs (and many more in the future). Consumers, especially seniors, are going to be the beneficiaries of these changes which will make regulated hearing aids available at lower cost and without unnecessary medical tests. All of this is important news for seniors, including those living in Florida. However, there is a note of caution our senior living magazine should pass along.

Seniors should know the difference between hearing aids and Personal Sound Amplification Products or PSAPs. Currently, hearing aids” regulated by the FDA are sold by audiologists or ear, nose and throat doctors. In some states, licensed sellers called “instrument specialistscan do this. This new category of FDA-regulated hearing aids will reduce costs and make these instruments available to buy in a store or online without seeing a physician for an exam or an audiologist for help with fitting. After the new FDA regulations are completed, these hearing aids will become available nationwide. The new OTC rules will apply to certain hearing aids intended for people who have mild to moderate hearing loss. These people may hear some speech sounds but not others, or they may hear almost no speech spoken at a normal level.

Personal sound amplification products (PSAPs) are not alternatives to hearing aids. PSAPs are intended for people with normal hearing; they are used to amplify sounds in certain situations like hunting or at large social gatherings. Because they are not intended to be medical devices, they are not regulated by the FDA and their quality and dependability may vary greatly. You have probably seen ads for these devices on TV or in senior magazines. Be sure to read these ads carefully; some try to give the impression that they are medicalgrade hearing aids when they are not. Make sure the device is FDA Regulated,” not “FDA Registered. Registration with the FDA does not mean that it is approved or sanctioned by that agency. When the new, over-the-counter class of FDA-approved aids becomes available, FDA approval will be clearly stated.

OurSeniors.Net hopes this important news for seniors is helpful. That is the purpose of our organization and our senior living magazine as well. Please return here often and count on us for senior living resources.

Scroll to top