Over the Counter Hearing Aids: the Real Story

“Do I really need a hearing aids?”

“Is my hearing that bad?”

“I am only here because my kids think I need a hearing aid”

Audiologists hear comments like this throughout their day.

Unfortunately hearing aids have not gained the same mainstream popularity and fashion forward statement that eyeglasses have. Despite the fact that 360 million people worldwide have hearing loss and that nearly 50% of people over 75 years of age have hearing loss, there is still wide spread resistance to trying hearing aids.

Significant research supports the use of hearing aids for people with even a mild hearing loss. Untreated hearing loss can have considerable negative social, psychological, cognitive and health effects.

Studies* have linked untreated hearing loss effects to:

• Irritability, negativism and anger
• Fatigue, tension, stress and depression
• Avoidance or withdrawal from social situations
• Social rejection and loneliness
• Reduced alertness and increased risk to personal safety
• Impaired memory and ability to learn new tasks
• Reduced job performance and earning power
• Diminished psychological and overall health

*Better Hearing Institute

However, the resistance to getting hearing help continues and hearing aid adoption rates are low, especially for those with mild hearing loss. The reasons why are numerous and include:

• Denial: Not understanding (or believing) you have a hearing loss, but instead feeling as if others are mumbling.
• Vanity: Not liking the look of the hearing aid, or believing it makes you look older.
• It’s a hassle: Everyone seems to know someone who has hearing aids but still seem to struggle to hear.
• Finances: Unable to afford the cost of a hearing aid.

In October 2015, The President’s Council on Science and Technology (PCAST) released a report on hearing aids and determined that hearing aids in the current marketplace are not easily accessible to consumers. PCAST believed cost  to be a major issue. They offered recommendations to the President that included the Food and Drug Administration (FDA) creating an “over the counter” (OTC) hearing aid category. The purpose of this is to allow entrepreneurs to be able to bring innovative products to market quickly, without having to go through the red tape currently required to bring a hearing aid, which is classified as a medical device, to market. This should result in innovative products being available more quickly, and at a lower cost, to consumers. In addition, the PCAST suggested that Personal Sound Amplifier Products (PSAPs) - which are currently available and often seen online and in infomercials - to be allowed to make truthful claims about their capabilities, such improving hearing or understanding in situations where environmental noise or crowded rooms might interfere with speech intelligibility. Currently PSAPs may only be marketed to those with normal hearing.  Cleveland Hearing & Speech Center has a high-quality PSAP available to those who may benefit from it.

In November 2016, the Food and Drug Administration voiced their commitment to making OTC hearing aids a reality and Rep. Elizabeth Warren introduced the “Over the Counter Hearing Aid bill of 2016” which would allow for the sale of OTC hearing aids.  Although the bill was not passed prior to the end of the congressional session, it is likely that a similar one will be introduced in the future as the legislation had great support, including the National Academy of Science (NAS), the American Academy of Audiology (AAA), the Academy of Doctors of Audiology(ADA) and the American Speech Language Hearing Association(ASHA).

The support of these professional organizations has come with some caveats including safeguards they recommend the FDA put into place such as:

• Establish limited gain and output thresholds for these hearing aids
• Ensure that OTC hearing aids are only available for adults
• Establish a means for collecting information on consumer safety and other potential complaints
• Require labeling that strongly recommends seeking audiologic diagnostic and rehabilitative services
• Require labels that provide consumers with warning signs for conditions that require medical treatment such as tinnitus, dizziness, drainage from the ear, sudden hearing loss, asymmetric hearing, foreign body in the ear, cerumen impaction, pain, congenital or traumatic deformity of the ear.
• Ensure that current insurance coverage of hearing aids is not undermined. Currently, some states mandate that insurers, including Medicaid, provide coverage for hearing aids for adults. The U.S. Department of Veterans Affairs and the Federal Employees Health Benefits Program also provide coverage for hearing aids. Any new OTC model should not be seen as a substitute for hearing aid benefits under third-party plans.

An overarching reason given for support of legislation for OTC hearing aids is the goal of increasing access to affordable hearing aids and the desire to increase hearing aid adoption rates. However, there is some debate as to whether or not moving to an OTC model will, in fact, accomplish this. EuroTrak and JapanTrak 2012 – 2015 and MarkeTrak 8 and 9 found that Japan, which offers OTC hearing aids has significantly lower levels of adoption than both the UK and the United States which do not currently allow OTC hearing aids sales. (Hearing Aid Adoption rates:  Japan 13%, United Kingdom 41%,  United States 30%.) In addition, levels of satisfaction with hearing aids are lower in Japan (39%) compared to the United States (81%) and the UK (70%).

These lower scores in adoption and satisfaction call into question if improved financial access alone is enough to gain positive outcomes in hearing aid adoption and if moving to an OTC model is in the best interest of public health. This is an area that remains to be proven in the United States. It is safe to say that these changes make for an uncertain time in audiology and hearing healthcare. There is anxiety from professionals and consumers alike about what this will mean and how it will impact them personally and professionally.

As audiologists and providers of hearing healthcare, we know that the professional services that we provide make a difference to the success of our patients. At Cleveland Hearing & Speech Center we track outcomes.  96% of our fittings meet their targeted outcomes as demonstrated by Real Ear testing and we have a 100% satisfaction rate two weeks post-fitting. We feel confident that this would not be the case without our professional services. It is our deep understanding of hearing, hearing loss and the products we dispense that result in successful fittings. CHSC will continue to offer a full range of hearing aids from a variety of manufacturers and the complete package of services to support the consumer. However, we are also committed to ensuring that the hearing aids, even those that are purchased OTC, are fit appropriately and lead to an increased quality of life for the consumer. CHSC is prepared to support consumers who choose to purchase hearing aids or hearing related product from a different vendor, including other audiology practices and retail/online/establishments. Services we will be able to offer include:

• Diagnostic audiologic testing to determine the type and severity of hearing loss and a person’s ability to understand speech in quiet and noise.
• Guidance in choosing an OTC hearing aid or accessories/ couplers for OTC hearing aids that will best meet the needs of the patient and the patient’s hearing loss.
• Customizing OTC hearing aid’s features to best meet the patients hearing loss as able by product.
• Providing custom ear impressions.
• Educating patient on proper use and care of OTC hearing aids or any hearing related product.
• Performing repairs and modifications to hearing aids.
• Completing outcome and verification measures to document successful fittings of hearing aids including Real Ear measurements, aided testing and questionnaires to gauge patient perception of outcomes and satisfaction.

In Feb 2017, Consumer Reports acknowledged that there is a place in the market for less expensive products however, “… it's best to see a licensed, reputable hearing specialist first, to make sure the devices are right for your needs.” We could not agree more.

If you have questions for our CHSC Audiologists concerning your hearing health or hearing aids, please call 216-231-8787 or fill out the form below.