You’ve heard the big news about over the counter (OTC) hearing aids.

BUT WHAT DOES IT ALL MEAN?

News outlets everywhere are talking about the new law regarding Over the Counter (OTC) hearing aids.  While the news about OTC hearing aids has definitely grabbed headlines, what does it actually mean for those of us who need help with our hearing?

This law is really nothing new. The OTC hearing aid law was actually passed in 2017. The law was the result of heavy lobbying by Bose, the company we all know for their headphones and home speakers. Bose wanted to sell hearing aids direct to consumers without requiring a hearing test or a professional to fit the device. They got their wish and Bose started selling their OTC hearing aids online in May of 2021. These hearing aids could be “self-tuned” with your smartphone and came at a competitive price.

However, in May of 2022 Bose published a press release stating that they were closing their health division and have laid off their employees in this division following an independent review determining that “Bose should no longer be selling hearing aids.”

So why all the hype right now in August of 2022?  While the OTC law was passed in 2017 it took until this year for the FDA to iron out all the details regarding what would be considered an OTC hearing aid vs a prescription hearing aid and how it could be sold.  Even though these details were just recently finalized, that didn’t stop anyone from selling hearing aids online since 2017.

WHAT ARE OVER-THE-COUNTER (OTC) HEARING AID PRODUCTS?

OTC devices are an upcoming new class of hearing instruments that are specific to the U.S., regulated by the Food and Drug Administration, and approved only for those 18 and older with perceived mild to moderate hearing loss. OTC hearing aids are meant for adults with mild to moderate hearing loss. OTCs will be regulated by the FDA with clear labeling as to use, safety, and efficacy.

WHAT ARE SOME LIMITATIONS OF OTCs?

  • They will only be suitable for mild to moderate hearing loss.
  • Noise processing will be far less than a traditional hearing aid.
  • They won’t always offer a successful fit and will be more of a trial-and-error process.
  • As with any product, you should always read OTC device labels and be aware of problems that can crop up after their use.

Starting in 2017, I have seen patients come into my office with a variety of different hearing aids they have purchased online. Buying hearing aids online or over the counter is nothing new.  While some people may be helped with OTC devices, many experience an improper fit.

WHAT EXACTLY IS A PROPER FIT?

The U.S. Food and Drug Administration defines hearing aids as “sound-amplifying devices designed to aid people who have a hearing impairment.” **

They comprise a microphone, amplifier circuitry, and a receiver. Provider-fit hearing aids have advanced circuitry that can adjust the sound output in real time based on environmental variables like background noise. Furthermore, they can be programmed and finetuned to fit the needs of a specific hearing loss.

Properly fitting a hearing aid is both a science and an art. Even a 1mm difference in the way the hearing aid fits in your ear can affect the sound and change your ability to hear properly with your hearing aids. To truly be successful with hearing aids, we follow a process to ensure the success of our patients and to obtain a proper fit, which provides many benefits.

WHAT ARE THE BENEFITS OF PROVIDER-FIT HEARING AIDS?

  • They are FDA approved and recommended to treat actual hearing loss.
  • An accurate hearing test is conducted to ensure that we prescribe the proper device to meet the needs of that patient.
  • The provider ensures an appropriate physical fit and counsels the patient on adjusting to the devices.
  • The provider rules out other causes of hearing loss, such as earwax buildup, and ensures hearing devices are an appropriate solution for the patient’s situation.
  • They don’t just amplify sound; they adjust to environmental changes to help the brain process sound.
  • Provider follow-ups and clean and checks ensure the devices are working their best for the lifetime of the devices.

WHAT’S BEST FOR PATIENTS?

As noted by a leading consumer advocacy group, the effectiveness of hearing aids can vary by product, so it’s best to have a professional hearing test first, and consider asking an audiologist or hearing aid specialist for guidance in determining which device is right” for an individual’s specific hearing needs.

 


 

**U.S. Food and Drug Administration. Types of Hearing Aids. https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/HomeHealthandConsumer/ConsumerProducts/

HearingAids/ucm181470.htm. Accessed January 8, 2018.

***Consumer Reports. Can PSAPs Help Your Hearing? http://www.consumerreports .org/hearing-ear-care/can-psaps-help-your-hearing/. Accessed April 3, 2017.

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