New Over the Counter hearing aid law: what you need to know

Hearing loss currently affects around 48 million Americans and can have a substantial impact on a person’s life. But despite untreated hearing loss being linked to an increased risk of depression, dementia and other health issues, only one in five people with hearing loss uses a hearing aid. With hearing aids not usually covered by health insurance, the cost is likely to be a factor stopping people from getting a hearing aid, with prices ranging from $1,000 to $4,000. However, with the introduction of a new over the counter hearing aid law, this could be set to change.

Over the Counter Hearing Aid Act

The Over The Counter Hearing Aid Act was passed in 2017 which has been designed to allow adults with a perceived mild to moderate degree of hearing loss to buy over the counter hearing aids without the need to see a hearing care professional or having a medical referral. Consumers will also not be required to attend multiple appointments and instead, adjust the OTC devices themselves – some of which will be pre-programmed and come with apps.

OTC hearing aid law

This new law was introduced by Senators Elizabeth Warren and Chuck Grassley came swiftly after the scrapping of the 'physician waiver' system which had required consumers to either sign a waiver or see a doctor for a medical evaluation before being eligible to get a hearing aid. The Food & Drug Administration (FDA) is now required to create and regulate a specific group of OTC hearing aids that meet the same quality standards required by all medical devices. This includes:

  1. Providing reasonable assurances of safety and efficacy
  2. Establish output limits and labeling requirements
  3. Describe requirements for the sale of hearing aids in-person, by mail, or online, without a prescription

FDA draft regulations

Final regulations from the FDA are expected to be published either on or before 18 August 2020. Before that, the FDA is expected to issue preliminary guidelines on the sale of over the counter hearing aids, with time allocated for public and industry comments. However, with anticipated concerns to come from hearing care professionals related to competition from unregulated suppliers and potential changes to licensing rules, the publication of the final guidelines could be delayed for several months. It may even be put back until 2021.

What exactly are over the counter hearing aids?

Once the FDA publishes its regulations, we will be able to know a lot more about this new category of hearing aids. However, we do know that OTC hearing aids:

  • Will utilize some of the same technology used in standard hearing aids
  • Will be available online and ‘over the counter’ from retail stores without the need of a medical referral or supervision of a hearing care professional
  • Made available to adults aged 18 and over
  • Will only be for consumers with a mild to moderate hearing loss
  • May be programmed and customized by the wearer
  • May include wireless technologies
  • Could include self-assessment tests

OTC hearing aids and PSAPs

While the bill refers to the OTC devices as ‘hearing aids’, they may not all technically be hearing aids. Many of the hearing devices available over the counter are personal sound amplification products (PSAPs). PSAPs are designed to amplify all sounds while hearing aids are programmed to only amplify the sounds you aren’t able to hear well. With no set definition currently in place for what hearing aid and PSAP mean, the FDA is planning to provide clarification on terminology surrounding OTC hearing aids and hearing devices by spring 2021.

The new over the counter hearing aid law will certainly make hearing aids and other hearing devices far more accessible to more people across the country. However, if you aren’t sure which hearing aid is best for you then you should seek advice from a hearing care professional.

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