FDA ruling would allow sale of counter hearing aids

During a special announcement the FDA Food and Drug Administration said that with immediate entry into force, no longer be required people get a medical checkup before buying most hearing aids. Do you like what you are reading? Receive similar content direct to your email.


Loss of hearing

The announcement was made at a public meeting of the National Academies of Sciences, Engineering and Medicine. Prior recommendations from this group, as well as a White House advisory panel on science and technology, and some groups of consumers and audiologists have strongly suggested removing this restriction as long as the hearing aids are more affordable and accessible.


Three easy ways to find answers to frequently asked questions. Become a member of AARP today and get access to benefits, information and exclusive discounts. The decision does not apply to young people 18 years of age or younger who still need to have a medical checkup before they can buy hearing aids. It also does not apply to bone conduction hearing aids or hearing aids that are inserted deep into the ear canal.

The hearing loss affects approximately 30 million people in the United States, and not only affects their performance at work and social interactions, but the overall health and quality of life. The isolation and loneliness that can result from severe hearing loss may cause a higher risk of cognitive decline and dementia.

Despite the high prevalence of hearing loss and its impact on public health, only about a fifth of people who would benefit from using a hearing aid actually use it, the FDA said. The high cost of the devices about $ 4,600 a pair – has been a major obstacle. Medicare and many private insurance plans do not cover the cost of hearing aids so most consumers end up paying for them out of their own pocket. In addition, six companies manufacture almost all hearing aids on the market, and only one of them is based in the United States, according to a White House blog post on the FDA’s decision.

The impact of the FDA decision could open the hearing aid market to new businesses and more competition. Today’s measures are an example of the flexible strategies that the FDA is considering to reach a regulation that encourages innovation in areas of accelerated scientific progress said FDA Commissioner Dr. Robert Califf.