FDA Allows Buying Hearing Aids Without A Prescription

Millions of Americans will be able to buy hearing aids without a prescription later this fall under the long-awaited rule finalized on Tuesday.

The Food and Drug Administration said the new regulation would reduce bureaucracy by creating a new class of hearing aids that do not require physical examinations, prescriptions or other professional evaluations. Devices are sold online or in pharmacies and other retail outlets.

This device is intended for adults with mild to moderate hearing impairments. The FDA estimates that about 30 million adults could benefit from hearing aids, but currently only about one-fifth of those with hearing impairments use hearing aids.

"His FDA action today marks an important milestone in making hearing aids more cost-effective and accessible," Health and Human Services Secretary Xavier Becerra told reporters on Tuesday. told to

High costs and out of Medicare coverage

The first FDA proposed this rule last year. didand it will go into effect in mid-October. The move follows years of pressure from medical professionals and consumer advocates to make the device cheaper and more readily available.

Cost is now a major obstacle. An American can pay her over $5,000 for hearing aids, including the hearing aids themselves and fitting services. Insurance coverage is limited, and Medicare doesn't pay for hearing aids, only diagnostic tests. Most forms of Medicaid for low-income people also don't cover the cost.

According to White House economic adviser Brian Deese, "The need to see a professional is not only a burden and annoyance for many consumers, but a real competitive barrier to entry."

Deese cited government estimates that Americans could ultimately save as much as $2,800 per pair, but FDA officials said the savings He cautioned against predicting scale or how quickly it can be achieved, noting that it is highly dependent on when manufacturers launch their products and how they are priced.

FDA Medical Device Liability Dr. Jeffrey Shuren, a researcher, said:

However, Shuren said the authorities would not only increase the competition for new products from existing hearing aid manufacturers, but also for new manufacturers. 

Bring iAid?

Companies like Bose, Samsung, and possibly Apple may introduce commercial hearing aids. Dr. Justin Golub, an ear specialist at Columbia University Medical Center in New York City, told CBS news last year that. He added that costs are likely to come down with the entry of Bose. Available for purchase online, Apple announced in 2013 that Bluetooth Started incorporating software .Costco sells hearing aids through its Kirkland brand for approximately $1,400.

} The new over-the-counter status does not apply to devices for more severe hearing loss, only prescriptions. vinegar.

Consumer electronics manufacturers have been making low-cost "personal sound amplification" devices for years, but they have not been FDA reviewed and US regulations have prevented them from being sold as hearing aids. It is prohibited. The new rule clarifies that these devices are not FDA-reviewed replacements for hearing aids.

Tuesday's announcement follows requests from the Medical Commission and Congress that directed the agency to develop a plan for hearing aids on the market in 2017.