SoundControl costs about $ 850, and Bose sells it directly in five states – Massachusetts, Montana, North Carolina, South Carolina and Texas – before becoming available nationally.
Hearing aids are supposed to fit and be controlled by the wearer without the need to see a hearing professional for a hearing test and professional installation.
SoundControl uses standard hearing aid batteries that Bose says can last up to four days if you use 14 hours a day.
The volume and patterns of different listening environments can be previously adjusted via the Bose Hear app for Android and iOS devices.
There is a focus feature with different settings, including a setting to filter noise in crowded rooms and a setting that allows all sounds to arrive while walking outside or around the home.
“Nearly 48 million people suffer from some degree of hearing loss that affects their lives in the United States alone, but the cost and complexity of treatment have become major barriers to getting help,” Bose said.
Prescription hearing aids can cost several thousand dollars and are rarely covered entirely by insurance.
Less expensive personal amplification products are sold in stores, but they are not as effective or adjustable as hearing aids, and are not regulated by the Food and Drug Administration.
The SoundControl hearing aids were the first to be approved by the FDA for use without the assistance of a healthcare provider.
A retro design of Bose hearing aids with self-fitting technology was approved by the FDA with a De Novo rating in 2018, which means it’s a low-risk product, and there are no direct-to-consumer devices like it on the market.
This design had a neck strap and rechargeable battery, but was discontinued last year.
And the new design looks more like traditional hearing aids, in that there is a receiver behind the ear and a small tip is placed in the ear canal, and it was approved by the Food and Drug Administration last week.
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