Bose gets into hearing aid business with new FDA-cleared SoundControl hearing aids – The Verge

Bose announced today that it will begin selling direct-to-consumer SoundControl hearing aids for adults with mild to moderate hearing loss on May 18th. They’ll cost $849.95 and will be sold directly by Bose in five states — Massachusetts, Montana, North Carolina, South Carolina, and Texas — before they’re available nationally.

The hearing aids are meant to be fit and controlled by the wearer without needing to see an audiologist for a hearing test and professional fitting. They use standard hearing aid batteries that Bose says will last up to four days if used 14 hours a day. Volume, treble and bass, and modes for different listening environments can be adjusted and preset in the Bose Hear app on iOS or Android. There’s a “Focus” feature with different settings, including a “Front” setting for filtering noise in busy rooms and an “Everywhere” setting that allows all sounds during walks outside or around the house.

Volume and bass / treble adjustment in the Bose Hear app.

Image: Bose

“In the United States alone, approximately 48 million people suffer from some degree of hearing loss that interferes with their life. But the cost and complexity of treatment have become major barriers to getting help,” said Brian Maguire, category director of Bose Hear, in the press release.

Prescription hearing aids can cost several thousand dollars and are rarely fully covered by insurance. Less costly personal sound amplification products (PSAPs) are sold in stores, but they aren’t as effective or adjustable as hearing aids and aren’t regulated by the Food and Drug Administration. The SoundControl hearing aids are the first to be authorized by the FDA for use without assistance from a health care provider.

An older design for Bose hearing aids with “self-fitting technology” was cleared by the FDA through De Novo classification in 2018, meaning it’s a low-risk product, and there are no direct-to-consumer devices like it on the market. That design had a neckband and a rechargeable battery like Bose’s Hearphones, a hearing amplifier that was discontinued last year. The new design looks more like traditional hearing aids, with a receiver behind the ear and a small tip that sits in the ear canal, and was cleared by the FDA last week based on substantial equivalence to the 2018 De Novo authorization.

Source: https://www.theverge.com/2021/5/11/22430485/bose-soundcontrol-hearing-aid-fda-cleared