Audio manufacturing company Bose Corporation has recently announced the official launch of the first direct-to-consumer, FDA-cleared hearing aids, under the brand SoundControl™, for people with mild to medium hearing loss. The devices, priced at $849.95, will initially be made available for sale by Bose in 5 states, North Carolina, Montana, South Carolina, Massachusetts, and Texas, and will eventually be made available nationwide.
The hearings aids are designed to be fit and operated by the user, without the need for hearing tests or professional fitting from audiologists. They are equipped with standard batteries used for hearing aid, which can last for up to 4 days with 14 hours of use per day according to the company. Bass & treble, volume and modes for various listening situations can be preset and adjusted via the Bose Hear application on Android and iOS.
They also consist of a “Focus” feature with varying settings, which includes a “Front” setting to filter noise in busy surroundings, as well as an “Environment” setting which can allow all sounds around the house or during walks outside.
Category director of Bose Hear, Brian Maguire has reportedly stated that over 48 million people in the United States suffer from hearing loss of some degree, which can interfere with their life. However, he added, the complexity and costs associated with treatments for these conditions have created significant barriers deterring people from getting help.
The SoundControl hearing aids have emerged as a solution for this, as they are the first FDA-authorized hearing aids which can be used without the assistance of healthcare providers.
An older version of Bose’s hearing aids, equipped with “self-fitting technology” had earned De Novo classification from the FDA in 2018, which means they were considered low-risk products with no similar direct-to-consumer devices in the market. The new design, which resembles traditional hearing aids with receivers behind the ears and small tips that sit in the ear canal, received FDA-clearance based on considerable equivalence to this 2018 De Novo authorization.