Patients can adjust the hearing aid through a mobile application on their phone. The signal is processed, amplified, and played back through an earphone placed in the ear canal. Air conduction hearing aids work by capturing sound vibrations through one or more microphones. The Bose Hearing Aid is a user-fitted wireless air conduction hearing aid. Individuals with permanent hearing loss can use hearing aids to help them hear the speech and sounds around them better, enabling them to communicate more effectively with others. Hearing loss may be permanent or temporary.
The FDA is committed to ensuring that individuals with hearing loss have options for taking an active role in their health care.”Īpproximately 37.5 million adults aged 18 and over report having some trouble hearing without a hearing aid, ranging from “a little trouble” to “deaf.” Hearing loss can be caused by aging, exposure to loud noises, certain medical conditions and other factors. “Today’s marketing authorization provides certain patients with access to a new hearing aid that provides them with direct control over the fit and functionality of the device. “Hearing loss is a significant public health issue, especially as individuals age,” said Malvina Eydelman, M.D., director of the Division of Ophthalmic, and Ear, Nose and Throat Devices at the FDA's Center for Devices and Radiological Health. This is the first hearing aid authorized for marketing by the FDA that enables users to fit, program and control the hearing aid on their own, without assistance from a health care provider. Food and Drug Administration today allowed marketing of a new device, the Bose Hearing Aid, intended to amplify sounds for individuals 18 years or older with perceived mild to moderate hearing impairment (hearing loss).
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The hearing aids will offer a 90 day trial period and include complimentary virtual setup and offer ongoing support through in-app tips, support videos and video chat or phone call.The U.S. The company provides visitors to its website a comparison table so they can compare how Bose hearing aids stack up against traditional hearing aids and PSAP devices: Click to enlarge Additionally, like most traditional hearing aids, it offers the user the ability to set custom listening programs such as: Restaurant, Music, TV, Outdoors, Airplane.ĭirectional microphones on the hearing aids allow the wearer to change the Focus setting to choose the direction you want to hear – in front or all around.Īccording to the company’s website, the new hearing aids will cost $849.95. The app provides adjustable volume and bass/treble settings to allow the user to set to their personal listening comfort. With CustomTune™ technology, just two controls allow you to set the volume and sound clarity of what you hear to your liking”. They will be available for purchase on May 18 in a limited number of states.īose Hear app is used to adjust the SoundControl™ hearing aidsĪccording to the company, the new hearing aids work in tandem with the Bose Hear app “to provide clinically proven audiologist-quality customization to fit a variety of situations. The devices come in the popular Receiver-In-Canal (RIC) form factor and are powered by a 312 battery.Īccording to the company’s website, the new SoundControl™ hearing aids are intended for perceived mild to moderate hearing loss and are classified as FDA-cleared Class II medical devices. This week, Bose unveiled for the first time its new direct-to-consumer, SoundControl™ hearing aids.