A newly-approved device could change the way patients manage their hearing loss. Last week, FDA greenlit the Bose Hearing Aid, which is called the first such technology that doesn’t require the assistance of an audiologist or healthcare providers.

The hearing aid was developed by Framingham, MA-based Bose Corp., and is intended to amplify sounds for individuals 18-years or older with perceived mild to moderate hearing impairment (hearing loss.)

“Hearing loss is a significant public health issue, especially as individuals age,” 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, said in a release. “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. FDA is committed to ensuring that individuals with hearing loss have options for taking an active role in their health care.”

The Bose Hearing Aid is a user-fitted wireless air conduction hearing aid. Air conduction hearing aids work by capturing sound vibrations through one or more microphones. The signal is processed, amplified, and played back through an earphone placed in the ear canal. Patients can adjust the hearing aid through a mobile application on their phone. This technology enables users to fit the hearing aid settings themselves, in real-time and in real-world environments without the assistance of a health care professional.

While users may fit, program and control the Bose Hearing Aid on their own, the device must comply with applicable federal and state laws regarding the sale of hearing aids, including state laws that might require hearing aids to be purchased from or dispensed by a licensed hearing aid dispenser. FDA is in the process of drafting proposed regulations for a new category of over-the-counter hearing aids as required.

In authorizing marketing of the Bose device, FDA reviewed data from clinical studies of 125 patients, which demonstrated that outcomes with self-fitting of the Bose Hearing Aid are comparable on average to those with professional fitting of the same device with respect to the amount of amplification selected, speech in noise testing and overall benefit. In addition, when participants self-fit the Bose Hearing Aid, they generally preferred those hearing aid settings over the professionally-selected settings.

The Bose Hearing Aid has been labeled to inform the consumer when to consult a hearing health care professional. News of the Bose Hearing Aid caused shares from hearing aid makers to plunge, according to a report from Bloomberg, on Monday.