Self-fitting Bose hearing aid approved for sale

OTC

The US Food and Drug Administration (FDA) has given approval for the marketing of the first self-fitting hearing aid controlled by the wearer. The Bose Hearing Aid received official approval on 5th October from the FDA. This is the first device that users “fit, program, and control on their own, without assistance from a health care provider,” the FDA press release states.

It is estimated that 37.5 million American over the age of 18 report some trouble hearing, ranging from “a little trouble” to “deaf”. The Bose Hearing Aid is a user-fitted wireless air conduction hearing device, which is intended for use by adults only who have mild to moderate hearing loss. Patients can adjust the hearing aid through a mobile application on their phone. This technology enables users to fit and adjust the hearing aid settings themselves, in real-time and in real-world environments without the assistance of a health care professional.

“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. “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. The FDA is committed to ensuring that individuals with hearing loss have options for taking an active role in their health care.”

Prior to authorisation, the FDA reviewed data from clinical studies of 125 patients. The results showed comparable outcomes were achieved through self-fitting and professional fitting of the same device when it comes 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.

The Bose Hearing Aid was reviewed under the FDA’s De Novo premarket review pathway, a regulatory pathway for some low- to moderate-risk devices that are novel and for which there is no prior legally marketed device. The FDA granted marketing authorization of the Bose Hearing Aid device to Bose Corporation. However, the device must comply with federal and state laws regarding the sale of hearing aids; some state laws require hearing aids to be purchased from or dispensed by a licensed hearing aid dispenser.

The product will be marketed as a self-fitting hearing aid, as the FDA is still in the process of drafting proposed regulations for a new category of over-the-counter hearing aids as required by the FDA Reauthorization Act of 2017.

Source: Food and Drugs Administration

V.A.