First Self-Assisted Hearing Aid Device Approved

In a first, the US Food and Drug Administration (FDA) allowed the marketing of a new hearing aid that enables users to fit, program and control it on their own, without assistance from a healthcare provider. Nearly 40 million adults aged 18 and over report having some trouble hearing without a hearing aid, ranging from a little trouble to deaf. “Hearing loss is a significant public health issue, especially as individuals age,” said Malvina Eydelman, Director 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 healthcare,” Eydelman added. Hearing loss can be caused by ageing, exposure to loud noises, certain medical conditions and other factors. It may be permanent or temporary. 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.

The Bose Hearing Aid is a user-fitted wireless air conduction hearing aid which works by capturing sound vibrations through one or more microphones. In the hearing, 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 healthcare professional, the FDA said. For authorizing the marketing, the FDA reviewed data from clinical studies of 125 patients, it noted. These 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. The Bose Hearing Aid has also been labelled to inform the consumer when to consult a hearing healthcare professional. The FDA has granted the marketing authorization of the Bose Hearing Aid device to Bose Corporation. – Business Standard