The US Food and Drug Administration (FDA) granted authorisation for Bose Corporation to market its Bose Hearing Aid device for mild to moderate hearing impairment in people aged 18 years or above.
The new device is said to be the first FDA-cleared self-fitting hearing aid. It allows users to fit, programme and control the hearing aid, avoiding the need for assistance from a health care provider.
Bose Hearing Aid leverages wireless air conduction that involves capturing sound vibrations using one or more microphones. This signal is processed, amplified and played back via an earphone placed in the ear canal.
Patients can adjust the hearing aid settings through a mobile application in real-time and in real-world environments. The device also informs the consumer when to consult a healthcare professional.
FDA Division of Ophthalmic, and Ear, Nose and Throat Devices director Malvina Eydelman said: “Today’s marketing authorisation 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.”
The FDA clearance is based on findings from clinical studies conducted in a total of 125 patients.
Data showed that outcomes with self-fitting Bose Hearing Aid are on average comparable to those with a professional fitting of the same device in terms of the amount of amplification selected, speech in noise testing and overall benefit.