InSound Medical Inc announced that the InSound XT Series Hearing Device, the first extended-wear hearing device, has received clearance from the U.S. Food and Drug Administration (FDA) as a treatment for the estimated 28 million Americans with hearing impairment. Designed for all hearing impaired patients, except those with a profound loss, the InSound XT is worn invisibly and continuously, without removal, deep inside the ear canal for up to four months.

According to a recent study by the National Council on Aging, the hearing impaired who do not seek treatment tend to lead less satisfactory lives. Hearing impaired persons ages 50 and over who did not use hearing aids reported significantly higher rates of depression, anxiety, paranoia, reduced social activity and emotional insecurity than those that wore hearing aids.

"By removing the social stigma associated with a visible hearing aid, we expect the InSound XT to provide the hearing impaired with a richer and fuller life," said Adnan Shennib, InSound Medical President and Chief Executive Officer. "The device is so unobtrusive and hassle free that a user can shower, sleep and swim with the device in the ear."

Historically, hearing aid users have been dissatisfied with their hearing aids due to discomfort, sound quality, battery life and conspicuous designs that made it difficult to hide their impairment from others. In fact, approximately 80 per cent of the 28 million hearing impaired individuals in the U.S. have refused to purchase a hearing device of any kind.

"The InSound XT has the potential to overcome many of the problems that currently prevent the hearing-impaired from obtaining hearing devices. It is invisible, comfortable, overcomes the 'hollow sound' associated with previous devices and does away with daily cleaning and frequent battery changes," stated Robert W. Sweetow, Director of Audiology and Professor of Otolaryngology at the University of California, San Francisco Medical Center.

In one visit, the InSound XT is custom-fitted to each patient and then inserted deep in the canal by an otolaryngologist, in collaboration with an audiologist, in a three-minute, non-surgical procedure requiring no anesthesia. The device is placed very close to the eardrum, improving upon the current standard of sound quality by increasing high frequency amplification and minimizing feedback. Upon battery depletion, a new device is re-inserted and the old device is discarded.

"I believe that ENTs, audiologists and, most importantly, patients will herald the arrival of the InSound XT," stated Robert Schindler, Professor and Emeritus Chairman of the Department of Otolaryngology, UCSF. "It is a groundbreaking development for the hearing impaired."

The InSound XT solves the extended-wear challenge through micro-miniaturization and an ultra-low power chip, which requires less than 10 per cent of the energy of conventional hearing aids, extending the lifespan of the battery to up to four months from the typical several days. Clinical studies are ongoing at the University of California, San Francisco and at InSound Medical. The San Francisco Bay area will be the first test market for the InSound XT in 2003.