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The U.S. Food and Drug Administration Clears BAHA® for a New Indication in Treating Single-Sided Deafness (SSD)


Powell, Ohio - The U.S. Food and Drug Administration has cleared the BAHA®, by Entific Medical Systems, to be used in a new indication to treat Single-Sided Deafness (SSD). Studies conducted by Johns Hopkins University, House Ear Institute, Columbia University College of Physicians and Surgeons and several prestigious European hospitals have concluded positive results with high overall patient satisfaction.

In the U.S. alone, over 60,000 people per year become victims of SSD through sudden deafness with examples such as; viral infections, Meniere's disease, trauma, measles, chicken pox, acoustic neuroma tumors and surgical intervention. Most patients inflicted by a form of SSD have been left without a choice or an adequate solution to help them. BAHA, now an FDA cleared solution for SSD, provides a completely unique benefit.

Most people who have not experienced SSD do not realize the handicaps that are presented when this loss occurs. The harsh reality is that many with SSD have to make major life changes. These life changes may include ending everyday things such as; crossing the street, business meetings, restaurants, family gatherings, bicycling or driving a car.

With SSD, it is no longer possible to differentiate where sound comes from; this is a serious safety issue. In group situations, loud sounds become overwhelming and the simplest things in life become major obstacles which in many cases lead to the individual removing themselves socially and professionally.

To help people with SSD, the BAHA device is placed on the deaf ear side behind the ear, and transfers sound through bone conduction, stimulating the cochlea from the normal hearing ear. BAHA gives the possibility to hear and understand sounds from both sides of the head where previously the head shadow effect totally masked certain sounds. This ultimately results in the sensation of hearing from the deaf ear.

The BAHA system is a safe, proven and predictable solution for people who need hearing amplification but have ear canal or middle ear problems. BAHA works through true bone conduction, i.e. the bone acts as a pathway for the sound to travel to a functioning inner ear (cochlea), without involving the ear canal or middle ear. In BAHA treatment, the sound is transferred from the sound processor via an external abutment to a small titanium fixture, which is placed in the skull bone behind the ear. In this way, the vibrating transducer inside the sound processor is directly connected to the skull of which the inner ear is an integral part. Placing a fixture and an abutment in the skull bone is seen as a minor surgical procedure and is usually done under local anesthesia. In 1996 BAHA was cleared by the FDA for use in the United States to treat mixed and conductive hearing loss. Then in 1999, the FDA extended the indications for use to include treating children 5 years of age and above. Now, through newly expanded indications, BAHA has been cleared by the FDA for use in patients with Single-Sided Deafness. BAHA has been used successfully around the world by patients since 1977.

Entific Medical Systems focuses on hearing and facial rehabilitation, improving the quality of life for people all over the world. Our solutions create opportunity and instill confidence in many wearers.

Entific is a fast growing international company based in Sweden, represented by local offices throughout North America and Europe. There are also appointed distributors in other parts of the world. Formerly, a part of Nobel Biocare, Entific has been an independent company since 1999. The company manufactures and distributes two major product groups; BAHA® and Face to Face™. They are based on osseointegration; titanium implants integrated with living bone tissue. Both product systems have FDA clearance and are carrying the CE Mark.
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