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Back To Vidyya FDA Approves New Implanted Hearing Device

Surgically Implanted Device Is An Alternative To Traditional Hearing Aids

The FDA has approved a new type of surgically implanted hearing device intended to help adults with moderate to severe nerve hearing loss. The device, the first of its kind, is an alternative to traditional hearing aids.

Made by Symphonix Inc., of San Jose, Calif., the device is implanted behind the ear in the temporal (skull) bone. It takes sound and converts it to mechanical energy that is directly transferred to the middle ear. This energy vibrates delicate structures in the middle ear in a manner very similar to normal sound. By contrast, regular hearing aids that are placed inside the ear simply magnify sound.

With the new Vibrant Soundbridge, a receiver is surgically implanted behind the ear. A wire leads down to a small electromagnet attached to one of the middle ear bones. The vibrations are then interpreted as sound by the brain.

In clinical studies, the product was shown to be reasonably safe and effective. While the new product was less visible than some standard hearing aids and did not have associated problems such as ear wax and moisture, implantation of the new device requires surgery and has the risks associated with many surgical procedures.

FDA approval of the implant was based on a review of the clinical study conducted by Symphonix at 10 medical centers in the United States, on supporting data from European studies, and on the recommendation of the Ear, Nose and Throat Panel of FDA's Medical Devices Advisory Committee which met in July to evaluate the product.

In the U.S. study, 81 patients were first tested with hearing aids in both ears and then with the implant in one ear. The patients were followed for at least nine months.

Study results showed that participants could hear about as well with the implant as with hearing aids.

Complications included worsened hearing (2%), permanently altered taste (2%), long-term pain in the ear (5%), and a permanent feeling of fullness in the ear (16%).

Symphonix is conducting an 18-month follow-up study of certain study participants to evaluate the long-term safety and effectiveness of the implant.

The firm has developed two patient information booklets: one for people who may be considering having this device implanted, the other with post-operative care instructions for patients who have had the device implanted.

The Symphonix implant should not be confused with cochlear implants that are intended as a surgical treatment for the profoundly deaf. Cochlear implants are electronic systems that send sound-generated impulses directly to the cochlea, thereby bypassing the middle ear.

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Editor: Susan K. Boyer, RN
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