Release: Embargoed until September 24, 2000Contact: Kenneth Satterfield202-371-4517 (9/23-27)703-519-1563[email protected]
THE VIBRANT SOUNDBRIDGE PROVIDES AN EFFECTIVE ALTERNATIVE TO HEARING AIDS
A new study suggests that a partially implantable device may be the solution for those who refuse to wear hearing aids
Washington, DC -- There are millions of young to middle age men and women with moderate to severe sensorineural hearing loss who would benefit from wearing hearing aids. Despite their obvious need, these candidates for hearing improvement are dissatisfied with traditional hearing aids.
Marketing research shows that customer satisfaction has not improved since 1991 and 16 percent of owners don't wear their hearing aids. Hearing aid market penetration is at an all time low even with the emergence of digital technology. The top five reasons that hearing aid utilization has not improved are (1) no benefit achieved; (2) background noise heard; (3) poor fit and comfort; (4) a wide range of negative side effects; and (5) price and associated costs.
A new research study offers early hearing results of the "Vibrant Soundbridge," a new device that is designed to overcome the shortcomings of hearing aids. It is a partially implantable device that allows the ear canal to be open and directly drives a bone of hearing in the middle ear. The theoretical advantages of a direct drive device are improved sound quality, reduction in feedback, elimination of occlusion and improved comfort.
The FDA approved the Soundbridge for adults with moderate to severe sensorineural hearing loss who desire an alternative to a hearing aid. The device is implanted in a routine two-hour surgical procedure. The audio processor is worn behind the ear with magnetic attraction to the direct drive internal device. It is powered by a zinc air battery, is very lightweight, and is invisible in the temporal hairline.
The authors of the study, "The Symphonix Vibrant Soundbridge: The Surgical Treatment of Sensorineural Hearing Loss," are Jennifer L. Maw, MD, from San Jose, CA, and Charles M. Luetje, MD, from Kansas City, MO. Their findings will be presented September 25, 2000, at the Annual Meeting/Oto Expo of the American Academy of Otolaryngology--Head and Neck Surgery Foundation, being held September 24-27, at the Washington, DC Convention Center.
Methodology: Twenty-nine patients were accepted for implantation of the device according to the multicenter FDA study criteria. All patients had bilateral, symmetric, stable, moderate to severe sensorineural hearing loss with speech discrimination scores of at least 50 percent without evidence of middle ear disease. All the subjects wore hearing aids that were appropriately fitted and were dissatisfied with their function.
Results: Twenty-nine patients underwent implantation of the Vibrant Soundbridge device. All patients underwent implantation of the Vibrant Soundbridge device into one ear. The main outcome measures include preoperative and postoperative pure-tone air and bone conduction thresholds, speech discrimination scores, functional gain, speech in noise tests, and patient satisfaction scores.
There were no surgical complications and no significant changes in residual hearing. All patients obtained satisfying functional gain using their device and preferred use of the implant over their hearing aids. Other findings included:
--Only five percent of the subjects were satisfied with their hearing aids in respect to background noise; 70 percent were satisfied with the Soundbridge in respect to this criteria.--There was significant improvement in functional gain in high frequencies following implantation of the Soundbridge device.--The subjects reported high satisfaction with the overall sound quality of the new device.--There were no significant changes in residual hearing or complications in the group.
Conclusions: The study demonstrates with early testing, that patients are far more satisfied with the Soundbridge device than conventional hearing aids. The results indicate that alternative devices to assist hearing may be attractive to the growing number of Americans with sensorineural hearing loss.
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