Implant Manufacturer Closes Its Doors Symphonix Devices became the first manufacturer of a middle-ear implant to gain approval from the U.S. Food and Drug Administration (FDA) in 2000, but less than two years later, the company closed its doors, leaving behind questions about the viability of the technology in the marketplace. Middle-ear implants (MEIs) are ... Features
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Features  |   February 01, 2003
Implant Manufacturer Closes Its Doors
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Hearing Disorders / Hearing Aids, Cochlear Implants & Assistive Technology / Practice Management / Professional Issues & Training / Regulatory, Legislative & Advocacy / Features
Features   |   February 01, 2003
Implant Manufacturer Closes Its Doors
The ASHA Leader, February 2003, Vol. 8, 2-9. doi:10.1044/leader.FTR5.08032003.2
The ASHA Leader, February 2003, Vol. 8, 2-9. doi:10.1044/leader.FTR5.08032003.2
Symphonix Devices became the first manufacturer of a middle-ear implant to gain approval from the U.S. Food and Drug Administration (FDA) in 2000, but less than two years later, the company closed its doors, leaving behind questions about the viability of the technology in the marketplace.
Middle-ear implants (MEIs) are an alternative to conventional hearing aids for those with mild-to-severe hearing loss. The implants drive the ossicular chain directly, sending vibrational energy to the cochlea, resulting in reduced occlusion, feedback, and increased high frequency functional gain. Today, there is currently one other FDA approved MEI, and several other devices in clinical trials in the United States. Worldwide, approximately 1,700 patients have received an approved MEI, and about half have the Symphonix device.
Founded in 1994, Symphonix Devices announced the dissolution of its business in 2002 despite the financial backing of a hearing aid manufacturer and favorable insurance coverage decisions.
“The slow market adoption of the Vibrant Soundbridge combined with the difficult current financing environment has led us to make this very difficult decision. However, upon careful consideration from our directors, officers, and advisors, we believe that this action is in the best interests of our stockholders,” said Kirk Davis, Symphonix CEO and director, in a press release.
Symphonix has pledged to support current patients and clinicians by providing repair and replacement of the external audio processor and offering professional support to audiologists, and has already developed the next generation implant and audio processor. The company is seeking a purchaser with the capability and interest in developing the technology and providing support for the current device and patient base, said Debra Arthur, an audiologist and vice president of regulatory affairs for Symphonix.
“Symphonix was a product ahead of its time,” Arthur said. “We were unable to achieve the financial growth needed to support the product. Unfortunately, I think it’s going to have an impact on the ability of other manufacturers to progress in as rapid a manner as they had anticipated. My hope is that the hearing health care community does not become reluctant to embrace the middle-ear implant for those patients where it is appropriate.”
The news of the company’s dissolution took audiologists by surprise. Rebecca Levy, an audiologist, was investigating the possibility of offering the MEI at the Washington Audiology and Imaging Center in the District of Columbia.
“I was surprised and saddened to hear that Symphonix would no longer be in business because I think the idea of middle-ear implants is a good one,” said Levy, who was involved with a clinical trial for a MEI while on the staff at the University of Texas Southwestern Medical Center. All six patients in the trial liked the device, Levy said. “Unfortunately, middle-ear implants are still too new of a concept to withstand the hit of a main manufacturer going out of business not much more than a year after gaining FDA approval.”
The decision came after the company won favorable coverage decisions from both private and public payers. Aetna, one of the nation’s largest health insurance plans with 11.9 million subscribers, decided to cover the MEI device and surgery as part of its plans that include hearing aid benefits when medical necessity is determined. Another 19 insurance carriers provided coverage on a case-by-case basis.
The Veterans Administration (VA) was set to launch a pilot program in fall 2002 that would offer the MEI to veterans in San Francisco, paving the way to broader adoption of the device within the VA system.
But the lack of widespread insurance coverage for MEIs was a major barrier in recruiting patients after the FDA clinical trial ended, said Paul Kileny, director of audiology and electrophysiology at the University of Michigan Health System, who has worked with two different MEIs. “This is hardly a surprise since there are relatively few plans providing coverage for conventional amplification devices, which is an even greater problem,” Kileny said. “While middle-ear amplification devices have some advantages—lack of occlusion and more natural sound as reported by some patients—most patients have a relatively lower-cost alternative: a well-fitted conventional hearing aid.”
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February 2003
Volume 8, Issue 3