Editor: We’ve been hearing about totally implantable hearing aids for a while now, and they’re finally here! They’re still experimental, but they are being implanted now. Some of the claims in the press release may be a bit exaggerated – I’ll need to see the evidence before I believe some of it – but I do believe that implantable hearing aids hold great promise.
March 2002 – Here’s information on the Phase One trial of Envoy Implantable System from St. Croix Medical Inc.
September 2004 – And now, the Envoy is undergoing Phase 2 trials!
Envoy Implantable Aid Phase One Trial
A team of ear surgeons at Allegheny General Hospital (AGH) has become the first in the United States to use a revolutionary, completely implantable hearing restoration system that promises to greatly improve the hearing capacity of those who suffer from mild to severe sensorineural hearing deficits, the most common form of hearing loss – associated with aging or exposure to loud noise.
An estimated 10 million of the 30 million Americans living with sensorineural hearing loss would be considered good candidates for the new therapy.
Pioneered by St. Croix Medical Inc., in Minneapolis, MN, the Envoy Middle Ear Implantable System has been tested in Germany for the past year and was just recently cleared by the Food and Drug Administration for study in the U.S.
The Envoy technology is the only totally implantable hearing restoration system in the world and AGH is one of two U.S. medical centers that will investigate the technology in a phase one clinical trial, joining the Virginia Mason Hearing for Life Center in Seattle, Washington.
The investigation is being co-directed at AGH by nationally renowned ear surgeons Moises Arriaga, M.D., and Douglas Chen, M.D., who are also co-directors of the hospital’s Hearing and Balance Center.
Last week, a 66-year-old North Side man became the first person in the U.S. to receive the Envoy System, followed by three other patients, a 73-year-old man from Wabash, a 58-year-old woman from Greensburg and a 63-year-old man from Johnstown. The systems will be activated for the first time in approximately six to eight weeks after healing from the surgical procedure.
According to Arriaga, excitement over the Envoy System centers around its potential for both eliminating problems associated with conventional, externally worn hearing aids, such as background noise, acoustic feedback, ear canal occlusion and signal distortion, and its application to a large number of people whose hearing loss threshold is beyond the reach of current devices.
The potential for improved sound quality with the Envoy system combined with the technology’s invisibility could significantly increase the number of people who seek assistance for their hearing loss, Arriaga said. Currently, only 10-20 percent of those considered good candidates for hearing aids use them.
“For most people who suffer from sensorineural hearing loss, hearing aids can provide significant quality of life improvement. The problem with conventional devices, however, is twofold; people often don’t like how they look or feel and the overall sound quality is fairly limited. Additionally, for those whose hearing loss threshold is greater than 55 decibels, conventional devices are typically ineffective, leaving us with few therapeutic options,” Arriaga said.
Conventional hearing aids conduct sound using directional microphones that often pick up sound from sources other than what the user is focused on, making it difficult to understand and interpret background noise. In contrast, the Envoy System employs the body’s own eardrum as its microphone, using the natural acoustics of the ear canal without obstruction, interference or any external devices. The input signals are thus identical to those received by a person with normal hearing, allowing for much better sound transmission and comprehension.
“The Envoy System clearly promises to take the field of hearing restoration to a new level and its impact could be tremendous in terms of the number of people with hearing loss who stand to benefit. The advanced design and engineering of the technology should allow us in most cases to return victims of sensorineural hearing loss to normal or very close to normal hearing levels.
I believe it will become the standard by which all future hearing restoration technology is based,” said Chen.
Utilizing technology and components contained in implantable cardiac pacemakers, the Envoy System employs state-of-the-art, biocompatible piezoelectric transducers to detect and reproduce sound vibrations of the middle ear bones. Two transducers, the Sensor and Driver, are mounted to the middle ear bones and connected via fatigue-resistant wires to a separate electronic unit implanted in the occipital bone behind the ear that consists of a programmable sound processor and power source.
The Sensor detects sound vibrations from the tympanic membrane through the malleus and incus bones. The system converts those vibrations into electrical signals that are amplified, filtered and transmitted as mechanical vibrations through the Driver to the stapes bone. The signal is then delivered via the stapes bone to the inner ear where it is converted into nerve impulses and translated into words or sound by the brain.
The Envoy System is powered by a pacemaker-type lithium battery with a projected life-span of approximately five years. When the battery begins to weaken, the implantable sound processor/power source can be replaced independent of the more deeply implanted transducers, a procedure that can be done on an outpatient basis under local anesthesia.
The Envoy System’s electronics circuit is programmable with radio frequency telemetry and is comprised of bandpass amplifiers with frequency responses controlled via physician or audiologist programming to fit a patient’s specific hearing loss profile. The system provides adjustable gain and volume control, a configuration that allows the hearing loss compensation for high frequency loss to be independent of the compensation for low frequency loss. This compression feature optimizes the device’s function in changing environments, such as moving from noisy situations to quiet situations.
Patients also have the ability to remotely program the implanted system with a pocket sized programmer to adjust the volume, place the unit in standby for sleep and select one of three programmed settings, which have been individually tailored to the patient. Programmed settings can be changed at any time by the audiologist or physician to help patients adapt to the new sound or hearing performance changes.
Approximately 10 patients will be enrolled in the phase one study of the Envoy System, with an expanded phase two study to commence shortly after pending FDA approval, said Doug Hoag, spokesman for St. Croix.
Totally Implantable Envoy in Clinical Trials
Editor: We’ve been following the story of the Envoy totally implantable hearing aid for a couple of years now, and are excited to see that they are in clinical trials. The technology (described towards the end of the article) is pretty interesting. If any of our readers are part of this trial, I’d love to hear your thoughts about this system.
From the newsroom of the Business Wire, Tuesday, September 7, 2004
St. Croix Medical, Inc. Announces Advancements in US and German Pivotal Clinical Studies
Totally implantable Envoy(R) System restores quality of life in patients with hearing loss
MINNEAPOLIS — St. Croix Medical, Inc. (SCM) announced today that its Envoy System has been implanted in several patients as part of the product’s pivotal clinical study. This study follows an earlier study and will evaluate the safety and effectiveness of the company’s device in patients with sensorineural hearing loss on a larger scale. Physicians in Greensboro, NC, Newport Beach, CA, Pittsburgh, PA and Koblenz, Germany have performed the first procedures.
“The enrollment of these patients in the US and German clinical trials is another step towards meeting the European and FDA requirements for market approval,” said Hans Neisz, SCM’s President and Chief Executive Officer. Neisz continued, “The preliminary results are very encouraging and endorse the system’s capabilities to provide benefit to patients whose life is compromised or debilitated by their hearing loss.”
Over 21.5 million adults in the United States suffer from sensorineural hearing loss. Conventional microphone-based hearing aids are the most common treatment today for sensorineural hearing loss. However, only 20 to 30% of the hearing impaired use hearing aids and many who try hearing aids stop after a short period. The most commonly sited limitations of hearing aids include poor understanding in noise, poor sound quality, whistling (acoustic feedback), battery life, poor fit and discomfort.
The technology platform of the Envoy System is different from all other microphone-based hearing devices (hearing aids, other middle ear implants or cochlear implants). The Envoy uses the eardrum to process the incoming sound and thereby preserving a natural way of hearing that particularly benefits patients in noisy environments.
Piezoelectric transducers sense minute mechanical vibrations at the eardrum and convert them into electrical signals. These electrical signals are then amplified and filtered by a “pacemaker-like” sound processor and transmitted to a second piezoelectric transducer that stimulates the inner ear naturally, and with significantly greater efficiency than acoustic devices. The Envoy System is the only hearing device that leverages the natural anatomical function of the ear and is expected to result in better clarity of sound, better word recognition and reduction of background noise. The proprietary microelectronics of the Envoy consumes a very small amount of electrical current, allowing the device to function for up to 4 years without maintenance. Being totally implantable, the Envoy System is invisible to the onlooker and eliminates the stigma that is often associated with hearing impairment.
SCM received an Investigational Device Exemption from the FDA, has completed Phase I clinical trials and is now actively enrolling patients to participate in the Phase II pivotal trial in both the United States and Germany.
SCM was founded in 1995 to design, develop and market implantable devices for the treatment of sensory disorders. A privately held, Minnesota-based company, the current focus of the organization is to improve the quality of life for the millions of individuals suffering from sensorineural hearing loss.
(c) Business Wire 2004