Medical Device Daily
The FDA has approved a new kind of hearing device made by Envoy Medical (Minneapolis) that the agency said represents a breakthrough technology to restore hearing.
Almost a year ago, Envoy CEO Patrick Spearman told Medical Device Daily, “The entire audiological community will fall out of their chairs when they see the Esteem. LASIK is to vision what Esteem will be to hearing“ (Medical Device Daily, April 21, 2009).
Traditional hearing aid technologies rely on microphones for amplification. Esteem uses the body's own eardrum as a natural microphone.
On Thursday, Spearman told MDD the Esteem would work for about 80%, or 24 million, of the 30 million Americans with sensorineural hearing impairment. “The benefit is going to be more than making money. The benefit to society is wonderful.“
But he's not shy about pointing out that cost of Esteem, $30,000 for the device and surgery, will take his small company over the top. And he's willing to share that with plans to go public in less than 15 months.
“We'll start doing the SEC filings within a few months,“ he said.
Envoy is already geared up to manufacture millions of devices in house.
“The FDA audited us,“ Spearman said. “After the meeting, the head of the audit group from FDA took me aside and said 'This is so unusual, we can't find anything wrong. We can't give you a ding.' That's a testament to the people in our organization.“
A totally implanted device similar to pacemaker technology, Esteem has two transducers – a sensor and a driver – that extend into the middle ear from the sound processor which is implanted just behind the ear. Sound waves travel into the ear canal and set the ear drum into motion causing the bones of the middle ear to vibrate. The device senses these movements and delivers a dose of energy to the cochlea, which then transmits the signals to the brain.
While cochlear implants were the first devices used that replaced a human sense, Esteem brings people back to normal levels of hearing, something that cochlear implants can't do.
A small remote control device allows users to turn the Esteem on or off at will, adjust volume if needed in different settings. Spearman said one of the biggest complaints that traditional hearing aid users have is that they can't filter out background noise like a natural ear. So if a TV is running in the background or if the person is in a noisy crowded room, it's difficult to hear a person speak even if they are very close. Esteem apparently avoids that problem.
In December, Envoy won a nod from the FDA ear, nose and throat devices advisory committee. One of the difficulties encountered by Envoy during the course of the pivotal trial was a substantial degree in difference of outcomes in the three study sites. One site produced 20 patients out of 21 whose hearing measures were at least as good as prior to the surgery, with only one whose hearing that tested worse, but a study site at which three of 15 had a worse measure torqued the numbers. FDA calculated a site sensitivity P score of 0.01, said to have demonstrated significant site effect. The application seemed to be in trouble by the time the meeting broke for lunch, but the afternoon open public hearing, with patients' testimony, seemed to nudge some of the panelists' attitudes and, indeed, may have proved decisive (MDD, Dec. 22, 2009).
One of the questions FDA posed to the panel was whether the rate of revision surgery, usually due to limited benefit, suggested a problem with safety.
Spearman told MDD on Thursday his company will pay the full cost of any revisions.
In a multicenter clinical study of Esteem vs. pre-implant hearing aids, 93% of Esteem recipients scored equal to or better than their pre-implant hearing aids on a speech intelligibility test. Seven percent scored less than with their pre-implant hearing aids, and 56% scored better than with their pre-implant hearing aids.
Seven percent of participants experienced facial paralysis, and 42% experienced taste disturbance, both of which are results of the surgical procedure necessary to implant the device. The majority of these adverse events resolved during the one-year study period.
As a condition of FDA approval, Envoy must conduct two post-approval studies. In one study, Envoy must continue to follow up on 61 subjects from the original study for five years to study safety and effectiveness. Another study of 120 newly enrolled subjects will include an evaluation of the incidence of facial paralysis at one month after implantation, and evaluate the effectiveness of Esteem five years after implantation.
Spearman said the next step is to train surgeons to implant the new device.
“We're building a surgical center in Houston that will be done in 90 days,“ he said. “The key thing is to train surgeons properly. We go through classrooms and then take them into the labs to train for the procedure. We want to start off slowly to make sure procedures are done properly.“
Sensorineural hearing loss is usually caused by genetic factors or damage to the inner ear resulting from noise, viral infections, or aging. The results are reductions in perception of sounds and in the ability to understand speech.
This differs from conductive hearing loss, which occurs when sound waves cannot transmit well through the outer or middle ear or both. Medical or surgical treatment can often restore hearing in people with a conductive hearing loss, which can be caused by earwax, fluid in the middle ear space, or a punctured eardrum.
A national advertising campaign is already in place and Envoy is prepared to offer consumer financing for the $30,000 device and procedure. Envoy has made no effort to obtain insurance reimbursement.
“How much would you pay to restore your hearing?“ he said, adding that many people could tap into their 401(k)s for the medical procedure with no penalties.
“If they put down $12,000 they can pay $390 month for five years,“ he said. “It's like a car payment. This is available to a lot more people than we might think.“
Lynn Yoffee; 770-361-4789